Mild Cognitive Impairment in Parkinson's Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Phase I 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) Phase II 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.

Official Title
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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

Conditions
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Parkinson's Disease, Mild Cognitive Impairment

Intervention / Treatment
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* Drug: Exelon Patch (rivastigmine transdermal system)
* Drug: Placebo Patches


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must be experiencing symptoms of mild cognitive impairment; this will be determined by study personnel. Participants must be on a sable medication regimen for 2 months prior to starting the study (necessary dose adjustments during the study are acceptable). Participants are capable of giving informed consent supported by not meeting Parkinson's disease Dementia criteria; this will be determined by study personnel. Exclusion Criteria: Active suicide ideation. Weighing less than 100 lbs (45 kgs). History of Deep Brain Stimulation surgery. Diagnosis of Dementia Taking certain types of medications may be an exclusion criteria, this will be reviewed with all potential participants. Females that are pregnant, planning to become pregnant, or are breastfeeding will not be included in the study. Females of childbearing potential will need to verify that they are not pregnant by a negative urine pregnancy test.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Patch<br> | Drug: Placebo Patches<br>* The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine).<br>|
| Active Comparator: Exelon Patch (rivastigmine transdermal system)<br> | Drug: Exelon Patch (rivastigmine transdermal system)<br>* 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 )<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alzheimer's Disease Cooperative Study- Clinical Global Impression Change (ADCS-CGIC) | 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. | The ADCS-CGIC will be administered at the end of each study phase. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montreal Cognitive Assessment (MoCA) | 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. | The MoCA was administered in the beginning and end of each study phase. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's Disease, Mild Cognitive Impairment, Cognition, Memory, Attention, Exelon, Rivastigmine