Mild Cognitive Impairment in Parkinson's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01519271
• Date of registration: 10/01/2012
• Prospective Registration: No
• Primary sponsor: University of Pennsylvania
• Public title: Mild Cognitive Impairment in Parkinson's Disease
• Scientific 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
• Date of first enrolment: December 2011
• Target sample size: 28
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01519271
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Daniel Weintraub, MD
• Affiliation: University of Pennsylvania

Key inclusion & exclusion 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.



Age minimum: 40 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Mild Cognitive Impairment

Intervention(s)

Drug: Exelon Patch (rivastigmine transdermal system)

Drug: Placebo Patches

Primary Outcome(s)

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.]

Secondary Outcome(s)

Montreal Cognitive Assessment (MoCA) [Time Frame: The MoCA was administered in the beginning and end of each study phase.]

Secondary ID(s)

813803

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 07/04/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01519271