Publications by authors named "Irene Richard"

42 Publications

The Importance of Cross-Disciplinary Research: A Commentary on "Brainstem Pathologies Correlate With Depression and Psychosis in Parkinson's Disease".

Am J Geriatr Psychiatry 2021 09 19;29(9):969-971. Epub 2021 Jan 19.

Department of Neurology (RBS, IHR), University of Rochester, Rochester, NY.

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http://dx.doi.org/10.1016/j.jagp.2021.01.010DOI Listing
September 2021

A trial of buspirone for anxiety in Parkinson's disease: Safety and tolerability.

Parkinsonism Relat Disord 2020 12 13;81:69-74. Epub 2020 Oct 13.

Department of Neurology, University of Rochester School of Medicine and Dentistry, 919 Westfall Rd, Building C, Suite 100, Rochester, NY, 14618, USA. Electronic address:

Introduction: In Parkinson's disease (PD), anxiety is common, associated with lower health-related quality of life, and undertreated. The primary objective of this study was to determine the tolerability of buspirone for the treatment of anxiety in PD.

Methods: Individuals with PD and clinically significant anxiety were randomized 4:1 to flexible dosage buspirone or placebo for 12 weeks. Treatment was initiated at 7.5 mg twice daily and titrated based on response and tolerability to an optimal dosage (maximum 30 mg twice daily). The primary outcome was the proportion of participants who failed to complete the study on study drug. Secondary outcomes included adverse events, dosage reductions, motor function, dyskinesias, and anxiety.

Results: A total of 21 participants enrolled, 4 were randomized to placebo and 17 to buspirone (mean (SD) age 65.5 (9.8), 76.5% male, 88% on concomitant antidepressant or anxiolytic). In the buspirone group, 7 (41%) failed to complete the study on drug, 5 due to intolerability. The median buspirone dosage was 7.5 mg twice daily. No serious adverse events occurred. A total of 9 (53%) buspirone participants experienced adverse events consistent with worsened motor function. In the buspirone group, mean (SD) improvement from baseline to week 12 in Hamilton Anxiety Rating Scale was -3.9 (3.8) and Parkinson Anxiety Scale -7.1 (6.4).

Conclusion: Tolerability concerns do not support moving immediately forward with a large-scale efficacy trial. However, concomitant anxiolytics may have affected tolerability and a signal of efficacy was seen suggesting that future studies of buspirone monotherapy be considered.
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http://dx.doi.org/10.1016/j.parkreldis.2020.10.020DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7770052PMC
December 2020

Neuropsychiatric symptoms and cognitive abilities over the initial quinquennium of Parkinson disease.

Ann Clin Transl Neurol 2020 04 13;7(4):449-461. Epub 2020 Apr 13.

Departments of Neurology and Psychiatry & Behavioral Sciences, Baylor College of Medicine, Houston, Texas.

Objective: To determine the evolution of numerous neuropsychiatric symptoms and cognitive abilities in Parkinson disease from disease onset.

Methods: Prospectively collected, longitudinal (untreated, disease onset to year 5), observational data from Parkinson's Progression Markers Initiative annual visits was used to evaluate prevalence, correlates, and treatment of 10 neuropsychiatric symptoms and cognitive impairment in Parkinson disease participants and matched healthy controls.

Results: Of 423 Parkinson disease participants evaluated at baseline, 315 (74.5%) were assessed at year 5. Eight neuropsychiatric symptoms studied increased in absolute prevalence by 6.2-20.9% at year 5 relative to baseline, and cognitive impairment increased by 2.7-6.2%. In comparison, the frequency of neuropsychiatric symptoms in healthy controls remained stable or declined over time. Antidepressant and anxiolytic/hypnotic use in Parkinson disease were common at baseline and increased over time (18% to 27% for the former; 13% to 24% for the latter); antipsychotic and cognitive-enhancing medication use was uncommon throughout (2% and 5% of patients at year 5); and potentially harmful anticholinergic medication use was common and increased over time. At year 5 the cross-sectional prevalence for having three or more neuropsychiatric disorders/cognitive impairment was 56% for Parkinson disease participants versus 13% for healthy controls, and by then seven of the examined disorders had either occurred or been treated at some time point in the majority of Parkinson disease patients. Principal component analysis suggested an affective disorder subtype only.

Interpretation: Neuropsychiatric features in Parkinson disease are common from the onset, increase over time, are frequently comorbid, and fluctuate in severity.
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http://dx.doi.org/10.1002/acn3.51022DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7187707PMC
April 2020

Report from a multidisciplinary meeting on anxiety as a non-motor manifestation of Parkinson's disease.

NPJ Parkinsons Dis 2019 11;5:30. Epub 2019 Dec 11.

24Cleveland Clinic Lou Ruvo Center for Brain Health, Movement Disorders Program, Las Vegas, NV USA.

Anxiety is a severe problem for at least one-third of people living with Parkinson's disease (PD). Anxiety appears to have a greater adverse impact on quality of life than motor impairment. Despite its high prevalence and impact on daily life, anxiety is often undiagnosed and untreated. To better address anxiety in PD, future research must improve knowledge about the mechanism of anxiety in PD and address the lack of empirical evidence from clinical trials. In response to these challenges, the Parkinson's Foundation sponsored an expert meeting on anxiety on June 13th and 14th 2018. This paper summarizes the findings from that meeting informed by a review of the existing literature and discussions among patients, caregivers, and an international, clinician-scientist, expert panel working group. The goal is to provide recommendations to improve our understanding and treatment of anxiety in PD.
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http://dx.doi.org/10.1038/s41531-019-0102-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6906437PMC
December 2019

Lewy Body Dementia Association's Research Centers of Excellence Program: Inaugural Meeting Proceedings.

Alzheimers Res Ther 2019 03 13;11(1):23. Epub 2019 Mar 13.

Johns Hopkins University, Baltimore, USA.

The first Lewy Body Dementia Association (LBDA) Research Centers of Excellence (RCOE) Investigator's meeting was held on December 14, 2017, in New Orleans. The program was established to increase patient access to clinical experts on Lewy body dementia (LBD), which includes dementia with Lewy bodies (DLB) and Parkinson's disease dementia (PDD), and to create a clinical trials-ready network. Four working groups (WG) were created to pursue the LBDA RCOE aims: (1) increase access to high-quality clinical care, (2) increase access to support for people living with LBD and their caregivers, (3) increase knowledge of LBD among medical and allied (or other) professionals, and (4) create infrastructure for a clinical trials-ready network as well as resources to advance the study of new therapeutics.
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http://dx.doi.org/10.1186/s13195-019-0476-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6417280PMC
March 2019

Cognition among individuals along a spectrum of increased risk for Parkinson's disease.

