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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Patch | Placebo Comparator |
| |
| Exelon Patch (rivastigmine transdermal system) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 ) |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The MoCA was administered in the beginning and end of each study phase. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Weintraub, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania, Ralston House | Philadelphia | Pennsylvania | 19104 | United States |
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| Label | URL |
|---|---|
| Published Study Abstract | View source |
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48 participants assessed for eligibility, 28 randomized (17 did not meet inclusion/exclusion criteria and 3 refused to participate after screening)
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo First Then Rivastigmine | Placebo patches placed on skin daily in Phase 1 and Rivastigmine 5-10cm2 patches in Phase 2. Each phase lasted for 10 weeks. 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). |
| FG001 | Rivastigmine First Then Placebo | 5-10cm2 rivastigmine patch daily first in phase 1 and placebo patch daily in phase 2. Each phase lasted for 10 weeks. 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1 |
| |||||||||||||
| Phase 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:
A participant scoring a 1 or 2 is considered a responder on the CGI scale. | 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. | Posted | Mean | Standard Deviation | scores on the CGIC | The ADCS-CGIC will be administered at the end of each study phase. |
|
Adverse events were recorded at every study visit post baseline (Phase 1: Week 4 and Week 10; Phase 2: Week 14, Week 18 and Week 24).
We used a modified version of the Treatment Emergent Symptom Scale (TESS) to assess psychiatric, cognitive, and motor adverse effects.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Patch | Placebo Patches: The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased Blood Pressure | Vascular disorders | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Weintraub, MD | University of Pennsylvania | 215-349-8207 | Daniel.Weintraub@UPHS.UPENN.EDU |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Placebo Patches | Drug | The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine). |
|
| NOT COMPLETED |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Placebo Patch |
Placebo Patches: The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine). |
| OG001 | Exelon Patch (Rivastigmine Transdermal System) | 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 ) |
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Score on MoCA | The MoCA was administered in the beginning and end of each study phase. |
|
|
|
|
| 0 |
| 26 |
| 9 |
| 26 |
| EG001 | Exelon Patch (Rivastigmine Transdermal System) | 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 ) | 0 | 28 | 11 | 28 |
| Pain | General disorders | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Other | General disorders | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | Systematic Assessment |
|
| Decreased Blood Pressure | Vascular disorders | Systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Insomnia | General disorders | Non-systematic Assessment |
|
| Worse Balance | Nervous system disorders | Systematic Assessment |
|
| Visual Hallucinations | Psychiatric disorders | Non-systematic Assessment |
|
| Increased "off" time | Nervous system disorders | Non-systematic Assessment |
|
| Weight Loss | General disorders | Systematic Assessment |
|
| Cognitive Impairment | General disorders | Non-systematic Assessment |
|
| Depression | General disorders | Non-systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |