Mild Cognitive Impairment in Parkinson's Disease
Mild cognitive impairment, including difficulty with solving problems, planning, attention, or recalling information, can be a significant problem for individuals with Parkinson's disease. Even mild cognitive difficulties can lead to worse functioning, quality of life, depression, and difficulty for caregivers. Thus, ideally treatment at this stage would improve both cognitive symptoms and some of the other problems associated with these symptoms.
Despite the fact that mild cognitive impairment is a serious problem for Parkinson's disease patients little is known about how best to treat it. This study is a 24-week clinical trial to see if a Food and Drug Administration (FDA)-approved drug, the Exelon (rivastigmine) Patch, is useful in treating mild cognitive impairment in patients with Parkinson's disease. Currently, the Exelon (rivastigmine) Patch is FDA-approved for the treatment of mild to moderate dementia in Alzheimer and Parkinson's disease patients.
|Parkinson's Disease Mild Cognitive Impairment||Drug: Exelon Patch (rivastigmine transdermal system) Drug: Placebo Patches||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase IV Randomized, Double-Blind, Placebo-Controlled, Crossover Single Site Study Of Exelon® Patch (Rivastigmine Transdermal System) For Mild Cognitive Impairment In Parkinson's Disease|
- Alzheimer's Disease Cooperative Study- Clinical Global Impression Change (ADCS-CGIC) [ Time Frame: The ADCS-CGIC will be administered at the end of each study phase. ]
The ADCS-CGIC is the most commonly used measure of global change in dementia psychopharmacology studies. This assessment is a measure of change, thus it is not appropriate for baseline administration and only administered at the end of phase visit.
The scale rates total improvement on a 7 point scale:
- = Very much improved
- = Much improved
- = Minimally improved
- = No change
- = Minimally worse
- = Much worse
- = Very much worse
A participant scoring a 1 or 2 is considered a responder on the CGI scale.
- Montreal Cognitive Assessment (MoCA) [ Time Frame: The MoCA was administered in the beginning and end of each study phase. ]The MoCA will be used as the global cognitive screening instrument. It will also be administered in the clinical trial at baseline and the final visits of each phase as a secondary outcome measure of global cognition. Scores on the MoCA range from 0-30 with 26-30 indicating normal global cognition.
|Study Start Date:||December 2011|
|Study Completion Date:||June 2014|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Placebo Patch||
Drug: Placebo Patches
The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine).
|Active Comparator: Exelon Patch (rivastigmine transdermal system)||
Drug: Exelon Patch (rivastigmine transdermal system)
The Exelon Patch (rivastigmine transdermal system) is a Cholinesterase Inhibitor approved by the FDA to treat Alzheimer's and Parkinson's Disease Dementia.
5-10cm2 (4.6-9.5 mg of rivastigmine/24 hours )
This study has 2 phases. Each phase will last 10 weeks and there will be a 4-week break between the 2 phases. Thus, you will be enrolled in the study for a total of 24 weeks. Over the course of the 24-week period we will schedule to see you in-person 6 times and check-in with you on the telephone 4 times, 2 times during each phase.
Screening (may be the same day as the baseline visit) - Research personnel will determine if you are eligible to participate in this study.
Visit 1 - Baseline Visit, Start Study Medication
Phone Call 1 - Check in to see how you are feeling after starting the study medication
Visit 2 - 4 Weeks after Baseline, Increase Study Medication if tolerated
Phone Call 2 - Check in to see how you are feeling after increasing the study medication
Visit 3/ Phase I Termination Visit - 10 Weeks after Baseline (Phase I Termination Visit)
4 Week Break (no study medication)
Visit 4/ Phase II Baseline - 14 Weeks after Baseline, Start Study Medication
Phone Call 3 - Check in to see how you are feeling after starting the study medication
Visit 5 - 18 Weeks after Baseline, Increase Study Medication
Phone Call 4 - Check in to see how you are feeling after increasing the study medication
Visit 6/Phase II and Study Termination Visit - 24 Weeks after Baseline
Visits 1, 3, 4, and 6 will last for about 2 ½ hours and visits 2 and 5 about 30 minutes. The 'check in' phone calls will last approximately 5-10 minutes.
After 24 weeks, your study participation will be over.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01519271
|United States, Pennsylvania|
|University of Pennsylvania, Ralston House|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Daniel Weintraub, MD||University of Pennsylvania|