Publications by authors named "Francesco Panza"

312 Publications

Associations between nutritional frailty and 8-year all-cause mortality in older adults: The Salus in Apulia Study.

J Intern Med 2021 Aug 26. Epub 2021 Aug 26.

Unit of Data Sciences and Technology Innovation for Population Health, National Institute of Gastroenterology "Saverio de Bellis", Research Hospital, Castellana Grotte, 70013 Bari, Italy.

Introduction: Preventive nutritional management of frailty, a multidimensional intermediate status in the ageing process, may reduce the risk of adverse health-related outcomes. We investigated the ability of a measure combining physical frailty with nutritional imbalance, defined as nutritional frailty, to predict all-cause mortality over a period of up to 8 years.

Methods: We analysed data on 1,943 older adults from the population-based 'Salus in Apulia Study'. Physical frailty was operationalized using Cardiovascular Health Study criteria and cognitive frailty by combining physical frailty with cognitive impairment. A novel five-item construct was built to assess the extent of nutritional imbalance identified with a machine learning algorithm. Cox models and Kaplan-Meier survival probability analyses of physical frailty, nutritional imbalance (two or more of the following: low body mass index, low skeletal muscle index, ≥2.3 g/day sodium intake, <3.35 g/day potassium intake and <9.9 g/day iron intake), cognitive frailty and the novel nutritional frailty phenotype (physical frailty plus nutritional imbalance) were applied to assess all-cause mortality risk, adjusted for age, sex, education and multimorbidity.

Results: The overall prevalence of nutritional frailty was 4.52% (95% confidence interval, CI:3.55-5.44), being more frequent in males. Subjects with nutritional frailty were at higher risk for all-cause mortality [hazard ratio (HR):2.31; 95%CI:1.41-3.79] than those with physical frailty (HR:1.45,95% CI:1.0-2.02), nutritional imbalance (HR:1.39; 95%CI:1.05-1.83) and cognitive frailty (HR:1.06; 95%CI:0.56-2.01).

Conclusions: Efforts to identify, manage and prevent frailty should include the nutritional domain. The nutritional frailty phenotype may highlight major nutritional determinants that could drive survival and health trajectories in older adults.
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http://dx.doi.org/10.1111/joim.13384DOI Listing
August 2021

Liver frailty and all-cause mortality in the older participants of the Salus in Apulia Study.

Geroscience 2021 Aug 11. Epub 2021 Aug 11.

Unit of Data Sciences and Technology Innovation for Population Health, National Institute of Gastroenterology "Saverio de Bellis," Research Hospital, Castellana Grotte, Bari, Italy.

The liver contribution to the biological network underlying physical frailty in aging is underestimated. How best to measure this contribution magnitude and impact on health risk trajectories in frail individuals is not yet entirely clear. We analyzed the association of a novel liver frailty phenotype with the risk of death in older participants of the Salus in Apulia Study cohort. Clinical and physical examination, routine biomarkers, medical history, and anthropometry were analyzed in 1929 older adults (65 +). Physical frailty was classified by Cardiovascular Health Study criteria, and liver fibrosis risk by fibrosis-4 (FIB-4). The liver frailty phenotype was defined as physical frailty plus high-risk liver fibrosis (score > 2.67). Physical frailty, high-risk liver fibrosis, and liver frailty subjects were compared to subjects without these conditions (non-frail). Proportional Cox regression tested the adjusted association between liver frailty and all-cause mortality for each category. The liver frailty prevalence was relatively low (3.8%), but higher in men (58.1%). Compared to non-frail older subjects, liver frailty subjects were significantly older (effect size (ES) - 1.11, 95% confidence interval (CI) - 1.35 to - 0.87), with a lower education (ES 0.48, 95%CI 0.24 to 0.71) and higher multimorbidity (ES 15.81, 95%CI 4.20 to 27.41). Cox multivariate analyses showed a two-fold increased risk of overall mortality (hazard ratio 2.09, 95%CI 1.16-3.74) even after the adjustment for age, sex, education, and alcohol consumption. The liver frailty phenotype runs twice the risk of overall mortality compared with the non-frail population. This clinical tool, validated in a Southern Italian population, is based on simple sets of measures that can conveniently be assessed also in the primary care setting.
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http://dx.doi.org/10.1007/s11357-021-00434-xDOI Listing
August 2021

COVID-19 clinical phenotypes and short-term outcomes: differences between the first and the second wave of pandemic in Italy.

Expert Rev Respir Med 2021 Aug 18:1-7. Epub 2021 Aug 18.

Institute of Respiratory Disease, Department of Basic Medical Science, Neuroscience, and Sense Organs, University of Bari, "Aldo Moro", Bari, Italy.

There are no comparative studies between patients belonging to the first and second waves of the SARS-CoV-2 pandemic, the virus triggering coronavirus disease 2019 (COVID-19). In this retrospective observational study, we analyzed the clinical characteristics and the short-term outcomes of two groups of laboratory-confirmed COVID-19 patients with moderate-to-severe acute respiratory distress syndrome (ARDS) belonging to two different waves of the pandemic.  We analyzed 97 consecutive patients from 11 March 2020 to 31 May 2020 and 52 consecutive patients from 28 August 2020 to 15 October 2020.  Patients belonging to the second wave were younger, had a lower number of concomitant chronic conditions (multimorbidity), and had a milder clinical phenotype. Medical treatments and respiratory support use have changed during the COVID-19 pandemic, based on different laboratory results and disease clinical features. Patients in the second wave had better short-term clinical outcomes, with lower death rates and more step-down transfers to a general ward.  The present findings show a clear phenotypic difference in patients hospitalized at different stages of the COVID-19 pandemic in Italy. These results can help to stratify clinical risk and to better tailor medical treatments and respiratory support for patients with ARDS and COVID-19 pneumonia.
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http://dx.doi.org/10.1080/17476348.2021.1960824DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8436419PMC
August 2021

Cross-sectional and longitudinal associations between adherence to Mediterranean diet with physical performance and cognitive function in older adults: A systematic review and meta-analysis.

Ageing Res Rev 2021 09 19;70:101395. Epub 2021 Jun 19.

National Institute of Gastroenterology "Saverio de Bellis", Research Hospital, Castellana Grotte, Bari, Italy. Electronic address:

Objectives: The present study investigated the association between adherence to Mediterranean diet (MeDi) and physical performance and cognitive function in older adults.

