scholarly journals The Effect of Rotigotine on Cognitive Function and Sleep Problems in Parkinson's Disease: an Open-Label Pilot Study

2021 ◽  
Author(s):  
Keisuke Suzuki ◽  
Kei Funakoshi ◽  
Hiroaki Fujita ◽  
Koichi Hirata
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Cognitive Function ◽  
Daytime Sleepiness ◽  
Sleep Disturbances ◽  
Rating Scale ◽  
Sleep Problems ◽  
Motor Symptoms ◽  
Open Label ◽  
Updrs Part

Abstract Background: We hypothesized that rotigotine may have a positive effect on cognitive function in patients with Parkinson’s disease (PD) by improving daytime motor function and nighttime sleep status due to its 24-hour sustained properties.Methods: We evaluated the effect of rotigotine on motor symptoms, cognitive function, daytime sleepiness, sleep disturbances, and motor symptoms in 10 PD patients with sleep disturbances, defined as a PD Sleep Scale (PDSS)-2 score of ≥ 15, in a single-center, 3-month open-label study. Participants received 24 mg/24 h (patch content: 4.5-9 mg) rotigotine for a 3-month period. At baseline and 3 months, patients were evaluated on the Movement Disorder Society Revision of the Unified PD Rating Scale (MDS-UPDRS) parts III and IV and cognitive assessments, such as the Mini-Mental State Examination (MMSE), frontal assessment battery (FAB) and Montreal Cognitive Assessment (MoCA). The Epworth Sleepiness Scale (ESS) and PDSS-2 were administered at baseline and at 1 month, 2 months and 3 months.Results: At 3 months, MDS-UPDRS part III (-10.7, p<0.001) and MDS-UPDRS part IV (-1.0, p=0.023) scores significantly decreased, MoCA scores (1.7, p=0.0095) significantly increased, and off time significantly decreased (-43.0 min; p=0.029) from baseline. PDSS-2 scores significantly decreased from baseline at 2 months (-14.5, p<0.05) and 3 months (-20.0, p<0.001). ESS, MMSE or FAB scores did not significantly change after rotigotine treatment.Conclusion: Our preliminary findings suggest that low-dose rotigotine could improve motor symptoms, sleep disturbance, and cognitive function without worsening daytime sleepiness in patients with PD.

scholarly journals Baseline prevalence and longitudinal evolution of non-motor symptoms in early Parkinson’s disease: the PPMI cohort

2017 ◽  
Vol 89 (1) ◽  
pp. 78-88 ◽  
Author(s):  
Tanya Simuni ◽  
Chelsea Caspell-Garcia ◽  
Christopher S Coffey ◽  
Daniel Weintraub ◽  
Brit Mollenhauer ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Rating Scale ◽  
De Novo ◽  
Controlled Study ◽  
Motor Symptoms ◽  
Biological Variables ◽  
Significant Difference ◽  
Non Motor Symptoms ◽  
Updrs Part

ObjectiveTo examine the baseline prevalence and longitudinal evolution in non-motor symptoms (NMS) in a prospective cohort of, at baseline, patients with de novo Parkinson’s disease (PD) compared with healthy controls (HC).MethodsParkinson’s Progression Markers Initiative (PPMI) is a longitudinal, ongoing, controlled study of de novo PD participants and HC. NMS were rated using the Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part I score and other validated NMS scales at baseline and after 2 years. Biological variables included cerebrospinal fluid (CSF) markers and dopamine transporter imaging.Results423 PD subjects and 196 HC were enrolled and followed for 2 years. MDS-UPDRS Part I total mean (SD) scores increased from baseline 5.6 (4.1) to 7.7 (5.0) at year 2 in PD subjects (p<0.001) versus from 2.9 (3.0) to 3.2 (3.0) in HC (p=0.38), with a significant difference between the groups (p<0.001). In the multivariate analysis, higher baseline NMS score was associated with female sex (p=0.008), higher baseline MDS-UPDRS Part II scores (p<0.001) and more severe motor phenotype (p=0.007). Longitudinal increase in NMS severity was associated with the older age (0.008) and lower CSF Aβ1–42 (0.005) at baseline. There was no association with the dose or class of dopaminergic therapy.ConclusionsThis study of NMS in early PD identified clinical and biological variables associated with both baseline burden and predictors of progression. The association of a greater longitudinal increase in NMS with lower baseline Aβ1–42 level is an important finding that will have to be replicated in other cohorts.Trial registrationClinicalTrials.gov identifier: NCT01141023.

scholarly journals Is the MDS-UPDRS a Good Screening Tool for Detecting Sleep Problems and Daytime Sleepiness in Parkinson’s Disease?