PLoS One 2018 20;13(8):e0201964. Epub 2018 Aug 20.

Department of Psychiatry, University of Pennsylvania School of Medicine, Philadelphia, PA, United States of America.

Introduction: Several characteristics associated with increased risk for Parkinson's disease (PD) have been identified, including specific genotypes and various non-motor symptoms. Characterizing non-motor features, such as cognitive abilities, among individuals considered at-risk for PD is essential to improving prediction of future neurodegeneration.

Methods: Participants belonging to the following cohorts of the Parkinson Progression Markers Initiative (PPMI) study were included: de novo PD with dopamine transporter binding deficit (n = 423), idiopathic REM sleep behavior disorder (RBD, n = 39), hyposmia (n = 26) and non-PD mutation carrier (NMC; Leucine-rich repeat kinase 2 (LRRK2) G2019S (n = 88) and glucocerebrosidase (GBA) gene (n = 38) mutations)). Inclusion criteria enriched the RBD and hyposmia cohorts, but not the NMC cohort, with individuals with dopamine transporter binding deficit. Baseline neuropsychological performance was compared, and analyses were adjusted for age, sex, education, and depression.

Results: The RBD cohort performed significantly worse than the hyposmia and NMC cohorts on Symbol Digit Modality Test (mean (SD) 32.4 (9.16) vs. 41.8 (9.98), p = 0.002 and vs. 45.2 (10.9), p<0.001) and Judgment of Line Orientation (11.3 (2.36) vs.12.9 (1.87), p = 0.004 and vs. 12.9 (1.87), p<0.001). The RBD cohort also performed worse than the hyposmia cohort on the Montreal Cognitive Assessment (25.5 (4.13) vs. 27.3 (1.71), p = 0.02). Hyposmics did not differ from PD or NMC cohorts on any cognitive test score.

Conclusion: Among individuals across a spectrum of risk for PD, cognitive function is worse among those with the characteristic most strongly associated with future risk of PD or dementia with Lewy bodies, namely RBD.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0201964PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6101368PMC
February 2019

Parkinson's disease psychosis: presentation, diagnosis and management.

Neurodegener Dis Manag 2017 Dec 21;7(6):365-376. Epub 2017 Nov 21.

Department of Neurology, University of Rochester School of Medicine & Dentistry, 919 Westfall Rd, Bldg C, Rochester, NY 14618, USA.

Parkinson's disease is a neurodegenerative disorder characterized by motor and nonmotor symptoms. Psychosis is a common feature of Parkinson's disease. Parkinson's disease psychosis (PDP) encompasses minor phenomena (illusions, passage hallucinations and presence hallucinations), visual and nonvisual hallucinations and delusions. PDP is associated with reduced function and quality of life. The initial management approach should focus on identification and treatment of any contributory medical factors, reduction or discontinuation of medications with potential to induce or worsen psychosis, nonpharmacological strategies and consideration of acetylcholinesterase inhibitor treatment in the setting of dementia. Pimavanserin, quetiapine and clozapine may all be considered for use in PDP. In this review, we discuss the presentation, diagnosis and management of PDP.
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http://dx.doi.org/10.2217/nmt-2017-0028DOI Listing
December 2017

Virtual visits for Parkinson disease: A multicenter noncontrolled cohort.

Neurol Clin Pract 2017 08;7(4):283-295

University of Rochester School of Medicine and Dentistry (REK, HTK); Center for Human Experimental Therapeutics (REK, HTK, SG, PA, WZ, MAA, ERD, KMB) and Department of Neurology (PA, RB, IR, KLA, HBS, ERD, KMB, SK), University of Rochester, NY; Center for Movement Disorders and Neurorestoration (AWS, KR), Department of Neurology, University of Florida, Gainesville; Department of Neurology (MK, MD, EB, CMT, NBG), University of California-San Francisco; Parkinson's Disease Research, Education and Clinical Center (MK, MD, EB, CMT, NBG), San Francisco Veterans Affairs Medical Center, CA; University of Michigan Medical School (WZ), Ann Arbor; Department of Neurology (KLA), University at Buffalo, NY; Neurology Private Practice (GK), Berkeley, CA; and Department of Internal Medicine (RR), University of Central Florida College of Medicine, Orlando, FL.

Background: Previous small-scale studies have demonstrated the feasibility of providing remote specialty care via virtual visits. We assessed the feasibility and benefits of a one-time consultation between a remote Parkinson Disease (PD) specialist and an individual with PD at home on a larger scale.

Methods: We conducted a multicenter noncontrolled cohort of virtual visits administered over videoconferencing between remote PD specialists and individuals with PD in their home. Specialists performed a patient history and a PD-specific physical examination and provided recommendations to patients and their local physicians. The primary outcome measures were feasibility, as measured by the proportion of visits completed as scheduled, and the 6-month change in quality of life, as measured by the Parkinson's Disease Questionnaire 39. Additional outcomes included satisfaction with visits and interest in future virtual visits.

Results: A total of 277 participants from 5 states enrolled, 258 participants completed virtual visits with 14 different physicians, and 91% of visits were completed as scheduled. No improvement in quality of life was observed at 6 months (0.4-point improvement; 95% confidence interval -1.5 to 0.6; = 0.39). Overall satisfaction with virtual visits was high among physicians (94% satisfied or very satisfied) and patients (94% satisfied or very satisfied), and 74% of participants were interested in receiving future care via virtual visits.

Conclusions: Providing specialty care remotely into the homes of individuals with PD is feasible, but a one-time visit did not improve quality of life. Satisfaction with the visits was high among physicians and patients, who were interested in receiving such care in the future.

Classification Of Evidence: This study provides Class IV evidence that for patients with PD, remote specialty care is feasible but does not improve quality of life.

Clinicaltrialsgov Identifier: NCT02144220.
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http://dx.doi.org/10.1212/CPJ.0000000000000371DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5566796PMC
August 2017

National randomized controlled trial of virtual house calls for Parkinson disease.

Neurology 2017 Sep 16;89(11):1152-1161. Epub 2017 Aug 16.

From the Department of Biostatistics and Computational Biology (C.A.B.), University of Rochester, NY; National Parkinson Foundation (D.B.B., P.N.S.), Miami, FL; Department of Neurology (K.M.B., E.R.D., I.H.R., H.S.) and The Center for Human Experimental Therapeutics (E.R.D., M.A.A., M.J.E., S.G., H.T.K., R.K., S.S., E.A.S., W.Z.), University of Rochester Medical Center, NY; Division of Geriatric Medicine and Gerontology, Department of Medicine (C.M.B., Z.M., B.D.), Johns Hopkins University School of Medicine, Baltimore, MD; Simone Consulting (R.S.), Sunnyvale, CA; Departments of Neurology and Biostatistics and Epidemiology (A.W.W., M.S., S.R.), University of Pennsylvania Perelman School of Medicine, Philadelphia; University of California San Francisco (N.B.G., M.K., C.M.T., K.D.); Northwest Neurological, PLLC (J. Aldred), Spokane, WA; Oregon Health and Science University (J.C., A. Fraser), Portland; Baylor College of Medicine (J.J.-S., C.H.), Houston, TX; Augusta University (J.C.M., D.M.), GA; Duke Medical Center (P.H., L.G.), Durham, NC; Massachusetts General Hospital (N.I.M., G.B.), Boston; Struthers Parkinson's Center (M.N.), Minneapolis, MN; Beth Israel Deaconess Medical Center (L.C.S.), Boston, MA; University of Miami (C.S., S.V.-P.), FL; Northwestern University (C.Z., N.O.), Evanston, IL; The Feinstein Institute for Medical Research (A. Feigin, J. Ayan), Northwell Health, Manhasset, NY; Medical University of South Carolina (C.V.), Charleston; University of Kansas Medical Center (R.P.), Kansas City; Parkinson's Institute (R.D.), Sunnyvale, CA; Mayo Clinic (A.H.), Rochester, MN; Center for Information Technology Research in the Interest of Society (CITRIS) (S.D.), University of California, Berkeley; Health Informatics Centre (S.S.R.), Karolinska Institute, Stockholm, Sweden; and PatientsLikeMe (P.W.), Derby, UK.

Objective: To determine whether providing remote neurologic care into the homes of people with Parkinson disease (PD) is feasible, beneficial, and valuable.

Methods: In a 1-year randomized controlled trial, we compared usual care to usual care supplemented by 4 virtual visits via video conferencing from a remote specialist into patients' homes. Primary outcome measures were feasibility, as measured by the proportion who completed at least one virtual visit and the proportion of virtual visits completed on time; and efficacy, as measured by the change in the Parkinson's Disease Questionnaire-39, a quality of life scale. Secondary outcomes included quality of care, caregiver burden, and time and travel savings.

Results: A total of 927 individuals indicated interest, 210 were enrolled, and 195 were randomized. Participants had recently seen a specialist (73%) and were largely college-educated (73%) and white (96%). Ninety-five (98% of the intervention group) completed at least one virtual visit, and 91% of 388 virtual visits were completed. Quality of life did not improve in those receiving virtual house calls (0.3 points worse on a 100-point scale; 95% confidence interval [CI] -2.0 to 2.7 points; = 0.78) nor did quality of care or caregiver burden. Each virtual house call saved patients a median of 88 minutes (95% CI 70-120; < 0.0001) and 38 miles per visit (95% CI 36-56; < 0.0001).

Conclusions: Providing remote neurologic care directly into the homes of people with PD was feasible and was neither more nor less efficacious than usual in-person care. Virtual house calls generated great interest and provided substantial convenience.

Clinicaltrialsgov Identifier: NCT02038959.

Classification Of Evidence: This study provides Class III evidence that for patients with PD, virtual house calls from a neurologist are feasible and do not significantly change quality of life compared to in-person visits. The study is rated Class III because it was not possible to mask patients to visit type.
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http://dx.doi.org/10.1212/WNL.0000000000004357DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5595275PMC
September 2017

Multiple modality biomarker prediction of cognitive impairment in prospectively followed de novo Parkinson disease.

PLoS One 2017 17;12(5):e0175674. Epub 2017 May 17.

Department of Neurology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, United States of America.

Objectives: To assess the neurobiological substrate of initial cognitive decline in Parkinson's disease (PD) to inform patient management, clinical trial design, and development of treatments.

Methods: We longitudinally assessed, up to 3 years, 423 newly diagnosed patients with idiopathic PD, untreated at baseline, from 33 international movement disorder centers. Study outcomes were four determinations of cognitive impairment or decline, and biomarker predictors were baseline dopamine transporter (DAT) single photon emission computed tomography (SPECT) scan, structural magnetic resonance imaging (MRI; volume and thickness), diffusion tensor imaging (mean diffusivity and fractional anisotropy), cerebrospinal fluid (CSF; amyloid beta [Aβ], tau and alpha synuclein), and 11 single nucleotide polymorphisms (SNPs) previously associated with PD cognition. Additionally, longitudinal structural MRI and DAT scan data were included. Univariate analyses were run initially, with false discovery rate = 0.2, to select biomarker variables for inclusion in multivariable longitudinal mixed-effect models.

Results: By year 3, cognitive impairment was diagnosed in 15-38% participants depending on the criteria applied. Biomarkers, some longitudinal, predicting cognitive impairment in multivariable models were: (1) dopamine deficiency (decreased caudate and putamen DAT availability); (2) diffuse, cortical decreased brain volume or thickness (frontal, temporal, parietal, and occipital lobe regions); (3) co-morbid Alzheimer's disease Aβ amyloid pathology (lower CSF Aβ 1-42); and (4) genes (COMT val/val and BDNF val/val genotypes).

Conclusions: Cognitive impairment in PD increases in frequency 50-200% in the first several years of disease, and is independently predicted by biomarker changes related to nigrostriatal or cortical dopaminergic deficits, global atrophy due to possible widespread effects of neurodegenerative disease, co-morbid Alzheimer's disease plaque pathology, and genetic factors.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0175674PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5435130PMC
September 2017

Long-term follow-up of a randomized AAV2- gene therapy trial for Parkinson's disease.

JCI Insight 2017 04 6;2(7):e90133. Epub 2017 Apr 6.

Center for Neurosciences, The Feinstein Institute for Medical Research, Manhasset, New York, USA.