Methods: We conducted a systematic review and meta-analysis of cross-sectional and longitudinal studies that investigated older adults aged 60+ years and assessed adherence to MeDi diet using validated composite scores. Observational studies, including cross-sectional, case-control, and longitudinal cohort studies, if crude baseline data was available, which investigated as a primary or secondary outcome the association of MeDi diet adherence with physical performance and/or cognitive function in non-demented older adults were included in the cross-sectional analysis. For the longitudinal analysis, case-control and longitudinal cohort studies that investigated the longitudinal associations between adherence to MeDi diet with the incidence of mild cognitive impairment (MCI), dementia, and/or Alzheimer's disease (AD), and/or changes in physical performance and cognition in non-demented older adults were included. Studies published in other languages than English were excluded. Studies were retrieved from MEDLINE, SCOPUS, CINAHL, and AgeLine databases until May 19, 2021. The risk of bias was evaluated using the Newcastle - Ottawa Quality Assessment Scale (NOS). A pooled effect size was calculated based on standard mean differences (SMD), log odds ratio (OR) and log risk ratio (RR). This study is registered on PROSPERO (CRD42021250254).

Results: Nineteen cross-sectional studies that investigated 19.734 community-dwelling and institutionalized older adults free of disability and dementia were included. A high adherence to MeDi was cross-sectionally associated with better walking speed (SMD = 0.42; 95 % Confidence Interval (CI) = 0.12-0.72, P = 0.006; I² = 65 %, P = 0.06), knee muscle strength speed (SMD = 0.26; 95 % CI = 0.17-0.36, P < 0.00001; I² = 0 %, P = 0.69), global cognition (SMD = 0.24; 95 % CI = 0.15-0.33, P < 0.00001; I² = 85 %, P < 0.00001), and memory (SMD = 0.18; 95 % CI = 0.13-0.25, P < 0.00001; I² = 100 %, P < 0.00001). The association between MeDi adherence and global cognition remained significant after stratifying the analysis by the region where the study was conducted, MeDi diet adherence composite score, and Mini Mental State Examination (MMSE). Studies had a moderate to low risk of bias. In relation to longitudinal analysis, thirty-four prospective studies with an average follow-up period that varied from 3.0 to 12.6 years and investigated 98.315 community-dwellers were included. Results indicated that older adults with high MeDi scores had a lower decline in global cognition RR = 0.26; 95 % CI = 0.23-0.29, P < 0.00001; I² = 100 %, P < 0.00001). In contrast, no significant associations between MeDi and mobility, MCI, dementia were found. A low risk of bias was found in the longitudinal studies.

Discussion: Findings of the present study indicated that high adherence to MeDi was cross-sectionally associated with physical performance and cognitive function. Results of the pooled analysis of longitudinal studies revealed that high adherence to MeDi reduced the risk of global cognitive decline in non-demented older adults. However, no significant associations between MeDi adherence and the incidence of mobility problems, MCI, and dementia were found. Although important, our findings should be carefully interpreted due to the presence of heterogeneity and publication bias.
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http://dx.doi.org/10.1016/j.arr.2021.101395DOI Listing
September 2021

Dietary Habits and Nutrient Intakes Are Associated to Age-Related Central Auditory Processing Disorder in a Cohort From Southern Italy.

Front Aging Neurosci 2021 6;13:629017. Epub 2021 May 6.

Unit of Research Methodology and Data Sciences for Population Health, "Salus in Apulia Study" National Institute of Gastroenterology "S. de Bellis" Research Hospital, Bari, Italy.

Objectives: Central auditory processing disorder (CAPD) commonly occurs in older age. However, few studies of a possible link between age-related CAPD and diet in an older population have been conducted. The objective of the present study was to investigate the relationship between eating habits and age-related CAPD in a population >65 years, using cross-sectional and retrospective data obtained in the same population-based study about 12 years ago.

Methods: We selected 734 participants (403 men) from a large population-based study. For age-related CAPD assessment, we used the Synthetic Sentence Identification with Ipsilateral Competitive Message test. Dietary habits were assessed by a Food Frequency Questionnaire. Associations between age-related CAPD and food groups/macro-and micronutrients were explored using adjusted logistic regression models.

Results: Age-related CAPD subjects consumed more dairy (111 vs. 98 g/d), olives and vegetable oil (63 vs. 52 g/d) and spirits (2 vs.1 g/d), and less fruits (536 vs. 651 g/d) in the cross-sectional analysis. Age-related CAPD subjects had a lower intake of potassium, vitamin C, and a higher fat intake. Further analyses identified dietary fiber as being inversely related to age-related CAPD.

Discussion: The present study provided evidence that the dietary hypotheses proposed for explaining the development of cognitive disorders in older age might also hold for age-related CAPD. Further data from other large and prospective population-based studies are needed for confirming these findings.
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http://dx.doi.org/10.3389/fnagi.2021.629017DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8134698PMC
May 2021

Non Alcoholic Fatty Liver Disease Is Positively Associated with Increased Glycated Haemoglobin Levels in Subjects without Diabetes.

J Clin Med 2021 Apr 15;10(8). Epub 2021 Apr 15.

Unit of Research Methodology and Data Sciences for Population Health, National Institute of Gastroenterology "Saverio de Bellis", Research Hospital, Castellana Grotte, 70013 Bari, Italy.

Screening for non-alcoholic fatty liver disease (NAFLD) is key step for primary management of fatty liver in the clinical setting. Excess weight subjects carry a greater metabolic risk even before exhibiting pathological patterns, including diabetes. We characterized the cross-sectional relationship between routine circulating biomarkers and NAFLD in a large sample of diabetes-free subjects with overweight or obesity, to elucidate any independent relationship. A population sample of 1232 consecutive subjects with a body mass index of at least 25 kg/m, not receiving any drug or supplemental therapy, was studied. Clinical data and routine biochemistry were analyzed. NAFLD was defined using the validated fatty liver index (FLI), classifying subjects with a score ≥ 60% as at high risk. Due to extreme skewing of variables of interest, resampling matching for age and sex was performed. Our study population was characterized by a majority of females (69.90%) and a prevalence of NAFLD in males (88.90%). As a first step, propensity score matching was explicitly performed to balance the two groups according to the FLI cut-off. Based on the resulting statistical trajectories, corroborated even after data matching, we built two logistic regression models on the matched population ( = 732) to verify any independent association. We found that each unit increase of FT3 implicated a 50% increased risk of NAFLD (OR 1.506, 95%CI 1.064 to 2.131). When including glycated haemoglobin (HbA1c) in the model, free-triiodothyronine (FT3) lost significance (OR 1.557, 95%CI 0.784 to 3.089) while each unit increase in HbA1c (%) indicated a significantly greater NAFLD risk, by almost two-fold (OR 2.32, 95%CI 1.193 to 4.512). Glucose metabolism dominates a key pathway along the hazard trajectories of NAFLD, turned out to be key biomarker in monitoring the risk of fatty liver in diabetes-free overweight subjects. Each unit increase in HbA1c (%) indicated a significantly greater NAFLD risk, by almost two-fold, in our study.
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http://dx.doi.org/10.3390/jcm10081695DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8071132PMC
April 2021

Physical and cognitive profiles in motoric cognitive risk syndrome in an older population from Southern Italy.

Eur J Neurol 2021 08 14;28(8):2565-2573. Epub 2021 May 14.

Unit of Research Methodology and Data Sciences for Population Health, "Salus in Apulia Study,", National Institute of Gastroenterology "Saverio de Bellis," Research Hospital, Castellana Grotte, Italy.

Background And Purpose: In older age, physical and cognitive declines have been shown to occur simultaneously or consequent to one another, and several operational definitions have been proposed to consider the co-presence of the two declines; for example, "Motoric cognitive risk syndrome" (MCR) has been proposed as a definition for the coexistence of slow gait plus subjective cognitive complaints. Given the increasing interest in MCR and its potential role as both biomarker and therapeutic target, we aimed to estimate its prevalence in a large cohort of non-demented older subjects, and to examine the associations between physical status, global cognitive dysfunction, and impairment in various cognitive domains in MCR.

Methods: A population-based sample of 1041 older people in Southern Italy (mean age 75.15 years) was enrolled. We defined MCR using slowness and a single question for subjective cognitive complaints. We also administered a comprehensive neuropsychological test battery, together with tests assessing physical function.

Results: The prevalence of MCR was 9.9% (95% confidence interval 8.2-11.9). MCR was associated with decreased processing speed and executive function after adjusting for all relevant confounders. However, we found no significant association of MCR with decreased global cognition and immediate/delayed free recall of verbal memory. MCR was also associated with increased exhaustion, low muscle strength, and low physical activity, and increased levels of C-reactive protein and interleukin-6.

Conclusions: The present findings on MCR prevalence and associated cognitive and physical domains and inflammatory biomarkers may help to uncover altered pathways and therapeutic targets for intervention during the long preclinical phase of neurodegenerative dementia.
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http://dx.doi.org/10.1111/ene.14882DOI Listing
August 2021

Physical and cognitive profiles in motoric cognitive risk syndrome in an older population from Southern Italy.

Eur J Neurol 2021 08 14;28(8):2565-2573. Epub 2021 May 14.

Unit of Research Methodology and Data Sciences for Population Health, "Salus in Apulia Study,", National Institute of Gastroenterology "Saverio de Bellis," Research Hospital, Castellana Grotte, Italy.

Background And Purpose: In older age, physical and cognitive declines have been shown to occur simultaneously or consequent to one another, and several operational definitions have been proposed to consider the co-presence of the two declines; for example, "Motoric cognitive risk syndrome" (MCR) has been proposed as a definition for the coexistence of slow gait plus subjective cognitive complaints. Given the increasing interest in MCR and its potential role as both biomarker and therapeutic target, we aimed to estimate its prevalence in a large cohort of non-demented older subjects, and to examine the associations between physical status, global cognitive dysfunction, and impairment in various cognitive domains in MCR.

Methods: A population-based sample of 1041 older people in Southern Italy (mean age 75.15 years) was enrolled. We defined MCR using slowness and a single question for subjective cognitive complaints. We also administered a comprehensive neuropsychological test battery, together with tests assessing physical function.

Results: The prevalence of MCR was 9.9% (95% confidence interval 8.2-11.9). MCR was associated with decreased processing speed and executive function after adjusting for all relevant confounders. However, we found no significant association of MCR with decreased global cognition and immediate/delayed free recall of verbal memory. MCR was also associated with increased exhaustion, low muscle strength, and low physical activity, and increased levels of C-reactive protein and interleukin-6.

Conclusions: The present findings on MCR prevalence and associated cognitive and physical domains and inflammatory biomarkers may help to uncover altered pathways and therapeutic targets for intervention during the long preclinical phase of neurodegenerative dementia.
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http://dx.doi.org/10.1111/ene.14882DOI Listing
August 2021

Oral frailty and neurodegeneration in Alzheimer's disease.

Neural Regen Res 2021 Nov;16(11):2149-2153

Frailty Phenotypes Research Unit, "Salus in Apulia Study", National Institute of Gastroenterology "Saverio de Bellis", Research Hospital, Castellana Grotte, Bari, Italy.

Frailty is a critical intermediate status of the aging process with a multidimensional and multisystem nature and at higher risk for adverse health-related outcomes, including falls, disability, hospitalizations, institutionalization, mortality, dementia, and Alzheimer's disease. Among different frailty phenotypes, oral frailty has been recently suggested as a novel construct defined as a decrease in oral function with a coexisting decline in cognitive and physical functions. We briefly reviewed existing evidence on operational definitions of oral frailty, assessment and screening tools, and possible relationships among oral frailty, oral microbiota, and Alzheimer's disease neurodegeneration. Several underlying mechanism may explain the oral health-frailty links including undernutrition, sarcopenia linked to both poor nutrition and frailty, psychosocial factors, and the chronic inflammation typical of oral disease. Oral microbiota may influence Alzheimer's disease risk through circulatory or neural access to the brain and the interplay with periodontal disease, often causing tooth loss also linked to an increased Alzheimer's disease risk. On this bases, COR388, a bacterial protease inhibitor targeting Porphyromonas gingivalis implicated in periodontal disease, is now being tested in a double-blind, placebo-controlled Phase II/III study in mild-to-moderate Alzheimer's disease. Therefore, oral status may be an important contributor to general health, including Alzheimer's disease and late-life cognitive disorders, suggesting the central role of preventive strategies targeting the novel oral frailty phenotype and including maintenance and improvement of oral function and nutritional status to reduce the burden of both oral dysfunction and frailty.
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http://dx.doi.org/10.4103/1673-5374.310672DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8354109PMC
November 2021

How gait influences frailty models and health-related outcomes in clinical-based and population-based studies: a systematic review.

J Cachexia Sarcopenia Muscle 2021 04 16;12(2):274-297. Epub 2021 Feb 16.

Population Health Unit - "Salus In Apulia Study", National Institute of Gastroenterology "Saverio de Bellis", Research Hospital, Castellana Grotte, Bari, Italy.

Aging is often associated with a decline in physical function that eventually leads to loss of autonomy in activities of daily living (ADL). Walking is a very common ADL, important for main determinants of quality of life in older age, and it requires the integration of many physiological systems. Gait speed has been described as the 'sixth vital sign' because it is a core indicator of health and function in aging and disease. We reviewed original studies up to June 2020 that assessed frailty in both longitudinal and cross-sectional observational studies, paying particular attention to how gait is measured in older population and how the gait parameter adopted may influence the estimated frailty models and the health-related outcomes of the various studies (i.e. clinical, cognitive, physical, and nutritional outcomes). Eighty-five studies met the search strategy and were included in the present systematic review. According to the frailty tools, more than 60% of the studies used the physical phenotype model proposed by Fried and colleagues, while one-third referred to multi-domain indexes or models and only 5% referred to other single-domain frailty models (social or cognitive). The great heterogeneity observed in gait measurements and protocols limited the possibility to directly compare the results of the studies and it could represent an important issue causing variability in the different outcome measures in both clinical-and population-based settings. Gait appeared to be an indicator of health and function also in frail older adults, and different gait parameters appeared to predict adverse health-related outcomes in clinical, cognitive, and physical domains and, to a lesser extent, in nutritional domain. Gait has the potential to elucidate the common basic mechanisms of cognitive and motor decline. Advances in technology may extend the validity of gait in different clinical settings also in frail older adults, and technology-based assessment should be encouraged. Combining various gait parameters may enhance frailty prediction and classification of different frailty phenotypes.
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http://dx.doi.org/10.1002/jcsm.12667DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8061366PMC
April 2021

Association Between Central and Peripheral Age-Related Hearing Loss and Different Frailty Phenotypes in an Older Population in Southern Italy.

JAMA Otolaryngol Head Neck Surg 2021 06;147(6):561-571

Population Health Unit, Salus in Apulia Study, National Institute of Gastroenterology Saverio de Bellis, Research Hospital, Castellana Grotte, Bari, Italy.

Importance: The association between age-related hearing loss (ARHL) and physical or cognitive frailty has been poorly explored. These associations could define new perspectives for delaying frailty-related processes in older age.

Objective: To examine whether peripheral ARHL and age-related central auditory processing disorder (CAPD) are independently associated with physical or cognitive frailty.

Design, Setting, And Participants: This cross-sectional study analyzed registry data from December 31, 2014, on 1929 older (≥65 years) participants of the Salus in Apulia Study (Southern Italy) who underwent audiologic, physical, and neuropsychological assessment. Data analysis was performed from December 12, 2019, to January 4, 2020.

Main Outcomes And Measures: Prevalence of peripheral ARHL in older individuals with physical and/or cognitive frailty and those without frailty assessed using the Fried criteria (physical) and the Mini-Mental State Examination (cognitive). Multivariable logistic regression models were used to assess associations of audiologic variables with frailty phenotype.

Results: Data from 1929 participants (mean [SD] age, 73.6 [6.3] years; 974 male [50.5%]) were eligible for the analyses. The prevalence of peripheral ARHL was higher in the physical frailty group (96 [26.6%]) than in the nonfrail group (329 [21.0%]) (difference, 5.61 percentage points; 95% CI, 0.63-10.59 percentage points) and in the cognitive frailty group (40 [38.8%]) than in the nonfrail group (385 [21.1%]) (difference, 17.75 percentage points; 95% CI, 8.2-27.3 percentage points). Age-related CAPD was more prevalent in the physical frailty group (62 [17.2%]) than in the nonfrail group (219 [14.0%]) (difference, 3.21 percentage points; 95% CI, -1.04 to 7.46 percentage points) and in the cognitive frailty group (28 [27.2%]) than in the nonfrail group (253 [13.9%]) (difference, 13.33 percentage points; 95% CI, 4.10-22.21 percentage points). In the multivariable models, age-related CAPD was associated with cognitive frailty in the fully adjusted model (odds ratio [OR], 1.889; 95% CI, 1.094-3.311). There was also an inverse association between the unitary increase in Synthetic Sentence Identification With the Ipsilateral Competitive Message scores, indicating a lower likelihood of this disorder, and cognitive frailty (OR, 0.989; 95% CI, 0.988-0.999). Peripheral ARHL was associated with cognitive frailty only in the partially adjusted model (OR, 1.725; 95% CI, 1.008-2.937).

Conclusions And Relevance: In this cross-sectional study of 1929 participants, age-related CAPD was independently associated with cognitive frailty. Whether the management of ARHL may help prevent the development of different frailty phenotypes or improve their clinical consequences should be addressed in longitudinal studies and, eventually, well-designed randomized clinical trials.
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http://dx.doi.org/10.1001/jamaoto.2020.5334DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7879383PMC
June 2021

Physical Frailty, Multimorbidity, and All-Cause Mortality in an Older Population From Southern Italy: Results from the Salus in Apulia Study.

J Am Med Dir Assoc 2021 03 23;22(3):598-605. Epub 2021 Jan 23.

Healthy Aging Phenotypes Research Unit - "Salus in Apulia Study" - National Institute of Gastroenterology "Saverio de Bellis", Research Hospital, Bari, Italy. Electronic address:

Objectives: We first estimated the prevalence of physical frailty in older subjects from the population-based Salus in Apulia Study (Apulia, Southern Italy), and its impact on all-cause mortality. Second, we explored the relationship between multimorbidity and physical frailty.

Design: Cross-sectional and longitudinal analyses from a population-based study.

Setting And Participants: We analyzed data from the Salus in Apulia study, a population-based sample of 1929 subjects aged 65 years and older.

Methods: These older participants underwent clinical, physical, and laboratory assessments. Physical frailty was operationalized using slightly modified Fried criteria. Multimorbidity status was defined as the co-presence of 2 or more chronic conditions.

Results: The overall prevalence of physical frailty in this older population from Southern Italy was 14.8% [95% confidence interval (CI): 13.26-16.49]. Physical frailty subjects were significantly older (P < .01), had a lower educational level (P < .01), increased executive dysfunction (P < .01), higher serum levels interleukin-6 (P < .01), and white blood cells (P = .01). Multimorbidity status (P < .01), diabetes mellitus (P = .05), peripheral age-related hearing loss (P < .01), cognitive impairment (P < .01), chronic obstructive pulmonary disease (P = .02), and metabolic syndrome (P = .02) were also directly related to physical frailty. Apathy increased according to the severity of physical frailty status (P = .02). There was a significant increased risk of all-cause mortality for physical frailty subjects (hazard ratio: 1.48; 95% CI: 1.03-2.12, adjusted for age and sex) during the observation from the date of enrollment to the date of death (mean ± SD: 55.70 ± 22.19 months, median: 54 months).

Conclusions And Implications: Frailty is the consequence of the contributory action of the aging process and some chronic diseases that hasten some of the changes concurrent with aging.
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http://dx.doi.org/10.1016/j.jamda.2020.12.026DOI Listing
March 2021

More skilled clinical management of COVID-19 patients modified mortality in an intermediate respiratory intensive care unit in Italy.

Respir Res 2021 Jan 15;22(1):16. Epub 2021 Jan 15.

Department of Basic Medical Science, Institute of Respiratory Disease, Neuroscience, and Sense Organs, University of Bari "Aldo Moro", Bari, Italy.

Background: Some studies investigated epidemiological and clinical features of laboratory-confirmed patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) the virus causing coronavirus disease 2019 (COVID-19), but limited attention has been paid to the follow-up of hospitalized patients on the basis of clinical setting and the expertise of clinical management.