2014 ◽  
Vol 2014 ◽  
pp. 1-8 ◽  
Author(s):  
Krisztina Horváth ◽  
Zsuzsanna Aschermann ◽  
Péter Ács ◽  
Edit Bosnyák ◽  
Gabriella Deli ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Daytime Sleepiness ◽  
Screening Tool ◽  
Rating Scale ◽  
Sleep Problems ◽  
Rank Correlation ◽  
Correlation Coefficients ◽  
Moderate Correlation ◽  
Cross Sectional

Movement Disorder Society-sponsored Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) has separate items for measuring sleep problems (item 1.7) and daytime sleepiness (1.8). The aim of our study was to evaluate the screening sensitivity and specificity of these items to the PD Sleep Scale 2nd version (PDSS-2) and Epworth Sleepiness Scale (ESS). In this nationwide, cross-sectional study 460 PD patients were enrolled. Spearman’s rank correlation coefficients were calculated between the individual items, domains, and the total score of PDSS-2 and item 1.7 of MDS-UPDRS. Similarly, the items and the total score of ESS were contrasted to item 1.8 of MDS-UPDRS. After developing generalized ordinal logistic regression models, the transformed and observed scores were compared by Lin’s Concordance Correlation Coefficient. Only item 3 difficulties staying asleep and the “disturbed sleep” domain of PDSS-2 showed high correlation with “sleep problems” item 1.7 of the MDS-UPDRS. Total score of PDSS-2 had moderate correlation with this MDS-UPRDS item. The total score of ESS showed the strongest, but still moderate, correlation with “daytime sleepiness” item 1.8 of MDS-UPDRS. As intended, the MDS-UPDRS serves as an effective screening tool for both sleep problems and daytime sleepiness and identifies subjects whose disabilities need further investigation.

scholarly journals Open-Label Study of Sleep Disturbances in Patients with Parkinson’s Disease Treated with Rasagiline

2016 ◽  
Vol 43 (6) ◽  
pp. 809-814 ◽  
Author(s):  
Michel Panisset ◽  
Jean-Louis Stril ◽  
Manon Bélanger ◽  
Geneviève Lehoux ◽  
Donna Coffin ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Clinical Global Impression ◽  
Daytime Sleepiness ◽  
Treatment Satisfaction ◽  
Sleep Disturbances ◽  
Open Label ◽  
Adjunct Therapy ◽  
Satisfaction Questionnaire ◽  
The Impact

AbstractBackground: The prevalence of sleep disturbances among patients with Parkinson’s disease (PD) is estimated to occur in 37% to 98% of patients. Sleep disturbances have been associated with a reduced quality of life for patients with PD. The objective of this study was to assess the impact of rasagiline treatment on the severity of sleep disturbances among patients with idiopathic PD. Methods: In this open-label, multicentre study, 110 adult patients with idiopathic PD were treated with rasagiline either as monotherapy or as adjunct therapy. The primary endpoint was the change in severity of sleep disturbances, assessed with the PD Sleep Scale from baseline to month 2. Exploratory endpoints included change in daytime sleepiness, assessed with the Epworth Sleep Scale, treatment satisfaction measured with the Treatment Satisfaction Questionnaire for Medication, patient’s overall improvement or deterioration over time measured with the Clinical Global Impression of Improvement, tolerability, and safety. Findings: Patients treated with rasagiline as mono- or adjunct therapy showed a statistically significant improvement in sleep quality after 2 months. There was no change in daytime sleepiness. Overall, patients were satisfied with rasagiline treatment with a mean Treatment Satisfaction Questionnaire for Medication [standard deviation] total score at month 2 of 68% [16.1]. At the end of study, 64 patients (65.9%) were judged, by the investigator, as being at least minimally improved from baseline on the Clinical Global Impression of Improvement. Rasagiline was safe and well-tolerated. Interpretation: Rasagiline as mono- or adjunct-therapy may improve sleep experience in patients with PD in the short term.

scholarly journals Dopamine-Induced Nonmotor Symptoms of Parkinson's Disease

2011 ◽  
Vol 2011 ◽  
pp. 1-6 ◽  
Author(s):  
Ariane Park ◽  
Mark Stacy
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Side Effects ◽  
Sleep Disturbances ◽  
Complex Disease ◽  
Sleep Problems ◽  
Motor Symptoms ◽  
Nonmotor Symptoms ◽  
Neuropsychiatric Complications ◽  
Non Motor Symptoms

Nonmotor symptoms of Parkinson's disease (PD) may emerge secondary to the underlying pathogenesis of the disease, while others are recognized side effects of treatment. Inevitably, there is an overlap as the disease advances and patients require higher dosages and more complex medical regimens. The non-motor symptoms that emerge secondary to dopaminergic therapy encompass several domains, including neuropsychiatric, autonomic, and sleep. These are detailed in the paper. Neuropsychiatric complications include hallucinations and psychosis. In addition, compulsive behaviors, such as pathological gambling, hypersexuality, shopping, binge eating, and punding, have been shown to have a clear association with dopaminergic medications. Dopamine dysregulation syndrome (DDS) is a compulsive behavior that is typically viewed through the lens of addiction, with patients needing escalating dosages of dopamine replacement therapy. Treatment side effects on the autonomic system include nausea, orthostatic hypotension, and constipation. Sleep disturbances include fragmented sleep, nighttime sleep problems, daytime sleepiness, and sleep attacks. Recognizing the non-motor symptoms that can arise specifically from dopamine therapy is useful to help optimize treatment regimens for this complex disease.

scholarly journals Clinical long-term nocturnal sleeping disturbances and excessive daytime sleepiness in Parkinson’s disease

PLoS ONE ◽  
2021 ◽  
Vol 16 (12) ◽  
pp. e0259935
Author(s):  
Rocio Del Pino ◽  
Ane Murueta-Goyena ◽  
Unai Ayala ◽  
Marian Acera ◽  
Mónica Fernández ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Excessive Daytime Sleepiness ◽  
Daytime Sleepiness ◽  
Sleep Disturbances ◽  
Sleep Problems ◽  
Motor Impairment ◽  
Nocturnal Sleep ◽  
Nocturnal Problems ◽  
Over Time

Objective To prospectively evaluate nocturnal sleep problems and excessive daytime sleepiness (EDS) in Parkinson’s disease (PD) patients, and analyze the influence of motor symptoms, treatment, and sex differences on sleep problems in PD. Methods Sleep disturbances of 103 PD patients were assessed with Parkinson’s Disease Sleep Scale (PDSS) and the Epworth Sleepiness Scale (ESS). Student’s t-test for related samples, one-way ANOVA with Tukey’s HSD post hoc test were used to assess group differences. Bivariate correlations and mixed-effects linear regression models were used to analyze the association between clinical aspects and sleep disturbances over time. Results At baseline, 48.5% of PD patients presented nocturnal problems and 40% of patients presented EDS. The PDSS and ESS total score slightly improve over time. Nocturnal problems were associated with age and motor impartment, explaining the 51% of the variance of the PDSS model. Males presented less nocturnal disturbances and more EDS than females. Higher motor impairment and combined treatment (L-dopa and agonist) were related to more EDS, while disease duration and L-dopa in monotherapy were related to lower scores, explaining the 59% of the model. Conclusions Sleep disturbances changed over time and age, diseases duration, motor impairment, treatment and sex were associated with nocturnal sleep problems and EDS. Agonist treatment alone or in combination with L-dopa might predict worse daytime sleepiness, while L-dopa in monotherapy is related to lower EDS, which significantly affects the quality of life of PD patients.

scholarly journals Sleep disturbances in patients with Parkinson's disease

2010 ◽  
Vol 138 (5-6) ◽  
pp. 274-278 ◽  
Author(s):  
Tatjana Smiljkovic
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Sleep Disturbances ◽  
Rating Scale ◽  
Sleep Problems ◽  
Cognitive Status ◽  
Neurodegenerative Process ◽  
Treatment Data ◽  
Advanced Stages ◽  
Neurochemical Changes

Introduction Sleep problems, common in Parkinson's disease (PD), are the consequence of the neurodegenerative process, as well as of neurochemical changes on one side, and of drug intake on the other side. Objective To estimate the frequency of sleep problems and its correlation with the disease, therapy and demographic factors in patients with idiopathic Parkinson's disease. Methods The study enrolled 65 consecutive patients who fulfilled criteria for idiopathic PD. The original questionnaire was performed to obtain demographic, disease and treatment data. The patients were tested with standardized scales: unified PD rating scale (UPDRS) and Hoehn and Yahr staging scale (HY scale). Mini mental stage examination (MMSE) was performed for the evaluation of cognitive status. Parkinson's disease sleep scale (PDSS) was applied for the assessment of sleep problems. Results There were 37 male and 28 female patients. Negative correlations (p<0.01) were found between mean total PDSS and mean total UPDRS, as well as the mean scores of each part of UPDRS and HY stage. There was no difference in PDSS scores regarding gender. Analyzing each item in the PDSS scale, the lowest score was obtained for item 8 (nocturia). We did not find any difference in total PDSS scores between the patients on d-agonist and those who did not take d-agonist. Regarding amantadin, intake there were differences between groups for items concerning nocturnal motor symptoms. Conclusion Patients in advanced stages of the disease and worse motility have more prominent sleep problems. Drug therapy has important impact on sleep quality in patients with PD. .

