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This is an open-label study to investigate the effects of the rivastigmine patch on attention and behavior in Parkinson's disease with Dementia (PDD). Rivastigmine is an FDA approved medication used for the treatment of mild to moderate Alzheimer's Disease (AD) and dementia due to Parkinson's disease. Recently a rivastigmine patch was developed, which has shown similar effectiveness with fewer side effects and increased caregiver preference when compared to capsules for the treatment of AD, but has had poor documentation when tested in PDD. This is an open-label 12 week study where 15 subjects diagnosed with PDD (people who have known Parkinson's Disease and have mild to moderate memory and/or thinking complaints) will be treated with the rivastigmine patch at UCSF. This study also analyzes the mechanism by which the rivastigmine patch works in PDD.
Upon referral to this study, subjects will undergo screening to ensure they meet inclusion criteria. At screening, participants will undergo an interview (prior medical & psychiatric history), neuropsychological testing, and physical & neurological exam, including UPDRS to measure parkinsonian symptoms and Hachinski score to measure cerebrovascular disease. At the end of the screening visit, the neurologist will evaluate whether the participant meets PDD research criteria and will also re-review the inclusion/exclusion criteria to ensure that the participants meets criteria for the study. All participants will undergo vital signs and an ECG to ensure minimal cardiovascular risk prior to receiving rivastigmine. Appropriate lab work will also be performed to exclude other potential causes of cognitive impairment.
At baseline visits, participants will undergo a short neurological exam, an MRI scan, attention testing, and a detailed behavioral assessment, after which they will be started on a 5cm2/24hr rivastigmine patch. After 4 weeks, the dose will be increased to a recommended target dose of 9.5cm2/24hr patch. At this visit a short neurological exam will also be conducted. After 12 weeks, participants will again undergo a short neurological exam, an fMRI scan, attention testing and a behavioral assessment. Adverse events and compliance will be assessed every 2 weeks of the study.
Informants will be asked to complete questionnaires regarding the primary participant at the baseline and 12 week visits.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Parkinsons Disease With Dementia
Rivastigmine Patch 9.5 cm2
University of California, San Francisco
Published on BioPortfolio: 2014-08-26T22:18:57-0400
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