Clinical trial NCT01519271
Conditions: Parkinson's Disease Mild Cognitive Impairment
Keywords: Parkinson's Disease Mild Cognitive Impairment Cognition Memory Attention Exelon Rivastigmine
Sponsor: University of Pennsylvania
Start date: 2011-12-01; Completion date: 2014-06-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
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:
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.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Exelon Patch (rivastigmine transdermal system) intervention 2: Placebo Patches
Intervention descriptions: intervention 1: 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 ) intervention 2: The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine).

Protocol documents: