Journal of Parkinson's Disease - Volume 7, issue 3

Authors: Gibbons, Christopher H. | Wang, Ningshan | Freeman, Roy

Article Type: Research Article

Abstract: Background: Parkinson disease (PD) is neurodegenerative disorder characterized by tremor, rigidity and bradykinesia and pathologically by the deposition of alpha-synuclein within different tissues. We, and others, have reported the detection of cutaneous alpha-synuclein in individuals with PD. Objective: The goal of the present study was to detect alpha-synuclein deposition by immunohistochemical staining of skin samples in pathologically confirmed cases of PD. Methods: Post-mortem skin biopsy samples from 11 individuals with PD, and 5 non-synucleinopathy control subjects were paraffin embedded and stained for total alpha-synuclein and protein gene product 9.5. Results: Alpha-synuclein deposition was greater …in both scalp and abdominal skin biopsy PD samples compared to control samples in pilomotor nerves (P  < 0.05), sudomotor nerves (P  < 0.05) and vasomotor nerves (P  < 0.05). Deposition of alpha-synuclein in scalp and abdominal tissue did not correlate with age, duration of PD, or severity of PD. Conclusions: There is greater deposition of alpha-synuclein within pilomotor, sudomotor and vasomotor nerve fibers of paraffin embedded samples from autopsy confirmed cases of PD compared to control samples. However, assessment of alpha-synuclein deposition in post-mortem paraffin embedded tissue has many limitations and the utility of this technique in clinical and research studies is uncertain. Show more

Keywords: Parkinson’s disease, alpha-synuclein, skin biopsy, autonomic

DOI: 10.3233/JPD-171088

Citation: Journal of Parkinson's Disease, vol. 7, no. 3, pp. 503-509, 2017

Authors: Hauser, Robert A. | Pahwa, Rajesh | Tanner, Caroline M. | Oertel, Wolfgang | Isaacson, Stuart H. | Johnson, Reed | Felt, Larissa | Stempien, Mary Jean

Article Type: Research Article

Abstract: Background: Medical treatment of levodopa-induced dyskinesia (LID) in Parkinson’s disease (PD) is an unmet need. ADS-5102 (amantadine) extended-release capsules is being developed for the treatment of LID in patients with PD. Objective: Evaluate the long-term safety and tolerability of 274 mg ADS-5102 for LID in PD. Methods: In an ongoing, open-label safety study (NCT02202551), PD patients with LID received 274 mg of ADS-5102 once daily at bedtime. Patients were recruited from previous ADS-5102 trials. In addition, patients were enrolled who were ineligible for previous ADS-5102 trials due to previous implantation of deep-brain stimulation (DBS) devices. The primary outcome …measure was safety assessed through adverse events (AEs). Efficacy was assessed using the Movement Disorder Society–Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), Part IV and its subparts. Results: For this interim analysis, 223 patients received ADS-5102 for a mean duration of 348 (SD 182) days. The most common AEs included falls (25.1%), visual hallucinations (19.3%), peripheral edema (13.0%), and constipation (12.6%). Overall, 32 patients (14.3%) discontinued due to an AE. In patients receiving placebo in previous studies, the mean MDS-UPDRS, Part IV scores decreased by 3.4 points from baseline (n  = 78) to week 8 and remained stable through week 64 (n  = 21). In patients receiving ADS-5102 in previous studies, the mean baseline (n  = 61) MDS-UPDRS, Part IV score was low due to the response to ADS-5102 in previous studies and remained stable through week 64 (total of 88 weeks; n  = 21). The effect was primarily due to reduction in item 4.2 (functional impact of dyskinesia) and item 4.4 (functional impact of motor fluctuations). Conclusions: ADS-5102 was generally well tolerated in all groups, including DBS patients, and the safety profile was consistent with previous controlled studies. Long-term durability and tolerability were shown from the double-blind studies through participation in the open-label study up to 88 weeks. Show more

Keywords: Parkinson’s disease, levodopa-induced dyskinesia, dyskinesia, amantadine

DOI: 10.3233/JPD-171134

Citation: Journal of Parkinson's Disease, vol. 7, no. 3, pp. 511-522, 2017

Authors: Mursaleen, Leah Rose | Stamford, Jon Andrew | Jones, David Ashford | Windle, Richard | Isaacs, Tom