We report the 12-month clinical and imaging data on the effects of bilateral delivery of the glutamic acid decarboxylase gene into the subthalamic nuclei (STN) of advanced Parkinson's disease (PD) patients. 45 PD patients were enrolled in a 6-month double-blind randomized trial of bilateral AAV2- delivery into the STN compared with sham surgery and were followed for 12 months in open-label fashion. Subjects were assessed with clinical outcome measures and F-fluorodeoxyglucose (FDG) PET imaging. Improvements under the blind in Unified Parkinson's Disease Rating Scale (UPDRS) motor scores in the AAV2- group compared with the sham group continued at 12 months [time effect: (4,138) = 11.55, < 0.001; group effect: (1,35) = 5.45, < 0.03; repeated-measures ANOVA (RMANOVA)]. Daily duration of levodopa-induced dyskinesias significantly declined at 12 months in the AAV2- group ( = 0.03; post-hoc Bonferroni test), while the sham group was unchanged. Analysis of all FDG PET images over 12 months revealed significant metabolic declines ( < 0.001; statistical parametric mapping RMANOVA) in the thalamus, striatum, and prefrontal, anterior cingulate, and orbitofrontal cortices in the AAV2- group compared with the sham group. Across all time points, changes in regional metabolism differed for the two groups in all areas, with significant declines only in the AAV2- group ( < 0.005; post-hoc Bonferroni tests). Furthermore, baseline metabolism in the prefrontal cortex (PFC) correlated with changes in motor UPDRS scores; the higher the baseline PFC metabolism, the better the clinical outcome. These findings show that clinical benefits after gene therapy with STN AAV2- in PD patients persist at 12 months. ClinicalTrials.gov NCT00643890. Neurologix Inc.
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http://dx.doi.org/10.1172/jci.insight.90133DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5374069PMC
April 2017

National Randomized Controlled Trial of Virtual House Calls for People with Parkinson's Disease: Interest and Barriers.

Telemed J E Health 2016 07 17;22(7):590-8. Epub 2016 Feb 17.

19 Department of Neurology, Beth Israel Deaconess Medical Center , Boston, Massachusetts.

Background: Delivering specialty care remotely directly into people's homes can enhance access for and improve the healthcare of individuals with chronic conditions. However, evidence supporting this approach is limited.

Materials And Methods: Connect.Parkinson is a randomized comparative effectiveness study that compares usual care of individuals with Parkinson's disease in the community with usual care augmented by virtual house calls with a Parkinson's disease specialist from 1 of 18 centers nationally. Individuals in the intervention arm receive four virtual visits from a Parkinson's disease specialist over 1 year via secure, Web-based videoconferencing directly into their homes. All study activities, including recruitment, enrollment, and assessments, are conducted remotely. Here we report on interest, feasibility, and barriers to enrollment in this ongoing study.

Results: During recruitment, 11,734 individuals visited the study's Web site, and 927 unique individuals submitted electronic interest forms. Two hundred ten individuals from 18 states enrolled in the study from March 2014 to June 2015, and 195 were randomized. Most participants were white (96%) and college educated (73%). Of the randomized participants, 73% had seen a Parkinson's disease specialist within the previous year.

Conclusions: Among individuals with Parkinson's disease, national interest in receiving remote specialty care directly into the home is high. Remote enrollment in this care model is feasible but is likely affected by differential access to the Internet.
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http://dx.doi.org/10.1089/tmj.2015.0191DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4939367PMC
July 2016

Modeling anxiety in Parkinson's disease.

Mov Disord 2016 Mar 21;31(3):310-6. Epub 2015 Dec 21.

Department of Psychiatry and Neuropsychology, School for Mental Health and Neuroscience, Alzheimer Center Limburg, Maastricht University Medical Center, Maastricht, The Netherlands.

Background: The aim of this work was to construct a model for anxiety in PD and compare the relative contributions of PD-specific and -nonspecific general population risk factors for anxiety in this model.

Methods: Structural equation modeling of associations of risk factors with the anxiety outcome using a cross-sectional data set of 342 patients with PD were used.

Results: A model with acceptable to good fit was generated that explained 65% of the variance in anxiety scores. A previous history of depression and the severity of the depressive symptoms scored on the Hamilton Depression Rating Scale were the only nonspecific variables with a direct effect on anxiety. The presence of motor fluctuations and disease-related decline in activities of daily living were PD-specific markers of anxiety. Nonspecific risk factors had a greater influence in the model than PD-specific risk factors. Standardized regression coefficients suggested that the Hamilton Depression Rating Scale score was the most important contributor to the variation in anxiety. A post-hoc analysis showed that the effects of the following variables on anxiety levels were fully mediated by depression: sex; family history of depression; previous history of anxiety; cognitive status; difficulties in non-disease-specific activities of daily living; and severity of motor signs.

Conclusion: In this cross-sectional study, we showed that nonspecific general population risk factors are more important markers for anxiety than PD-specific risk factors. Depression was the most prominent marker. PD-specific markers for anxiety appear to be more situational and related to off periods and disease-specific disturbances of activities of daily living.
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http://dx.doi.org/10.1002/mds.26461DOI Listing
March 2016

Feasibility of Virtual Research Visits in Fox Trial Finder.

J Parkinsons Dis 2015 ;5(3):505-15

Department of Neurology, University of Rochester Medical Center, Rochester, New York, United States.

Background: Fox Trial Finder is an online registry for individuals with and without Parkinson disease (PD) interested in participating in PD research. However, distance or disability could prevent such individuals from participating in traditional, clinic-based research at major centers.

Objective: Use videoconferencing to connect participants to specialists to: (1) demonstrate feasibility of virtual research visits within this population (2) collect phenotypic data of the participants, (3) validate self-reported diagnosis, and (4) gauge interest in virtual research visits.

Methods: We solicited volunteers throughout the United States through Fox Trial Finder. Interested individuals with PD provided consent, were given web cameras if needed, completed baseline surveys, and downloaded videoconferencing software remotely. Participants had a test connection and assessment appointment which included the Montreal Cognitive Assessment (MoCA), then a virtual research visit with a neurologist who reviewed their history and assessed their PD using a modified Movement Disorders Society Unified Parkinson's Disease Rating Scale. Neurologists assessed PD diagnosis and symptomatology. Physicians and participants were surveyed about their experience.

Results: Of 204 individuals who consented, 166 (81% ) individuals from 39 states completed all visits. The mean age was 62 and mean disease duration was 8.0 years. Mean MoCA score was 26.5, and mean modified MDS-UPDRS motor score was 22.8 (out of a possible 124). Neurologists judged PD as the most likely diagnosis in 97% of cases. Overall satisfaction with the visits was 79% (satisfied or very satisfied) among neurologists and 93% among participants.