Methods: In the present single-centered, retrospective, observational study, we reported findings from 87 consecutive laboratory-confirmed COVID-19 patients with moderate-to-severe acute respiratory syndrome hospitalized in an intermediate Respiratory Intensive Care Unit (RICU), subdividing the patients in two groups according to the admission date (before and after March 29, 2020).

Results: With improved skills in the clinical management of COVID-19, we observed a significant lower mortality in the T2 group compared with the T1 group and a significantly difference in terms of mortality among the patients transferred in Intensive Care Unit (ICU) from our intermediate RICU (100% in T1 group vs. 33.3% in T2 group). The average length of stay in intermediate RICU of ICU-transferred patients who survived in T1 and T2 was significantly longer than those who died (who died 3.3 ± 2.8 days vs. who survived 6.4 ± 3.3 days).

T Conclusions: The present findings suggested that an intermediate level of hospital care may have the potential to modify survival in COVID-19 patients, particularly in the present phase of a more skilled clinical management of the pandemic.
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http://dx.doi.org/10.1186/s12931-021-01613-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7809547PMC
January 2021

Role of plant-based diet in late-life cognitive decline: results from the Salus in Apulia Study.

Nutr Neurosci 2021 Jan 15:1-10. Epub 2021 Jan 15.

Healthy Aging Phenotypes Research Unit - 'Salus in Apulia Study' - National Institute of Gastroenterology 'Saverio de Bellis', Research Hospital, Bari, Italy.

Objectives: Consistency among population-based studies investigating the relationship between diet and cognition in older inhabitants in the Mediterranean area is poor. The present study investigated whether diet changes over 12 years were associated with cognitive function in older people in Southern-Italy.

Methods: From the 'Salus in Apulia Study', that includes the MICOL and GreatAGE Studies, 584 participants were selected, firstly enrolled in MICOL3 (M3) and later in the GreatAGE Study (MICOL4, M4). Foods and micronutrients intake were recorded in both studies, and global cognitive function in M4, assessed with the Mini Mental State Examination.

Results: Plant-based foods, particularly coffee and vegetables, as well as vitamin A sources, were inversely associated to age-related cognitive impairment. Alcohol consumption showed a detrimental role on cognition, while red meat appeared to be beneficial in the present study, although its role is traditionally considered harmful for cognitive function.

Discussion: Our study confirmed that a traditional Mediterranean dietary pattern based on agricultural products and low alcohol consumption may help to prevent/delay age-related cognitive impairment.
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http://dx.doi.org/10.1080/1028415X.2020.1853416DOI Listing
January 2021

Vitamin D in the development and progression of alzheimer's disease: implications for clinical management.

Expert Rev Neurother 2021 Mar 18;21(3):287-301. Epub 2021 Jan 18.

Neurodegenerative Disease Unit, Department of Basic Medicine, Neuroscience, and Sense Organs, University of Bari Aldo Moro, Bari, Italy.

Introduction: Although the pathophysiological bases of Alzheimer's disease (AD) remain incompletely understood and disease-modifying therapies are not available, intervention on modifiable risk factors is warranted. Research on nutrition and dietary components is challenging and controversies still persist about the role of micro- and macronutrients and health outcomes in dementia. Importantly, results of preclinical investigations have shown that vitamin D triggers different neural pathways that may be protective against these neurodegenerative mechanisms, including the deposition of amyloid plaques, inflammatory processes, neurofibrillary degeneration, glutamatergic excitotoxicity, excessive intraneuronal calcium influx, and oxidative stress, although its relationship with AD still needs to be fully understood.

Areas Covered: The authors analyzed the recent evidence about the effects of vitamin D insufficiency on AD and the role of supplementation.

Expert Opinion: Both insufficient (25-49.9 ng/ml) and deficient levels (<25 ng/ml) of vitamin D may contribute to an increased susceptibility to AD. However, further well-designed prospective studies are needed for a better understanding of the involvement of low vitamin D concentrations in the AD natural history. Randomized clinical trials will also be necessary to address the issue of causality and determine whether vitamin D supplementation may be effective for the prevention or treatment of AD.
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http://dx.doi.org/10.1080/14737175.2021.1873768DOI Listing
March 2021

Bilevel and continuous positive airway pressure and factors linked to all-cause mortality in COVID-19 patients in an intermediate respiratory intensive care unit in Italy.

Expert Rev Respir Med 2021 06 23;15(6):853-857. Epub 2020 Dec 23.

Institute of Respiratory Disease, Department of Basic Medical Science, Neuroscience, and Sense Organs, University of Bari "Aldo Moro", Bari, Italy.

: In the present single-centered, retrospective, observational study, we reported findings from 78 consecutive laboratory-confirmed COVID-19 patients with moderate-to-severe acute respiratory distress syndrome (ARDS) hospitalized in an intermediate Respiratory Intensive Care Unit, subdividing the patients into two groups according to their clinical outcome, dead patients and discharged patients.: We further subdivided patients depending on the noninvasive respiratory support used during hospitalization.: In those patients who died, we found significant older age and higher multimorbidity and higher values of serum lactate dehydrogenase, C-reactive protein, and D-dimer. Among patients who were submitted to bilevel positive airway pressure (BPAP), those who died had a significant shorter number of days in overall length of stay and lower values of arterial oxygen partial pressure to fractional inspired oxygen ratio (PaO2/FiO2 ratio) compared to those who survived. No difference in all-cause mortality was observed between the two different noninvasive respiratory support groups [48% for continuous positive airway pressure (CPAP) and 52% for BPAP].: In COVID-19 patients with moderate-to-severe ARDS using BPAP in an intermediate level of hospital care had more factors associated to all-cause mortality (shorter length of stay and lower baseline PaO2/FiO2 ratio) compared to those who underwent CPAP.
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http://dx.doi.org/10.1080/17476348.2021.1866546DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7784777PMC
June 2021

Social Frailty in the COVID-19 Pandemic Era.

Front Psychiatry 2020 3;11:577113. Epub 2020 Nov 3.

Population Health Unit - "Salus in Apulia Study" - National Institute of Gastroenterology "Saverio de Bellis," Research Hospital, Bari, Italy.

