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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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This is an open-label study to investigate the effects of the rivastigmine patch on attention and behavior in Parkinson's disease when associated with memory and/or thinking problems. Rivastigmine (also sold under the name Exelon) is an FDA approved medication used for the treatment of mild to moderate Alzheimer's Disease (AD) and memory or thinking problems due to Parkinson's disease. Recently a rivastigmine patch was developed, which has shown similar effectiveness with fewer side effects and increased caregiver preference when compared to capsules. This is an open-label 12 week study where 15 subjects diagnosed with Parkinson's Disease who have mild to moderate memory and/or thinking complaints will be treated with the rivastigmine patch at UCSF. This study also analyzes the mechanism by which the rivastigmine patch works in people with Parkinson's disease and memory and/or thinking problems.
Participation in this study requires four visits: a screening visit to ensure eligibility, an initial/baseline visit where the medication is distributed at a dosage lower than the optimal recommended dosage, a four week follow-up visit where the dosage of the medication is increased to the optimal amount, and a final twelve week follow up visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rivastigmine Patch 9.5 cm2 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivastigmine Patch 9.5 cm2 | Drug | Subjects will be started on a 5cm2/24hr rivastigmine patch. After 4 weeks, the dose will be increased to a recommended target dose of 9.5cm2/24hr patch for 8 additional weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Resting State Functional Activity Change From Baseline to 12 Weeks | Fractional amplitude of low frequency fluctuations (fALFF) was used to measure brain activity. This metric is derived from task-free functional magnetic resonance imaging (fMRI) and represents the power of regional spontaneous and intrinsic brain activity at the local, voxel-wise level while the subject is at rest. More specifically, the amplitude of low-frequency fluctuations (ALFF) is the total power in the low-frequency range, and fALFF is calculated by dividing ALFF by the total power across all measurable frequencies. Whereas ALFF values increase near blood vessels and cerebrospinal fluid (CSF), likely due to pulsations in those areas, fALFF is less susceptible to artifactual signals. We measured change in these ratio scores post-treatment minus baseline and present in z-score units. | Baseline and 12 weeks |
| Pre-post Change in Continuous Performance Test of Attention (Median Reaction Time) | On the Continuous Performance Test (CPT), subjects press the spacebar quickly when they see a target image (a white star; 150 trials), and withhold response when they see a non-target image (5 randomly sampled white shapes; 150 trials). The inter-stimulus interval is randomly sampled from 1.5s, 2.5s, or 4s. Performance is measured by the median reaction time (milliseconds) on accurate target trials. | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-post Change in Montreal Cognitive Assessment | The Montreal Cognitive Assessment (MoCA) was used as measure of global cognitive function. Total scores range from 0 (worst) to 30 (best). | Baseline and 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce Miller, M.D. | UCalifornia SF | Principal Investigator |
| Joel Kramer, PsyD | UCalifornia SF | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCalifornia SF | San Francisco | California | 94117 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23847120 | Result | Possin KL, Kang GA, Guo C, Fine EM, Trujillo AJ, Racine CA, Wilheim R, Johnson ET, Witt JL, Seeley WW, Miller BL, Kramer JH. Rivastigmine is associated with restoration of left frontal brain activity in Parkinson's disease. Mov Disord. 2013 Sep;28(10):1384-90. doi: 10.1002/mds.25575. Epub 2013 Jul 11. |
| Label | URL |
|---|---|
| Information about the Memory \& Aging Center at UCSF | View source |
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Patients were recruited from UCSF movement disorders neurologists, regional Parkinson's Disease (PD) support group meetings and advertisements in PD newsletters between 4/2010 and 1/2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rivastigmine | The Exelon patch (rivastigmine, Novartis International AG, Basel, Switzerland) was administered at a dosage of 4.6 mg/24 hours from baseline to week 4 and at 9.5 mg/24 hours from week 4 to 12. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| 4.6 mg/24 Hours From Baseline to Week 4 |
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| COMPLETED |
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| NOT COMPLETED |
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| 9.5 mg/24 Hours From Week 4 to 12 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Rivastigmine 4.6mg/24 Hours to 9.5mg/24 Hours | The Exelon patch (rivastigmine, Novartis International AG, Basel, Switzerland) was administered at a dosage of 4.6 mg/24 hours from baseline to week 4 and at 9.5 mg/24 hours from week 4 to 12. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Resting State Functional Activity Change From Baseline to 12 Weeks | Fractional amplitude of low frequency fluctuations (fALFF) was used to measure brain activity. This metric is derived from task-free functional magnetic resonance imaging (fMRI) and represents the power of regional spontaneous and intrinsic brain activity at the local, voxel-wise level while the subject is at rest. More specifically, the amplitude of low-frequency fluctuations (ALFF) is the total power in the low-frequency range, and fALFF is calculated by dividing ALFF by the total power across all measurable frequencies. Whereas ALFF values increase near blood vessels and cerebrospinal fluid (CSF), likely due to pulsations in those areas, fALFF is less susceptible to artifactual signals. We measured change in these ratio scores post-treatment minus baseline and present in z-score units. | All patients who completed the study were included. | Posted | Mean | Standard Deviation | z-score | Baseline and 12 weeks |
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| Primary | Pre-post Change in Continuous Performance Test of Attention (Median Reaction Time) | On the Continuous Performance Test (CPT), subjects press the spacebar quickly when they see a target image (a white star; 150 trials), and withhold response when they see a non-target image (5 randomly sampled white shapes; 150 trials). The inter-stimulus interval is randomly sampled from 1.5s, 2.5s, or 4s. Performance is measured by the median reaction time (milliseconds) on accurate target trials. | Data were missing for two of the patients on the CPT post-treatment due to a computer error. | Posted | Median | Full Range | milliseconds | Baseline and 12 weeks |
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| Secondary | Pre-post Change in Montreal Cognitive Assessment | The Montreal Cognitive Assessment (MoCA) was used as measure of global cognitive function. Total scores range from 0 (worst) to 30 (best). | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 weeks |
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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 | Rivastigmine 4.6mg/24 Hours | The Exelon patch (rivastigmine, Novartis International AG, Basel, Switzerland) was administered at a dosage of 4.6 mg/24 hours from baseline to week 4. | 0 | 15 | 1 | 15 | ||
| EG001 | Rivastigmine 9.5 mg/24 Hours | The Exelon patch was administered at a dosage of 9.5 mg/24 hours from week 4 to 12. | 0 | 14 | 2 | 14 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| lightheadedness | Nervous system disorders | Non-systematic Assessment | 1 subject dropped out of the study due to complaints of lightheadedness |
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| gastrointestinal distress | Gastrointestinal disorders | Non-systematic Assessment | 2 subjects dropped out of the study due to reports of gastrointestinal distress |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bruce Miller | UCaliforniaSF | 415-476-5569 | bmiller@memory.ucsf.edu; kpossin@memory.ucsf.edu |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| Superiority or Other |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Baseline |
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| Post-treatment |
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