Conclusions: Through virtual research visits, neurologists engaged, characterized, and validated self-reported diagnosis in individuals with PD over a broad geography. This model may facilitate future research participation.
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http://dx.doi.org/10.3233/JPD-150549DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4923707PMC
July 2016

Cognitive performance and neuropsychiatric symptoms in early, untreated Parkinson's disease.

Mov Disord 2015 Jun 4;30(7):919-27. Epub 2015 Mar 4.

Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut, USA.

Unlabelled: This study was undertaken to determine the prevalence and correlates of cognitive impairment (CI) and neuropsychiatric symptoms (NPS) in early, untreated patients with Parkinson's disease (PD).

Background: Both CI and NPS are common in PD and impact disease course and quality of life. However, limited knowledge is available about cognitive abilities and NPS.

Methods: Parkinson's Progression Markers Initiative (PPMI) is a multi-site study of early, untreated PD patients and healthy controls (HCs), the latter with normal cognition. At baseline, participants were assessed with a neuropsychological battery and for symptoms of depression, anxiety, impulse control disorders (ICDs), psychosis, and apathy.

Results: Baseline data of 423 PD patients and 196 HCs yielded no between-group differences in demographic characteristics. Twenty-two percent of PD patients met the PD-recommended screening cutoff for CI on the Montral Cognitive Assessment (MoCA), but only 9% met detailed neuropsychological testing criteria for mild cognitive impairment (MCI)-level impairment. The PD patients were more depressed than HCs (P < 0.001), with twice as many (14% vs. 7%) meeting criteria for clinically significant depressive symptoms. The PD patients also experienced more anxiety (P < 0.001) and apathy (P < 0.001) than HCs. Psychosis was uncommon in PD (3%), and no between-group difference was seen in ICD symptoms (P = 0.51).

Conclusions: Approximately 10% of PD patients in the early, untreated disease state met traditional criteria of CI, which is a lower frequency compared with previous studies. Multiple dopaminergic-dependent NPS are also more common in these patients compared with the general population, but others associated with dopamine replacement therapy are not or are rare. Future analyses of this cohort will examine biological predictors and the course of CI and NPS. © 2015 International Parkinson and Movement Disorder Society.
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http://dx.doi.org/10.1002/mds.26170DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4855523PMC
June 2015

Managing depression in Parkinson's patients: risk factors and clinical pearls.

Neurodegener Dis Manag 2014 ;4(4):329-36

University of Rochester, Rochester, NY, USA.

Parkinson's disease (PD) is a neurodegenerative condition that is on the rise as the world's population ages. As our understanding of the disease increases, depression has emerged as a common syndrome in this population that significantly reduces quality of life, making its understanding, recognition and treatment an important area of focus for clinicians and researchers alike. It is hypothesized that depression is a consequence of the disease process itself, sometimes developing prior to the onset of motor symptoms. Many of the diagnostic tools and treatments for depression have not been fully evaluated in the PD population. However, several traditional diagnostic interviews and depression rating scales have been used in recent clinical trials. These study results suggest that some of the currently available antidepressant medications may be effective and well tolerated in this population. This paper reviews our understanding of depression in PD as well as the current recommendations for its diagnosis and treatment.
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http://dx.doi.org/10.2217/nmt.14.31DOI Listing
April 2015

A randomized clinical trial of high-dosage coenzyme Q10 in early Parkinson disease: no evidence of benefit.

JAMA Neurol 2014 May;71(5):543-52

Columbia University Medical Center, Neurological Institute, New York, New York.

Importance: Coenzyme Q10 (CoQ10), an antioxidant that supports mitochondrial function, has been shown in preclinical Parkinson disease (PD) models to reduce the loss of dopamine neurons, and was safe and well tolerated in early-phase human studies. A previous phase II study suggested possible clinical benefit.

Objective: To examine whether CoQ10 could slow disease progression in early PD.

Design, Setting, And Participants: A phase III randomized, placebo-controlled, double-blind clinical trial at 67 North American sites consisting of participants 30 years of age or older who received a diagnosis of PD within 5 years and who had the following inclusion criteria: the presence of a rest tremor, bradykinesia, and rigidity; a modified Hoehn and Yahr stage of 2.5 or less; and no anticipated need for dopaminergic therapy within 3 months. Exclusion criteria included the use of any PD medication within 60 days, the use of any symptomatic PD medication for more than 90 days, atypical or drug-induced parkinsonism, a Unified Parkinson's Disease Rating Scale (UPDRS) rest tremor score of 3 or greater for any limb, a Mini-Mental State Examination score of 25 or less, a history of stroke, the use of certain supplements, and substantial recent exposure to CoQ10. Of 696 participants screened, 78 were found to be ineligible, and 18 declined participation.

Interventions: The remaining 600 participants were randomly assigned to receive placebo, 1200 mg/d of CoQ10, or 2400 mg/d of CoQ10; all participants received 1200 IU/d of vitamin E.

Main Outcomes And Measures: Participants were observed for 16 months or until a disability requiring dopaminergic treatment. The prospectively defined primary outcome measure was the change in total UPDRS score (Parts I-III) from baseline to final visit. The study was powered to detect a 3-point difference between an active treatment and placebo.

Results: The baseline characteristics of the participants were well balanced, the mean age was 62.5 years, 66% of participants were male, and the mean baseline total UPDRS score was 22.7. A total of 267 participants required treatment (94 received placebo, 87 received 1200 mg/d of CoQ10, and 86 received 2400 mg/d of CoQ10), and 65 participants (29 who received placebo, 19 who received 1200 mg/d of CoQ10, and 17 who received 2400 mg/d of CoQ10) withdrew prematurely. Treatments were well tolerated with no safety concerns. The study was terminated after a prespecified futility criterion was reached. At study termination, both active treatment groups showed slight adverse trends relative to placebo. Adjusted mean changes (worsening) in total UPDRS scores from baseline to final visit were 6.9 points (placebo), 7.5 points (1200 mg/d of CoQ10; P = .49 relative to placebo), and 8.0 points (2400 mg/d of CoQ10; P = .21 relative to placebo).

Conclusions And Relevance: Coenzyme Q10 was safe and well tolerated in this population, but showed no evidence of clinical benefit.