Special attention and efforts to protect from or reduce health-related outcomes of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus triggering coronavirus disease 2019 (COVID-19), should be applied in susceptible populations, including frail older people. In particular, the early death cases occurred primarily in older people with a frailty status, possibly due to a weaker immune system fostering faster progression of the viral infection. Frailty is an age-related multidimensional clinical condition defined as a non-specific state of vulnerability, identifying older people at increased risk of falls, institutionalization, hospitalization, disability, dementia, and death. Among frailty phenotypes, social frailty has been least studied. It considers the role of socioeconomic context as a vulnerability status later in life. COVID-19 does not affect all populations equally, and social inequalities contribute to drive the spread of infections. It was known that the perception of social isolation, e.g., loneliness, affects mental and physical health, but the implicated molecular mechanisms, also related to the immune system, and its associated cognitive and health-related sequelae, are poorly understood. The increasing psychological distress derived by prolonged exposure to stress due to the lockdown scenario, and the reduced sources of support, contributed to making heavy demands on personal resources, i.e., self-efficacy and interpersonal variables. So, perceived loneliness may be a factor associated with psychological distress and an outcome in itself. In the COVID-19 pandemic era, a correct assessment of social frailty may be essential in terms of the prevention of late-life neuropsychiatric disorders.
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http://dx.doi.org/10.3389/fpsyt.2020.577113DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7669751PMC
November 2020

Late-life depression and its impact on rehabilitation after traumatic injuries.

Aging Clin Exp Res 2021 08 6;33(8):2313-2316. Epub 2020 Nov 6.

Unit of Epidemiological Research On Aging, National Institute of Gastroenterology 'Saverio de Bellis', Research Hospital, Castellana Grotte, Bari, Italy.

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http://dx.doi.org/10.1007/s40520-020-01744-4DOI Listing
August 2021

Late-onset depression is associated to age-related central auditory processing disorder in an older population in Southern Italy.

Geroscience 2021 04 31;43(2):1003-1014. Epub 2020 Oct 31.

Population Health Unit - "Salus In Apulia Study", National Institute of Gastroenterology "Saverio de Bellis," Research Hospital, Castellana Grotte, Bari, Italy.

The association between late-life depression (LLD) and age-related hearing loss (ARHL) was suggested by preliminary studies, but reliance on LLD subtypes may introduce significant bias. We examined the association between ARHL and LLD according to the age of onset (early-onset depression (EOD) and late-onset depression (LOD)). We investigated the association between ARHL and LLD diagnosed according to the Semi-structured Clinical Diagnostic Interview for DSM-IV-TR in 1749 Italian community-dwelling older subjects from the population-based GreatAGE Study, Southern Italy. Peripheral ARHL was assessed as a pure tone average (PTA) threshold > 40 dB hearing level in the better ear- and age-related CAPD as a score of < 50% to the Synthetic Sentences Identification with Ipsilateral Competitive Message (SSI-ICM) test. LLD amounted at 10.29% of the sample, subdivided in LOD (6.21%) and EOD (4.08%). Age-related CAPD tended to be higher in LOD (28.91%) than in EOD (19.05%). After accounting for covariates, LOD was tendentially associated to age-related CAPD, but not to peripheral ARHL. This trend was confirmed by the linear models in which LOD was significantly associated to worsen SSI-ICM percentages (odds ratio 2.38, 95% confidence interval 1.32-4.30, p = 0.004), but not to PTA values. In a fully adjusted model of LOD, the effect of the association between CAPD and LOD was explained by social dysfunction. LLD was not associated to peripheral ARHL. Age-related CAPD was associated to LOD, a form of depression with cognitive dysfunction hallmark. The ARHL assessment may be an important opportunity to prevent depressive disorders in later life, particularly for LOD.
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http://dx.doi.org/10.1007/s11357-020-00290-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8110676PMC
April 2021

Adherence to a Mediterranean Diet and Thyroid Function in Obesity: A Cross-Sectional Apulian Survey.

Nutrients 2020 Oct 16;12(10). Epub 2020 Oct 16.

Population Health Unit-"Salus in Apulia Study"-National Institute of Gastroenterology-Research Hospital, IRCCS "S. De Bellis", Castellana Grotte, 70013 Bari, Italy.

Much research suggests that Mediterranean eating habits and lifestyle contribute to counteract the risk of chronic diseases while promoting longevity, but little information is available on the effects of the Mediterranean diet (Med-Diet) on thyroid function, particularly among overweight/obese subjects. Nevertheless, consistent data reported a slight increase in serum levels of the thyroid-stimulating hormone (TSH) and a higher rate of conversion of thyroxine (T4) to triiodothyronine (T3) in obesity. This cross-sectional study was aimed at investigating the relationship between adherence to the Med-Diet and circulating thyroid hormones in a cohort of overweight/obese subjects from Apulia (Southern Italy). We studied 324 consecutive outpatient subjects (228 women and 96 men, age range 14-72 years) taking no drug therapy and showing normal levels of thyroid hormones, but complicated by overweight and obesity (body mass index (BMI) ≥ 25 Kg/m). The PREDIMED (PREvención con DIeta MEDiterránea) questionnaire was cross-sectionally administered to assess the adherence to the Med-Diet, and hormonal, metabolic, and routine laboratory parameters were collected. Higher adherence to Med-Diet was found to be inversely related to free T3 ( < 0.01) and T4 ( < 0.01) serum levels. Considering each item in the PREDIMED questionnaire, people consuming at least four spoonfuls of extra-virgin olive oil (EVOO) per day, as well as those consuming at least two servings of vegetables per day, had lower free T3 levels ( 0.033 and 0.021, respectively). Furthermore, consuming at least four spoonfuls of EVOO per day was found to be associated to lower free T4 serum concentrations ( 0.011). Multinomial logistic regression models, performed on tertiles of thyroid hormones to further investigate the relationship with Med-Diet, corroborated the significance only for free T4. Increased adherence to the Med-Diet was independently associated to a slightly reduced thyroid function, but still within the reference range for free T3 and T4 serum levels. This first finding in this field opens up a research line on any underlying biological interplay.
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http://dx.doi.org/10.3390/nu12103173DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7603040PMC
October 2020

Retinal Vascular Density on Optical Coherence Tomography Angiography and Age-related Central and Peripheral Hearing Loss in a Southern Italian Older Population.

J Gerontol A Biol Sci Med Sci 2020 Oct 17. Epub 2020 Oct 17.

Otolaryngology Unit, Department of Basic Medical Science, Neuroscience and Sense Organs, University of Bari Aldo Moro, Bari, Italy.

Background: Age-related hearing loss (ARHL) and retinal vessel changes have both been associated to neurodegeneration/dementia, suggesting a possible link between these two conditions in older age. We aimed to determine whether superficial and deep vascular density (SVD and DVD) of the capillary plexi of macular vasculature can be associated with peripheral ARHL and age-related central auditory central processing (CAPD).

Methods: We analyzed data on 886 older participants (65 years+, age range:65-92 years) in the cross-sectional population-based Salus in Apulia Study. Optical coherence tomography angiography (OCT-A) was used to measure SVD and DVD of the capillary plexi of the macula at the 3-mm circle area centered on the fovea (whole retina), the parafoveal quadrant, and foveal quadrant. Disabling peripheral ARHL was defined as >40 dB HL of pure tone average on the frequencies from 0.5, 1, 2, and 4 KHz in the better ear, and age-related CAPD as <50% at the Synthetic Sentence Identification with Ipsilateral Competitive Message test in at least one ear.

Results: DVD at the whole retina and at the parafoveal quadrant were inversely associated only with age-related CAPD [odds ratio (OR):0.93; 95% confidence interval (CI): 0.88-0.96 and OR:0.94; 95 CI:0.90-0.99, respectively]. No further associations with peripheral ARHL were evident.

Conclusions: Retinal vasculature is associated with central auditory processing pathology, possibly playing an important role in early detection and intervention. The association of retinal vascular density with age-related CAPD may bring us a further step forward in understanding the biological mechanisms underlying the links between neurodegeneration/dementia and ARHL.
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http://dx.doi.org/10.1093/gerona/glaa269DOI Listing
October 2020

Pharmacological management of dementia with Lewy bodies with a focus on zonisamide for treating parkinsonism.

Expert Opin Pharmacother 2021 Feb 6;22(3):325-337. Epub 2020 Oct 6.

Department of Research and Development, Chiesi Farmaceutici, Parma , Italy.

Introduction: Dementia with Lewy bodies (DLB) has no approved symptomatic or disease-modifying treatments in the US and Europe, despite being the second most common cause of neurodegenerative dementia.

Areas Covered: Herein, the authors briefly review the DLB drug development pipeline, providing a summary of the current pharmacological intervention studies. They then focus on the anticonvulsant zonisamide, a benzisoxazole derivative with a sulfonamide group and look at its value for treating parkinsonism in DLB.

Expert Opinion: Several new compounds are being tested in DLB, the most innovative being those aimed at decreasing brain accumulation of α-synuclein. Unfortunately, new drug testing is challenging in terms of consistent diagnostic criteria and lack of reliable biomarkers. Few randomized controlled trials (RCTs) are well-designed, with enough power to detect significant drug effects. Levodopa monotherapy can treat the parkinsonism in DLB, but it can cause agitation or visual hallucination worsening. Two Phase II/III RCTs of DLB patients recently reported a statistically significant improvement in motor function in those receiving zonisamide as an adjunctive treatment to levodopa. New biomarker strategies and validated outcome measures for DLB or prodromal DLB may enhance clinical trial design for the development of specific disease-modifying treatments.
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http://dx.doi.org/10.1080/14656566.2020.1828350DOI Listing
February 2021

The relationship between epigenetics and microbiota in neuropsychiatric diseases.

Epigenomics 2020 09 9;12(17):1559-1568. Epub 2020 Sep 9.

Salus In Apulia Study: "Frailty Phenotypes Research Unit", National Institute of Gastroenterology "Saverio de Bellis", Research Hospital, Castellana Grotte Bari, Italy.

Microbiota might be considered as a pool for environmental epigenetic factors. Evidence is accumulating that environmental exposures - including microbes, diet, drugs - play a role in the pathogenesis of many neuropsychiatric disorders. Underlying mechanisms are complex, involving the sensitive interplay of genetics with epigenetics, neuroinflammation and the innate immune system. Modifications of microbiota affect neurogenesis and the maturation of microglia, influencing social behavior, stress-related responses and fear learning mechanisms. The excitatory neurons in the medial prefrontal cortex appear to play a key role. The mechanisms through which antibiotics administration may modulate microbiota and, therefore, behavior and neuropsychiatric disorders, may be influenced by several variables such as pre-existing gastrointestinal inflammation, the baseline microbiota composition, diet and stress perception. Probiotics, individualized diet, antibiotics and fecal transplantation could positively modulate the effects of epigenetic factors on neuropsychiatric disorders.
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http://dx.doi.org/10.2217/epi-2020-0053DOI Listing
September 2020

Liver fibrosis score, physical frailty, and the risk of dementia in older adults: The Italian Longitudinal Study on Aging.

Alzheimers Dement (N Y) 2020 24;6(1):e12065. Epub 2020 Aug 24.

Clinica Medica "Frugoni" and Geriatric Medicine-Memory Unit University of Bari Aldo Moro Bari Italy.

Introduction: Liver fibrosis increases progressively with aging and has been associated with poorer cognitive performance in middle-aged and older adults. We investigated the relationships between a non-invasive score for advanced liver fibrosis (non-alcoholic fatty liver disease [NAFLD] fibrosis score [NFS]) and dementia risk. We also assessed physical frailty, a common geriatric condition which is associated to dementia. We tested the joint effects of physical frailty and fibrosis on dementia incidence.

Methods: A total of 1061 older adults (65 to 84 years), from the Italian Longitudinal Study on Aging, were prospectively evaluated for the risk of dementia in a period between 1992 and 2001. Liver fibrosis was defined according to the NFS. Physical frailty was assessed according to the Fried's criteria. Cox proportional hazards models were used to estimate the short- and long-term risk of overall dementia, associated to the NFS, testing the effect modifier of physical frailty status.

Results: Older adults with only high NFS (F3-F4) did not exhibit a significant increased risk of overall dementia. Over 8 years of follow-up, frail older adults with high NFS had an increased risk of overall dementia (hazard ratio [HR]: 4.23; 95% confidence interval [CI]: 1.22 to 14.70,  = .023). Finally, physically frail older adults with low albumin serum levels (albumin < 4.3 g/dL) and with advanced liver fibrosis (F3-F4 NFS) compared to those with lower liver fibrosis score (F0-F2 NFS) were more likely to have a higher risk of overall dementia in a long term-period (HR: 16.42; 95% CI: 1.44 to 187.67,  = .024).

Discussion: Advanced liver fibrosis (F3-F4 NFS) could be a long-term predictor for overall dementia in people with physical frailty. These findings should encourage a typical geriatric, multidisciplinary assessment which accounts also for the possible co-presence of frail condition in older adults with chronic liver disease and liver fibrosis.
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http://dx.doi.org/10.1002/trc2.12065DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7443742PMC
August 2020

Nutritional domains in frailty tools: Working towards an operational definition of nutritional frailty.

Ageing Res Rev 2020 12 19;64:101148. Epub 2020 Aug 19.