scholarly journals Transdermal Rotigotine Improves Sleep Fragmentation in Parkinson’s Disease: Results of the Multicenter, Prospective SLEEP-FRAM Study

2015 ◽  
Vol 2015 ◽  
pp. 1-7 ◽  
Author(s):  
Javier Pagonabarraga ◽  
Gerard Piñol ◽  
Adriana Cardozo ◽  
Pilar Sanz ◽  
Víctor Puente ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Sleep Disturbances ◽  
Sleep Problem ◽  
Subscale Score ◽  
Sleep Fragmentation ◽  
Motor Symptoms ◽  
Open Label ◽  
Sleep Maintenance ◽  
Sleep Parameters

Sleep disturbances occur frequently in patients with Parkinson’s disease (PD). The aim of this study was to investigate the effects of rotigotine on sleep fluctuations in a sample of PD patients with self-reported complaints of nocturnal awakenings. This prospective, open-label, observational, and multicenter study enrolled consecutive outpatients with PD and administered rotigotine (mean dose 8.9 mg/day) for 3 months. The primary endpoint was the change from baseline in sleep fragmentation, assessed using the sleep maintenance subscale score of the Parkinson’s Disease Sleep Scale (PDSS). The newly designed Parkinson’s Disease Sleep Fragmentation Questionnaire (PD-SFQ) was used to measure other sleep parameters. A total of 62 patients were enrolled (mean age 70.2 years; 66% male). At 3 months, rotigotine significantly improved sleep fragmentation from baseline on the PDSS-2 sleep maintenance subscale (from3.4±0.9to1.9±1.4;P<0.0001). Rotigotine also significantly improved nocturnal motor symptomsP<0.0001, restless legs-like symptomsP<0.005, and nocturiaP=0.004. Rotigotine significantly improved self-reported complaints of sleep fragmentation in PD patients and could be a useful treatment to improve this specific sleep problem in PD. However, these results are based on a small and clinically heterogeneous sample so they must be taken cautiously.

A Dual Centre Study of Pain in Parkinson’s Disease and Its Relationship with Other Non-Motor Symptoms

2020 ◽  
Vol 10 (4) ◽  
pp. 1817-1825
Author(s):  
Pritha Ghosh ◽  
Paola Imbriani ◽  
Nicoletta Caputi ◽  
Silvia Natoli ◽  
Tommaso Schirinzi ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Rating Scale ◽  
Clustering Algorithms ◽  
Motor Symptom ◽  
Sleep Disruption ◽  
Motor Symptoms ◽  
Cross Sectional ◽  
Non Motor Symptoms ◽  
Updrs Part

Background: Pain is a disabling and often underestimated non-motor symptom (NMS) detrimentally affecting the quality of life of patients with Parkinson’s disease (PD). Objective: Here, we conducted a cross-sectional, observational international study on 167 patients with idiopathic PD in order to analyze the potential relationship between pain and other NMS. Methods: Subjects were assessed with the Unified Parkinson’s Disease Rating Scale (UPDRS) part III, Hoehn and Yahr (H&Y) stage, King’s Parkinson’s Disease Pain Scale (KPPS), Brief Pain Inventory (BPI), Non-Motor Symptoms Scale (NMSS), and Beck Depression Inventory (BDI). Spearman’s rank correlation coefficient, multiple regression and multiple index-based clustering algorithms were used for data analysis. Results: The prevalence of pain was 88.6%, was not correlated with age, motor severity (UPDRS part III) or disease duration, whereas a weak correlation with female gender and H&Y stage >2.5 was found. Multiple NMS correlated significantly with pain. Specifically, sleep disturbance had the strongest correlation with pain, followed by depression, gastrointestinal and cardiovascular disturbances. Further analyses showed that sleep and cardiovascular disturbance were independently associated with pain, and that these symptoms clustered together in a subset of PD patients. The relationship between pain, sleep and dysautonomia persisted independently from dopamine replacement therapy. Conclusion: Our study suggests that sleep disruption and cardiovascular disturbance are associated with pain in PD, and possibly identifies a specific subtype within PD patients with pain. Our data also indicate that sleep disruption, pain and dysautonomia may have a common pathophysiology, possibly involving non-dopaminergic pathways.

