Mild Cognitive Impairment in Parkinson's Disease
| Status: | Completed |
|---|---|
| Conditions: | Cognitive Studies, Parkinsons Disease |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 40 - 85 |
| Updated: | 2/8/2015 |
| Start Date: | December 2011 |
| End Date: | June 2014 |
| Contact: | Eugenia Mamikonyan, MS |
| Email: | Eugenia.Mamikonyan@uphs.upenn.edu |
| Phone: | 215-615-3085 |
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
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.
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.
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.
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.
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 regiment 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.
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