Healthy Aging Phenotypes Research Unit, "Salus in Apulia Study", National Institute of Gastroenterology "Saverio de Bellis", Research Hospital, Castellana Grotte, Bari, Italy; Neurodegenerative Disease Unit, Department of Basic Medicine, Neuroscience, and Sense Organs, University of Bari Aldo Moro, Bari, Italy. Electronic address:

Different methods have been proposed for the assessment of the nutritional status in frailty phenotypes. In the present narrative review article, we have summarized the number and specifications of nutritional items in existing frailty tools, in order to develop a possible means of assessment and operational definition of the nutritional frailty phenotype. In six different databases until December 2019, we searched for original articles regarding frailty tools (i.e., scales, indexes, scores, questionnaires, instruments, evaluations, screening, indicators), analyzing each tool regarding nutritional items. We identified 160 articles describing 71 frailty tools. Among the selected frailty tools, 54 were community-based (70 %), 17 hospital-based (22 %), 4 validated in long-term care institutions for older adults (LTCIOA) (5.1 %) and 2 validated in both community- and hospital-based settings, including LTCIOA (2.5 %). Fifty-two of these tools (73 %) included at least one nutritional item. Twenty-two (42 %) reported two or more nutritional items. The items were grouped in the following categories: A) anthropometric measurements, B) laboratory measurements, and C) other nutritional-related measurements. Anthropometric measurements stood out compared to all other items. Nutritional items are included in the majority of frailty tools, strengthening the concept that they may have a direct implication on an increased risk of adverse health-related outcomes in frail subjects. This supports the development of the concept of nutritional frailty as an independent frailty phenotype. Subsequent steps will be to assess the contribution of each nutritional item to a possible operational definition of nutritional frailty and define the items that may best identify this new frailty phenotype.
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http://dx.doi.org/10.1016/j.arr.2020.101148DOI Listing
December 2020

Activity Energy Expenditure Predicts Clinical Average Levels of Physical Activity in Older Population: Results from Salus in Apulia Study.

Sensors (Basel) 2020 Aug 15;20(16). Epub 2020 Aug 15.

National Research Hospital, Population Health Unit-"Salus In Apulia Study"-National Institute of Gastroenterology "Saverio de Bellis", Research Hospital, Castellana Grotte, 70013 Bari, Italy.

Self-report questionnaires are a valuable method of physical activity measurement in public health research; however, accuracy is often lacking. Resolving the differences between self-reported and objectively measured physical activity is an important surveillance challenge currently facing population health experts. The present work aims at providing the relationship between activity energy expenditure estimated from wrist-worn accelerometers and intensity of self-reported physical activity (InCHIANTI structured interview questionnaire) in a sub-cohort of a population-based study on aging in Southern Italy. Linear regression was used to test the association between measured and reported physical activity. We found that activity energy expenditure predicted clinical average levels of PA assessed through InCHIANTI classification.
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http://dx.doi.org/10.3390/s20164585DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7472121PMC
August 2020

Age-related hearing loss and speech perception disorder: the broken interface between healthcare professionals and older adults.

Eur Geriatr Med 2020 12;11(6):893-895

Frailty Phenotypes Research Unit, "Salus in Apulia Study", National Institute of Gastroenterology "Saverio de Bellis", Research Hospital, Castellana Grotte, Bari, Italy.

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http://dx.doi.org/10.1007/s41999-020-00379-yDOI Listing
December 2020

Anti-amyloid-β protein agents for the treatment of Alzheimer's disease: an update on emerging drugs.

Expert Opin Emerg Drugs 2020 09 20;25(3):319-335. Epub 2020 Aug 20.

Population Health Unit - "Salus in Apulia Study" - National Institute of Gastroenterology, "Saverio De Bellis", Research Hospital , Bari, Italy.

Introduction: Currently available Alzheimer's disease (AD) therapeutics are only symptomatic, targeting cholinergic and glutamatergic neurotransmissions. Several putative disease-modifying drugs in late-stage clinical development target amyloid-β (Aβ) peptide and tau protein, the principal neurophatological hallmarks of the disease.

Areas Covered: Phase III randomized clinical trials of anti-Aβ drugs for AD treatment were searched in US and EU clinical trial registries and principal biomedical databases until May 2020.

Expert Opinion: At present, compounds in Phase III clinical development for AD include four  anti-Ab monoclonal antibodies (solanezumab, gantenerumab, aducanumab, BAN2401), the combination of cromolyn sodium and ibuprofen (ALZT-OP1), and two small molecules (levetiracetam, GV-971). These drugs are mainly being tested in subjects during early AD phases or at preclinical stage of familial AD or even in asymptomatic subjects at high risk of developing AD. The actual results support the hypothesis that elevated Aβ represents an early stage in the AD continuum and demonstrate the feasibility of enrolling these high-risk participants in secondary prevention trials to slow cognitive decline during the AD preclinical stages. However, a series of clinical failures may question further development of Aβ-targeting drugs and the findings from current ongoing Phase III trials will hopefully give light to this critical issue.
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http://dx.doi.org/10.1080/14728214.2020.1808621DOI Listing
September 2020

Age-related hearing loss and neuropathologic burden: A step inside the cognitive ear.

Neurology 2020 09 5;95(12):511-512. Epub 2020 Aug 5.

From the Neurodegenerative Disease Unit (M.L.), Department of Basic Medicine, Neuroscience, and Sense Organs, University of Bari Aldo Moro; and Frailty Phenotypes Research Unit (R.S., F.P.), "Salus in Apulia Study," National Institute of Gastroenterology "Saverio de Bellis," Research Hospital, Bari, Italy.

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http://dx.doi.org/10.1212/WNL.0000000000010580DOI Listing
September 2020

Discontinued disease-modifying therapies for Alzheimer's disease: status and future perspectives.

Expert Opin Investig Drugs 2020 Sep 26;29(9):919-933. Epub 2020 Jul 26.

Unit of Epidemiological Research on Aging "Greatage Study", National Institute of Gastroenterology and Research Hospital IRCCS "S. de Bellis" , Bari, Italy.

Introduction: Alzheimer's disease (AD) is the main cause of dementia and represents a huge burden for patients, carers, and healthcare systems. Extensive efforts for over 20 years have failed to find effective disease-modifying drugs. Although amyloid-β (Aβ) accumulation in the brain predicts cognitive decline, effective reduction of plaque load by numerous drug candidates has not yielded significant clinical benefits. A similar pattern is now emerging for drugs which target hyperphosphorylated tau, and trials with anti-inflammatory drugs have been negative despite neuroinflammation appearing to have a crucial role in AD pathogenesis.

Areas Covered: This article reviews key drugs that have been discontinued while in development for AD and delineates the future landscape for present and alternative approaches.

Expert Opinion: Anti-Aβ drugs have failed to validate the Aβ cascade hypothesis of AD. Early findings suggest that the same is happening with therapeutics targeting tau and focussing future research solely on anti-tau drugs is inappropriate. Alternative targets should be pursued, including apolipoprotein E, immunomodulation, plasma exchange, protein autophagy and clearance, mitochondrial dysfunction, abnormal glucose metabolism, neurovascular unit support, epigenetic dysregulation, synaptic loss and dysfunction, microbiota dysbiosis, and combination therapies. Meanwhile, repurposing of drugs approved for other indications is justified where scientific rationale and robust preclinical evidence exist.
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http://dx.doi.org/10.1080/13543784.2020.1795127DOI Listing
September 2020
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