scholarly journals Unilateral pallidothalamic tractotomy for akinetic-rigid Parkinson’s disease: a prospective open-label study

2021 ◽  
pp. 1-7
Author(s):  
Shiro Horisawa ◽  
Atsushi Fukui ◽  
Hayato Yamahata ◽  
Yukiko Tanaka ◽  
Atsushi Kuwano ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Rating Scale ◽  
Contralateral Side ◽  
Neurological Deficits ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Daily Dose ◽  
Updrs Part

OBJECTIVENeurosurgical ablation is an effective treatment for medically refractory motor symptoms of Parkinson’s disease (PD). A limited number of studies have reported the effect of ablation of the pallidothalamic tract for PD. In this study, the authors evaluated the safety and efficacy of unilateral pallidothalamic tractotomy for akinetic-rigid (AR)–PD.METHODSFourteen AR-PD patients, who were enrolled in this prospective open-label study, underwent unilateral pallidothalamic tractotomy. The Movement Disorder Society–Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III and Part IV (dyskinesia and dystonia) scores and levodopa equivalent daily dose (LEDD) were evaluated at baseline and at 3 and 12 months postoperatively.RESULTSOf the 14 patients enrolled in the study, 4 were lost to follow-up and 10 were analyzed. The total MDS-UPDRS Part III score significantly improved from 45 ± 4.6 at baseline to 32.9 ± 4.8 at 12 months postoperatively (p = 0.005). Contralateral side rigidity and bradykinesia significantly improved from 4.4 ± 0.5 and 10.4 ± 1.5 at baseline to 1.7 ± 0.4 (p = 0.005) and 5.2 ± 1.4 (p = 0.011) at 12 months, respectively. While posture significantly improved with a 20% reduction in scores (p = 0.038), no significant improvement was found in gait (p = 0.066). Dyskinesia and dystonia were improved with a 79.2% (p = 0.0012) and 91.7% (p = 0.041) reduction in scores, respectively. No significant change was found in the LEDD. Hypophonia was noted in 2 patients, eyelid apraxia was noted in 1 patient, and a reduced response to levodopa, which resulted in an increase in the daily dose of levodopa, was noted in 3 patients. No serious permanent neurological deficits were observed.CONCLUSIONSUnilateral pallidothalamic tractotomy improved contralateral side rigidity and bradykinesia, dyskinesia, and dystonia in patients with AR-PD.Clinical trial registration no.: UMIN000031138 (umin.ac.jp)

scholarly journals PF-06649751 efficacy and safety in early Parkinson’s disease: a randomized, placebo-controlled trial

2020 ◽  
Vol 13 ◽  
pp. 175628642091129 ◽  
Author(s):  
Robert Riesenberg ◽  
John Werth ◽  
Yao Zhang ◽  
Sridhar Duvvuri ◽  
David Gray
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Rating Scale ◽  
Early Stage ◽  
Partial Agonist ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Motor Symptoms ◽  
Efficacy And Safety ◽  
Updrs Part

Background: PF-06649751 is a novel, oral, non-catechol-based, D1/D5 dopamine receptor partial agonist under investigation for the treatment of motor symptoms associated with Parkinson’s disease. Methods: A 15-week, phase II, double-blind, placebo-controlled clinical trial was conducted to assess the efficacy and safety of flexible-dose PF-06649751 in subjects with early stage Parkinson’s disease (ClinicalTrials.gov identifier: NCT02847650). Results: Enrollment was terminated early for reasons unrelated to the trial. Overall, 57 subjects received study medication (PF-06649751 = 29; placebo = 28) and 47 completed the study (PF-06649751 = 25; placebo = 22). Despite early termination, the study met its primary endpoint with the PF-06649751 group showing statistically significant improvement from baseline in the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III score at week 15 compared with placebo. Mean (SE) change in MDS-UPDRS Part III score was −9.0 (1.54) for PF-06649751 and −4.3 (1.65) for placebo. This corresponds to an improvement versus placebo of 4.8 for the PF-06649751 group (two-sided p = 0.0407; 90% CI = 1.0, 8.6). Statistically significant improvement in MDS-UPDRS-III score was also observed at all assessment time points prior to week 15. The safety profile of PF-06649751 was similar to that observed in prior studies, with the majority of adverse events (AEs) reported as mild or moderate. The most common AEs in the PF-06649751 group were nausea, headache, dry mouth, somnolence, and tremor. Conclusions: Once-daily dosing of oral PF-06649751 resulted in significant improvement of motor symptoms and was generally well tolerated in subjects with early stage Parkinson’s disease.

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