Mild Cognitive Impairment in Parkinson's Disease

NCT01519271 | Completed Phase 4 Results

• 1 other identifier: 813803
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease; Mild Cognitive Impairment

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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: 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.

  The ADCS-CGIC will be administered at the end of each study phase.

Secondary Outcomes (1)

• Montreal Cognitive Assessment (MoCA)

  The MoCA was administered in the beginning and end of each study phase.

Study Arms (2)

Placebo Patch

PLACEBO COMPARATOR

Drug: Placebo Patches

Exelon Patch (rivastigmine transdermal system)

ACTIVE COMPARATOR

Drug: Exelon Patch (rivastigmine transdermal system)

Interventions

Exelon Patch (rivastigmine transdermal system) DRUG

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 )

Exelon Patch (rivastigmine transdermal system)

Placebo Patches DRUG

The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine).

Placebo Patch

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Active suicide ideation.
• Weighing less than 100 lbs (45 kgs).
• History of Deep Brain Stimulation surgery.
• Diagnosis of Dementia
• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania, Ralston House

Philadelphia, Pennsylvania, 19104, United States

Location

Related Links

• Published Study Abstract

MeSH Terms

Conditions

Parkinson Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The small sample size may have limited our power to detect a treatment effect. When the study was conducted, the maximum strength of the rivastigmine patch was 9.5 mg/24 h. Since then, a higher dose has been approved by the FDA.

Results Point of Contact

• Title: Daniel Weintraub, MD
• Organization: University of Pennsylvania

Daniel.Weintraub@UPHS.UPENN.EDU

215-349-8207

Study Officials

• Daniel Weintraub, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2012
• First Posted: January 26, 2012
• Study Start: December 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: April 7, 2017
• Results First Posted: April 7, 2017

Record last verified: 2017-02

Locations

US (1)