Phase 4
N=28
Mild Cognitive Impairment in Parkinson's Disease
Parkinson's Disease · Mild Cognitive Impairment
Bottom Line
View on ClinicalTrials.gov: NCT01519271 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Alzheimer's Disease Cooperative Study- Clinical Global Impression Change (ADCS-CGIC) — 3.92; 3.48 scores on the CGIC
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Exelon Patch (rivastigmine transdermal system) (Drug); Placebo Patches (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Alzheimer's Disease Cooperative Study- Clinical Global Impression Change (ADCS-CGIC) |
3.92; 3.48 | — |
| SECONDARY Montreal Cognitive Assessment (MoCA) |
25.08; 24.93; 24.73; 25.6 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- Active suicide ideation.
- Weighing less than 100 lbs (45 kgs).
- History of Deep Brain Stimulation surgery.
- Diagnosis of Dementia
- Taking certain types of medications may be an exclusion criteria, this will be reviewed with all potential participants.
- 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.
Data sourced from ClinicalTrials.gov (NCT01519271). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.