Trial Registration: clinicaltrials.gov Identifier: NCT00740714.
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http://dx.doi.org/10.1001/jamaneurol.2014.131DOI Listing
May 2014

Anxiety has specific syndromal profiles in Parkinson disease: a data-driven approach.

Am J Geriatr Psychiatry 2014 Dec 5;22(12):1410-7. Epub 2013 Nov 5.

Department of Psychiatry, Maastricht University Medical Centre, Maastricht, The Netherlands.

Background: Anxiety symptoms are common in Parkinson disease (PD). Recent evidence suggests that anxiety syndromes as encountered in clinical practice may not correspond to the DSM-IV classification of anxiety disorders.

Objective: To examine the syndromal pattern of the anxiety spectrum in a large series of patients with PD, as determined with a data-driven approach using latent class analysis (LCA).

Methods: 342 patients with PD were recruited from referrals to movement disorders or psychiatry clinics at six tertiary centers. Participants were assessed with a structured psychiatric interview and specific scales rating the severity of anxiety, depression, cognition and parkinsonism. The main outcome measure was classes of patients with a specific syndromal profile of anxiety symptoms based on LCA.

Results: LCA identified four classes that were interpreted as "no anxiety or depression", "episodic anxiety without depression", "persistent anxiety with depression", and "both persistent and episodic anxiety with depression". Symptoms of persistent anxiety were almost invariably associated with symptoms of depression. There were significant differences between classes in terms of history of depression and anxiety, use of psychoactive medication, and on the Mentation and Complications sections of the Unified Parkinson Disease Rating Scale.

Conclusions: Patients with PD show different syndromic profiles of anxiety that do not align with the symptom profiles represented by DSM-IV anxiety disorders and major depression. Accordingly, DSM-IV criteria for anxiety disorders may not be clinically useful in PD. The different classes identified here provide empirically validated phenotypes for future research.
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http://dx.doi.org/10.1016/j.jagp.2013.09.006DOI Listing
December 2014

Modeling depression in Parkinson disease: disease-specific and nonspecific risk factors.

Neurology 2013 Sep 14;81(12):1036-43. Epub 2013 Aug 14.

From the Department of Psychiatry (A.F.G.L., A.J.H.M.), Maastricht University Medical Center, Maastricht; School for Mental Health and Neuroscience (A.F.G.L., A.J.H.M., S.K.), Maastricht University, Maastricht, the Netherlands; Neurology and Movement Disorders Unit (K.D.), Lille University Medical Center, Lille, France; Mental Health Care Line (L.M.), Michael E. DeBakey Veterans Administration Medical Center and Departments of Psychiatry and Neurology, Baylor College of Medicine, Houston, TX; Alzheimer Disease Research Unit and CIBERNED (P.M.-M.), Alzheimer Center Reina Sofia Foundation, Carlos III Institute of Health, Madrid, Spain; Departments of Neurology and Psychiatry (I.H.R.), University of Rochester School of Medicine and Dentistry, Rochester, NY; and School of Psychiatry (S.E.S.), University of Western Australia and Fremantle Hospital, Fremantle, Australia.

Objective: To construct a model for depression in Parkinson disease (PD) and to study the relative contribution of PD-specific and nonspecific risk factors to this model.

Methods: Structural equation modeling of direct and indirect associations of risk factors with the latent depression outcome using a cross-sectional dataset of 342 patients with PD.

Results: A model with acceptable fit was generated that explained 41% of the variance in depression. In the final model, 3 PD-specific variables (increased disease duration, more severe motor symptoms, the use of levodopa) and 6 nonspecific variables (female sex, history of anxiety and/or depression, family history of depression, worse functioning on activities of daily living, and worse cognitive status) were maintained and significantly associated with depression. Nonspecific risk factors had a 3-times-higher influence in the model than PD-specific risk factors.

Conclusion: In this cross-sectional study, we showed that nonspecific factors may be more prominent markers of depression than PD-specific factors. Accordingly, research on depression in PD should focus not only on factors associated with or specific for PD, but should also examine a wider scope of factors including general risk factors for depression, not specific for PD.
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http://dx.doi.org/10.1212/WNL.0b013e3182a4a503DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3795592PMC
September 2013

Rasch analysis of anxiety scales in Parkinson's disease.

J Psychosom Res 2013 May 19;74(5):414-9. Epub 2013 Mar 19.

National School of Public Health, Carlos III Institute of Health, Madrid, Spain.

Objective: Anxiety is a common non-motor symptom in Parkinson's disease (PD). This study analyzed the measurement properties of three frequently used anxiety scales in PD: the Beck Anxiety Inventory (BAI), the Hamilton Anxiety Rating Scale (HARS), and the Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A).

Method: The Rasch model was applied to a multicenter international cohort of 342 patients and assessed the following aspects: fit to the Rasch model, unidimensionality, reliability, response category ordering, item local independence, differential item functioning, and scale targeting.

Results: In their original form, the BAI, HARS, and HADS-A, did not fit the Rasch model. A good fit to the Rasch model was only found after significant modifications, including rescoring some items and deleting those failing to fit the model. For the BAI and HADS-A, these adjustments resulted in unidimensionality. The HARS was not unidimensional and separate analyses were performed for its psychic and somatic subscales. Whereas the somatic anxiety subscale fit the Rasch model, this was achieved for the psychic anxiety subscale after modifications.

Conclusion: None of the currently used anxiety scales display satisfactory measurement properties for assessing anxiety in PD. The results suggest the need to develop a new disease-specific scale for measuring anxiety in PD.
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http://dx.doi.org/10.1016/j.jpsychores.2013.02.009DOI Listing
May 2013

AAV2-GAD gene therapy for advanced Parkinson's disease: a double-blind, sham-surgery controlled, randomised trial.

Lancet Neurol 2011 Apr;10(4):309-19

Wayne State University School of Medicine, Parkinson's Disease and Movement Disorders Program, Henry Ford West Bloomfield Hospital, MI, USA.

Background: Gene transfer of glutamic acid decarboxylase (GAD) and other methods that modulate production of GABA in the subthalamic nucleus improve basal ganglia function in parkinsonism in animal models. We aimed to assess the effect of bilateral delivery of AAV2-GAD in the subthalamic nucleus compared with sham surgery in patients with advanced Parkinson's disease.

Methods: Patients aged 30-75 years who had progressive levodopa-responsive Parkinson's disease and an overnight off-medication unified Parkinson's disease rating scale (UPDRS) motor score of 25 or more were enrolled into this double-blind, phase 2, randomised controlled trial, which took place at seven centres in the USA between Nov 17, 2008, and May 11, 2010. Infusion failure or catheter tip location beyond a predefined target zone led to exclusion of patients before unmasking for the efficacy analysis. The primary outcome measure was the 6-month change from baseline in double-blind assessment of off-medication UPDRS motor scores. This trial is registered with ClinicalTrials.gov, NCT00643890.

Findings: Of 66 patients assessed for eligibility, 23 were randomly assigned to sham surgery and 22 to AAV2-GAD infusions; of those, 21 and 16, respectively, were analysed. At the 6-month endpoint, UPDRS score for the AAV2-GAD group decreased by 8·1 points (SD 1·7, 23·1%; p<0·0001) and by 4·7 points in the sham group (1·5, 12·7%; p=0·003). The AAV2-GAD group showed a significantly greater improvement from baseline in UPDRS scores compared with the sham group over the 6-month course of the study (RMANOVA, p=0·04). One serious adverse event occurred within 6 months of surgery; this case of bowel obstruction occurred in the AAV2-GAD group, was not attributed to treatment or the surgical procedure, and fully resolved. Other adverse events were mild or moderate, likely related to surgery and resolved; the most common were headache (seven patients in the AAV2-GAD group vs two in the sham group) and nausea (six vs two).

Interpretation: The efficacy and safety of bilateral infusion of AAV2-GAD in the subthalamic nucleus supports its further development for Parkinson's disease and shows the promise for gene therapy for neurological disorders.

Funding: Neurologix.
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http://dx.doi.org/10.1016/S1474-4422(11)70039-4DOI Listing
April 2011

Anxiety rating scales in Parkinson's disease: a validation study of the Hamilton anxiety rating scale, the Beck anxiety inventory, and the hospital anxiety and depression scale.

Mov Disord 2011 Feb 7;26(3):407-15. Epub 2011 Mar 7.

Department of Psychiatry, Maastricht University Medical Center, Maastricht, The Netherlands.

Background: Anxiety is a prevalent and disabling condition in Parkinson's disease (PD). The lack of anxiety rating scales validated for this population hampers research into anxiety in PD. The aim of this study is to assess the clinimetric properties of the Hamilton anxiety rating scale (HARS), the Beck anxiety inventory (BAI), and the hospital anxiety and depression scale (HADS) in PD patients.

Design: Three hundred forty-two PD patients underwent a standardized assessment including a structured interview for diagnostic and statistical manual diagnoses of anxiety disorders and completion of the HARS, BAI, and HADS. Inter-rater reliability of the HARS was assessed in 60 patients; test-retest reliability of the BAI and HADS in 213 and 217 patients, respectively.

Results: Thirty-four percent of patients suffered from an anxiety disorder, whereas an additional 11.4% had clinically significant anxiety symptoms in the absence of a diagnosis of anxiety disorder. Acceptability, score distribution, and known groups validity over different levels of anxiety were adequate. Inter-rater reliability for the HARS and test-retest reliability for the BAI and HADS were good. The HARS, but not the BAI and HADS, had a satisfactory inter-item correlation, convergent validity and factorial structure. For all scales, the positive predictive value was poor, and the negative predictive value was moderate.

Conclusions: Given the adequate known groups validity of all three rating scales, each of these scales is likely to be useful in clinical practice or research for evaluation of symptom severity. Limitations in the construct validity of the anxiety scales in this study raise questions regarding suitability for their use in PD.
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http://dx.doi.org/10.1002/mds.23184DOI Listing
February 2011

Symptomatology and markers of anxiety disorders in Parkinson's disease: a cross-sectional study.

Mov Disord 2011 Feb 10;26(3):484-92. Epub 2011 Feb 10.

Department of Psychiatry, Maastricht University Medical Center, Maastricht, The Netherlands.

Anxiety is understudied in Parkinson's disease (PD), which is not justified by the prevalence and impact of anxiety disorders on quality of life in PD patients. In this cross-sectional study, 342 patients suffering from idiopathic PD underwent a research-based assessment including DSM IV criteria for anxiety disorders, the Hamilton anxiety rating scale (HARS) and the beck anxiety inventory (BAI). Thirty-four percent (34%) of subjects met the DSM IV criteria for at least one anxiety disorder; 11.8% met criteria for multiple anxiety disorders; and 11.4% had clinically relevant anxiety symptoms without meeting the criteria for any specific anxiety disorder. Score profiles on the HARS and BAI differed significantly between the disorders, but these differences were associated with different scores on a limited number of items, and the respective symptom profiles were not readily interpretable. Female sex, the presence of motor fluctuations, as well as a previous history of an anxiety disorder were markers for anxiety disorders. The use of a mono-amino oxidase (MAO)-B inhibitor was associated with a reduced prevalence of anxiety disorders. Research into anxiety in PD is hampered by the questionable validity of DSM IV defined anxiety disorders in this population. A first focus for research should therefore be the identification of clinically useful anxiety presentations and their validation in PD.
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http://dx.doi.org/10.1002/mds.23528DOI Listing
February 2011

Anxiety rating scales in Parkinson's disease: critique and recommendations.

Mov Disord 2008 Oct;23(14):2015-25

Department of Psychiatry, Maastricht University Hospital, Maastricht, the Netherlands.

Anxiety syndromes are common in patients with Parkinson's disease (PD) with up to 30% suffering from panic disorder, and up to 11% from generalized anxiety disorder (GAD). Anxiety is associated with increased subjective motor symptoms, more severe gait problems, dyskinesias, freezing, and on/off fluctuations. Anxiety has a negative impact on health related quality of life and is strongly associated with depressive syndromes. Since a variety of anxiety scales have been used in PD patients, the Movement Disorder Society commissioned a task force to assess the clinimetric properties of these scales in PD. A systematic review was conducted to identify anxiety scales that have either been validated or used in patients with PD. Six anxiety rating scales were identified. These were the Beck anxiety inventory, the hospital anxiety and depression scale, the Zung self-rating anxiety scale and anxiety status inventory, the Spielberger state trait anxiety inventory, and the Hamilton anxiety rating scale. In addition, Item 5 (anxiety) of the neuropsychiatric inventory was included in the review. No scales met the criteria to be "recommended," and all scales were classified as "suggested." Essential clinimetric information is missing for all scales. Because several scales exist and have been used in PD, the task force recommends further studies of these instruments. If these studies show that the clinimetric properties of existing scales are inadequate, development of a new scale to assess anxiety in PD should be considered.
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http://dx.doi.org/10.1002/mds.22233DOI Listing
October 2008

Apathy and anhedonia rating scales in Parkinson's disease: critique and recommendations.

