Phase 4
N=15
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
Bottom Line
View on ClinicalTrials.gov: NCT00988117 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcome: Primary: Resting State Functional Activity Change From Baseline to 12 Weeks — 1.13; .79 z-score — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Rivastigmine Patch 9.5 cm2 (Drug)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Resting State Functional Activity Change From Baseline to 12 Weeks |
1.13; .79 | <0.01 sig |
| PRIMARY Pre-post Change in Continuous Performance Test of Attention (Median Reaction Time) |
579; 571 | <.01 sig |
| SECONDARY Pre-post Change in Montreal Cognitive Assessment |
23; 24.3 | .58 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Must meet research criteria for Parkinson's Disease with Dementia (PDD)
- Males and females, ages between 55 and 100
- Able to undergo psychometric testing
- Mini-Mental State Examination ≥ 21 and Clinical Dementia Rating 15/30
- Hachinski score > 4
Data sourced from ClinicalTrials.gov (NCT00988117). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.