Mild Cognitive Impairment in Parkinson's Disease

• ClinicalTrials.gov Identifier: NCT01519271
• Recruitment Status: Completed
• First Posted: January 26, 2012
• Results First Posted: April 7, 2017
• Last Update Posted: April 7, 2017
• Sponsor: University of Pennsylvania
• Information provided by (Responsible Party): University of Pennsylvania

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Parkinson's Disease; Mild Cognitive Impairment	Drug: Exelon Patch (rivastigmine transdermal system); Drug: Placebo Patches	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 28 participants
• 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
• Study Start Date: December 2011
• Actual Primary Completion Date: June 2014
• Actual Study Completion Date: June 2014

Arms and Interventions

Arm	Intervention/treatment
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 )

Outcome Measures

Primary Outcome Measures :

1. 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:

   1. = Very much improved
   2. = Much improved
   3. = Minimally improved
   4. = No change
   5. = Minimally worse
   6. = Much worse
   7. = Very much worse

   A participant scoring a 1 or 2 is considered a responder on the CGI scale.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Pennsylvania

University of Pennsylvania, Ralston House

Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

University of Pennsylvania

Investigators

• Principal Investigator: Daniel Weintraub, MD; University of Pennsylvania

More Information

Additional Information:

Published Study Abstract 

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT01519271
• Other Study ID Numbers: 813803
• First Posted: January 26, 2012
• Results First Posted: April 7, 2017
• Last Update Posted: April 7, 2017
• Last Verified: February 2017

Keywords provided by University of Pennsylvania:

Parkinson's Disease; Mild Cognitive Impairment; Cognition; Memory; Attention; Exelon; Rivastigmine

Additional relevant MeSH terms:

Parkinson Disease; Cognitive Dysfunction; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Rivastigmine; Cholinesterase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Neurotransmitter Agents; Physiological Effects of Drugs; Neuroprotective Agents; Protective Agents