The Effects of the Rivastigmine Patch on Parkinson's Disease With Memory and/or Thinking Problems
This is an open-label study to investigate the effects of the rivastigmine patch on attention and behavior in Parkinson's disease when associated with memory and/or thinking problems. Rivastigmine (also sold under the name Exelon) is an FDA approved medication used for the treatment of mild to moderate Alzheimer's Disease (AD) and memory or thinking problems 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. This is an open-label 12 week study where 15 subjects diagnosed with Parkinson's Disease who 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 people with Parkinson's disease and memory and/or thinking problems.
Parkinsons Disease With Dementia
Parkinsons Disease With Mild to Moderate Memory and/or Thinking Problems
Drug: Rivastigmine Patch 9.5 cm2
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Effects of the Rivastigmine Patch on Attention and Behavior in Parkinson's Disease With Dementia (PDD)|
- Resting state functional network activity (degree of fit in the dorsolateral frontal-parietal network) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
- The Attention Network Test (overall reaction time) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
- Fluctuations in attention (One Day Fluctuation Assessment Scale) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
- Neuropsychiatric symptoms (Neuropsychiatric Inventory total score) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
- Changes in everyday functions (Functional Assessment Questionnaire) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
- Caregiver assessment of cognitive and functional changes (Clinical Dementia Rating) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
- Assessment of depression (Geriatric Depression Scale) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
- Assessment of anxiety levels (Beck Anxiety Inventory) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
- Assessment of global decline (Clinical Global Impression of Change) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||November 2009|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
|Experimental: Rivastigmine Patch 9.5 cm2||
Drug: Rivastigmine Patch 9.5 cm2
Subjects 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 for 8 additional weeks.
Participation in this study requires four visits: a screening visit to ensure eligibility, an intial/baseline visit where the medication is distributed at a dosage lower than the optimal recommended dosage, a four week follow-up visit where the dosage of the medication is increased to the optimal amount, and a final twelve week follow up visit.
- In the screening visit the patient will undergo a neurological exam (including a review of their medical history and short physical exam), electrocardiogram ( a painless procedure that measures electrical activity of your heart), cognitive testing (such as memory and thinking tests), and a blood draw.
- At the Baseline/Initial visit the patient will receive a brief physical exam, additional cognitive testing, and an MRI scan. Afterwards, the study drug will be distributed.
- At the four week follow up visit the patient will be asked to do some abbreviated cognitive and neurological testing and the study drug will be re-distributed at the target dosage.
- At the final twelve week visit the patient will receive additional cognitive and neurological testing, and an MRI scan.
- At each visit the study partner will be asked to complete an interview and questionnaires about the patient's memory and thinking.
- Study compliance and adverse events will be reviewed every two weeks throughout the study, whether in person or over the phone.
|United States, California|
|San Francisco, California, United States, 94117|
|Principal Investigator:||Bruce Miller, M.D.||UCalifornia SF|
|Study Director:||Joel Kramer, PsyD||UCalifornia SF|