Mild Cognitive Impairment, Parkinson's Disease
Conditions
Keywords
Parkinson's Disease, Mild Cognitive Impairment, Cognition, Memory, Attention, Exelon, Rivastigmine
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.
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.
Interventions
DRUGExelon 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 )
DRUGPlacebo Patches
The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine).
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alzheimer's Disease Cooperative Study- Clinical Global Impression Change (ADCS-CGIC) | 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
| Measure | Time frame | Description |
|---|---|---|
| Montreal Cognitive Assessment (MoCA) | 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. |
Countries
United States
Participant flow
Recruitment details
Potential participants were a convenience sample of PD patients primarily from the Parkinson's Disease and Movement Disorders Center at the University of Pennsylvania. Patients between the ages of 40 and 85 y with idiopathic PD for more than 2 years and reporting cognitive were screened for study participation.
Pre-assignment details
48 participants assessed for eligibility, 28 randomized (17 did not meet inclusion/exclusion criteria and 3 refused to participate after screening)
Participants by arm
| Arm | Count |
|---|---|
| Placebo Patch First Then 5-10cm2 Rivastigmine Patch Placebo Patches: The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine).
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 )
Each phase lasted 10 weeks. | 14 |
| 5-10cm2 Rivastigmine Patch First First Then Placebo Patch 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 )
Placebo Patches: The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine).
Each phase lasted 10 weeks. | 14 |
| Total | 28 |
Baseline characteristics
| Characteristic | Placebo Patch First Then 5-10cm2 Rivastigmine Patch | 5-10cm2 Rivastigmine Patch First First Then Placebo Patch | Total |
|---|---|---|---|
| Age, Continuous | 66.1 years STANDARD_DEVIATION 5.5 | 62.6 years STANDARD_DEVIATION 10.1 | 64.3 years STANDARD_DEVIATION 8.2 |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 6 Participants |
| Sex: Female, Male Male | 12 Participants | 10 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 26 | 11 / 28 |
| serious Total, serious adverse events | 0 / 26 | 0 / 28 |
Outcome results
Primary
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.
Time frame: The ADCS-CGIC will be administered at the end of each study phase.
Population: Please note this study utilized the crossover design (i.e. participants were exposed to two phases of treatment, one with placebo and one with Exelon patch). The data are comparing differences in treatment groups. Over the course of this study 2 participants discontinued study participation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Patch | Alzheimer's Disease Cooperative Study- Clinical Global Impression Change (ADCS-CGIC) | 3.92 scores on the CGIC | Standard Deviation 0.94 |
| Exelon Patch (Rivastigmine Transdermal System) | Alzheimer's Disease Cooperative Study- Clinical Global Impression Change (ADCS-CGIC) | 3.48 scores on the CGIC | Standard Deviation 0.89 |
Secondary
Montreal Cognitive Assessment (MoCA)
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.
Time frame: The MoCA was administered in the beginning and end of each study phase.
Population: Please note this study utilized the crossover design (i.e. participants were exposed to two phases of treatment, one with placebo and one with Exelon patch). The data are comparing differences in treatment groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Patch | Montreal Cognitive Assessment (MoCA) | Baseline | 25.08 Score on MoCA | Standard Deviation 2.7 |
| Placebo Patch | Montreal Cognitive Assessment (MoCA) | Week 16 | 24.73 Score on MoCA | Standard Deviation 3.7 |
| Exelon Patch (Rivastigmine Transdermal System) | Montreal Cognitive Assessment (MoCA) | Baseline | 24.93 Score on MoCA | Standard Deviation 2.5 |
| Exelon Patch (Rivastigmine Transdermal System) | Montreal Cognitive Assessment (MoCA) | Week 16 | 25.6 Score on MoCA | Standard Deviation 2.7 |