Article Type: Research Article

Abstract: Background: The ownership and sharing of patient medical data is an increasingly contentious subject in medicine generally but also within the field of Parkinson’s disease (PD). Despite being the providers of the medical data, patients are rarely consulted as to its usage. Objective: The objective of this paper is to establish patient attitudes to ownership of their own medical data and the sharing thereof. Methods: We report here the results of an online survey of people with Parkinson’s. A total of 310 people took part in the ‘sharing data’ component of the survey, answering some or …all of the questions for which they were eligible. Results: Most respondents (208/306) were aged between 55 and 74 years. 55% of the sample were female and the mean number of years diagnosed was 7.1. Although 93% of respondents were willing to share data, only 41% were currently doing so and a further 8% did not know whether they were sharing any information in this way. There was a significant association between age and data sharing (p  = 0.006). However, no clear relationship was found between data sharing and the number of years diagnosed, sex, medication class or health confidence. There was also no consensus among patients on ownership of, access to and usage of their research data. Conclusion: The lack of consensus on data ownership and general absence of clear demographic predictors of data sharing implies impaired communication pathways. We suggest that strategies directed towards improved communication may help to clarify data ownership and promote data sharing. Show more

Keywords: Parkinson’s disease, data collection, data sharing, data ownership, anonymity, communication

DOI: 10.3233/JPD-161045

Citation: Journal of Parkinson's Disease, vol. 7, no. 3, pp. 523-531, 2017

Authors: de Roos, Paul | Bloem, Bastiaan R. | Kelley, Thomas A. | Antonini, Angelo | Dodel, Richard | Hagell, Peter | Marras, Connie | Martinez-Martin, Pablo | Mehta, Shyamal H. | Odin, Per | Chaudhuri, Kallol Ray | Weintraub, Daniel | Wilson, Bil | Uitti, Ryan J.

Article Type: Research Article

Abstract: Background: Parkinson’s disease (PD) is a progressive neurodegenerative condition that is expected to double in prevalence due to demographic shifts. Value-based healthcare is a proposed strategy to improve outcomes and decrease costs. To move towards an actual value-based health care system, condition-specific outcomes that are meaningful to patients are essential. Objective: Propose a global consensus standard set of outcome measures for PD. Methods: Established methods for outcome measure development were applied, as outlined and used previously by the International Consortium for Health Outcomes Measurement (ICHOM). An international group, representing both patients and experts from the fields …of neurology, psychiatry, nursing, and existing outcome measurement efforts, was convened. The group participated in six teleconferences over a six-month period, reviewed existing data and practices, and ultimately proposed a standard set of measures by which patients should be tracked, and how often data should be collected. Results: The standard set applies to all cases of idiopathic PD, and includes assessments of motor and non-motor symptoms, ability to work, PD-related health status, and hospital admissions. Baseline demographic and clinical variables are included to enable case mix adjustment. Conclusions: The Standard Set is now ready for use and pilot testing in the clinical setting. Ultimately, we believe that using the set of outcomes proposed here will allow clinicians and scientists across the world to document, report, and compare PD-related outcomes in a standardized fashion. Such international benchmarks will improve our understanding of the disease course and allow for identification of ‘best practices’, ultimately leading to better informed treatment decisions. Show more

Keywords: Delivery of Health Care*/economics, Delivery of Health Care*/standards, Efficiency, Organizational, International Cooperation, Health Care Costs Health Status, Health Surveys, Health Surveys/Health Status Indicators, Humans, Outcome Assessment (Health Care), Quality of Health Care, Quality Indicators, Health Care/standards, Quality of Life, Aged, Middle Aged, Disability Evaluation, Disease Progression, Female, Male, Parkinsonian Disorders, Parkinson Disease, Parkinson Disease/epidemiology, Parkinson Disease, Psychometrics, Activities of Daily Living, Outcome and Process Assessment (Health Care)/standards, Parkinson Disease/therapy*

DOI: 10.3233/JPD-161055

Citation: Journal of Parkinson's Disease, vol. 7, no. 3, pp. 533-543, 2017