Mov Disord 2008 Oct;23(14):2004-14

Department of Psychiatry, Maastricht University Hospital, Maastricht, The Netherlands.

Apathy is a common condition in Parkinson's disease (PD) and is generally defined as a lack of motivation. It is associated with more severe cognitive dysfunction and a decrease in activities of daily living (ADL) performance. Anhedonia, the inability to experience pleasure, can be a symptom of both depressive and apathetic syndromes. The Movement Disorder Society (MDS) commissioned a task force to assess the clinimetric properties of apathy and anhedonia scales in PD patients. A systematic literature review was conducted to identify scales that have either been validated or used in PD patients. Apathy scales identified for review include the Apathy Evaluation Scale (AES), the Apathy Scale (AS), the Apathy Inventory (AI), and the Lille Apathy Rating Scale (LARS). In addition, item 4 (motivation/initiative) of the Unified Parkinson's Disease Rating Scale (UPDRS) and item 7 (apathy) of the Neuropsychiatric Inventory (NPI) were included. Anhedonia scales identified for review were the Snaith-Hamilton Pleasure Scale (SHAPS) and the Chapman scales for physical and social anhedonia. Only the AS is classified as "recommended" to assess apathy in PD. Although item 4 of the UPDRS also meets the criteria to be classified as recommended, it should be considered for screening only because of the obvious limitations of a single item construct. For the assessment of anhedonia, only the SHAPS meets the criteria of "Suggested." Information on the validity of apathy and anhedonia scales is limited because of the lack of consensus on diagnostic criteria for these conditions.
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http://dx.doi.org/10.1002/mds.22229DOI Listing
October 2008

Mood fluctuations in Parkinson's disease: a pilot study comparing the effects of intravenous and oral levodopa administration.

Neuropsychiatr Dis Treat 2005 Sep;1(3):261-8

Departments of Neurology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.

Objectives: Parkinson's disease (PD) is associated with motor fluctuations that have been shown to improve when stable plasma levodopa levels are achieved with continuous levodopa infusions. Many patients also develop mood fluctuations. In this pilot study, we gathered preliminary information about the relationship between changing mood states and plasma levodopa levels.

Methods: Six patients with idiopathic PD and histories of motor and mood fluctuations participated in a double-blind levodopa infusion study. Subjects received active oral carbidopa/levodopa and a placebo levodopa infusion on one day and placebo oral carbidopa/levodopa and an active levodopa infusion on the other day, in a randomly determined order. Evaluations included serial plasma levodopa levels and assessments of mood and motor states.

Results: Only 4 of the 6 subjects demonstrated mood fluctuations on at least one of the treatment days. All subjects achieved more stable plasma levodopa levels on the active infusion day. Two subjects experienced fewer mood fluctuations on the active infusion day and two experienced fewer on the oral day. Conclusions The results of this pilot study suggest that the relationship between mood state and plasma levodopa level may vary among PD patients.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2416757PMC
September 2005

The patients' perspective: Results of a survey assessing knowledge about and attitudes toward depression in PD.

Neuropsychiatr Dis Treat 2007 Dec;3(6):903-6

University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.

We report results of a survey assessing patients' knowledge about and attitudes towards depression in Parkinson's disease (PD). 345 patients from 8 tertiary care centers responded (43% response rate). Overall, patients were relatively knowledgeable about depression and its occurrence in PD. However, many patients believed that depression is a normal reaction to the illness. While many respondents would be reluctant to initiate a discussion of depression during a clinical evaluation, most would feel comfortable talking about depression with their physician if he or she asked them questions about their mood. Based on the results of this survey, we recommend the following approach for physicians: (1) inform PD patients that, although a frequent occurrence, depression need not be accepted as a "normal reaction" to PD; and (2) routinely inquire about depressive symptoms rather than waiting for the patient to spontaneously report them.
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http://dx.doi.org/10.2147/ndt.s1214DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2656333PMC
December 2007

Risk factors for somnolence, edema, and hallucinations in early Parkinson disease.

Neurology 2007 Jul;69(2):187-95

University of Rochester, Department of Neurology, Rochester, NY 14620, USA.

Background: The CALM-PD trial evaluated the development of motor complications in subjects with early Parkinson disease (PD) randomized to initial treatment with either pramipexole or levodopa. A secondary finding of the trial was a higher than anticipated development or worsening of somnolence and edema and development of hallucinations.

Objectives: To investigate risk factors for somnolence, edema, and hallucinations in patients with early PD initiating dopaminergic therapy.

Methods: This was a secondary analysis of data from the CALM-PD trial. Baseline patient characteristics were evaluated for their associations with the development or worsening of somnolence and edema and the development of hallucinations using Cox proportional hazards regression models.

Results: Kaplan-Meier estimates of the 4-year incidence of the development or worsening of somnolence and edema and the development of hallucinations were 35%, 45%, and 17%. Initial pramipexole treatment (hazard ratio [HR] 2.22, 95% CI 1.41, 3.50, p < 0.001), male gender (HR 1.79, 95% CI 1.09, 2.93, p = 0.02), and >5 systems with a comorbid illness (HR 1.62, 95% CI 1.04, 2.51, p = 0.03) were associated with somnolence. Initial pramipexole treatment (HR 3.18, 95% CI 1.95, 5.18, p < 0.0001), female gender (HR 1.46, 95% CI 0.94, 2.27, p = 0.09), and comorbid cardiac disease (HR 1.59, 95% CI 1.02, 2.47, p = 0.04) were associated with edema. Age > or =65 (HR 2.06, 95% CI 0.98, 4.32, p = 0.06), Mini-Mental State Examination score >28 (HR 0.42, 95% CI 0.19, 0.91, p = 0.03), and >5 systems with a comorbid illness (HR 3.42, 95% CI 1.59, 7.38, p = 0.002) were associated with hallucinations.

Conclusions: Comorbid illnesses are important and overlooked risk factors for the development of somnolence, edema, and hallucinations. When initiating therapy with pramipexole, patients should be counseled about and monitored for somnolence and edema. Slight decrements in cognitive function and older age are associated with an increased risk of hallucinations.
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http://dx.doi.org/10.1212/01.wnl.0000265593.34438.00DOI Listing
July 2007
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