The Effects of the Rivastigmine Patch on Parkinson's Disease With 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 Activity Change From Baseline to 12 Weeks [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]Fractional amplitude of low frequency fluctuations (fALFF) was used to measure brain activity. This metric is derived from task-free functional magnetic resonance imaging (fMRI) and represents the power of regional spontaneous and intrinsic brain activity at the local, voxel-wise level while the subject is at rest. More specifically, the amplitude of low-frequency fluctuations (ALFF) is the total power in the low-frequency range, and fALFF is calculated by dividing ALFF by the total power across all measurable frequencies. Whereas ALFF values increase near blood vessels and cerebrospinal fluid (CSF), likely due to pulsations in those areas, fALFF is less susceptible to artifactual signals. We measured change in these ratio scores post-treatment minus baseline and present in z-score units.
- Pre-post Change in Continuous Performance Test of Attention (Median Reaction Time) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]On the Continuous Performance Test (CPT), subjects press the spacebar quickly when they see a target image (a white star; 150 trials), and withhold response when they see a non-target image (5 randomly sampled white shapes; 150 trials). The inter-stimulus interval is randomly sampled from 1.5s, 2.5s, or 4s. Performance is measured by the median reaction time (milliseconds) on accurate target trials.
- Pre-post Change in Montreal Cognitive Assessment [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]The Montreal Cognitive Assessment (MoCA) was used as measure of global cognitive function. Total scores range from 0 (worst) to 30 (best).
|Study Start Date:||April 2010|
|Study Completion Date:||April 2011|
|Primary Completion Date:||April 2011 (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 initial/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.
- Study compliance and adverse events will be reviewed every two weeks throughout the study, whether in person or over the phone.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00988117
|United States, California|
|San Francisco, California, United States, 94117|
|Principal Investigator:||Bruce Miller, M.D.||UCalifornia SF|
|Study Director:||Joel Kramer, PsyD||UCalifornia SF|