Clinical trial NCT01519271: Mild Cognitive Impairment in Parkinson's Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson's Disease
Mild Cognitive Impairment
Keywords: Parkinson's Disease
Mild Cognitive Impairment
Cognition
Memory
Attention
Exelon
Rivastigmine
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2012-01-26
Enrollment: 28
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Participants must be experiencing symptoms of mild cognitive impairment; this will be determined by study personnel.
2. Participants must be on a sable medication regimen for 2 months prior to starting the study (necessary dose adjustments during the study are acceptable).
3. 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:

1. Active suicide ideation.
2. Weighing less than 100 lbs (45 kgs).
3. History of Deep Brain Stimulation surgery.
4. Diagnosis of Dementia
5. Taking certain types of medications may be an exclusion criteria, this will be reviewed with all potential participants.
6. 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.

Primary outcomes:
measure: Alzheimer's Disease Cooperative Study- Clinical Global Impression Change (ADCS-CGIC)
timeFrame: The ADCS-CGIC will be administered at the end of each study phase.
Secondary outcomes:
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: The MoCA was administered in the beginning and end of each study phase.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania, Ralston House
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Daniel Weintraub, MD
role: PRINCIPAL_INVESTIGATOR
References: