The Effects of the Rivastigmine Patch on Parkinson's Disease With Memory and/or Thinking Problems
This study has been completed.
Sponsor:
University of California, San Francisco
Collaborator:
Novartis
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00988117
First received: September 29, 2009
Last updated: February 14, 2011
Last verified: December 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinsons Disease With Dementia Parkinsons Disease With Mild to Moderate Memory and/or Thinking Problems |
Drug: Rivastigmine Patch 9.5 cm2 |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Effects of the Rivastigmine Patch on Attention and Behavior in Parkinson's Disease With Dementia (PDD) |
Resource links provided by NLM:
Further study details as provided by University of California, San Francisco:
Primary Outcome Measures:
- Resting state functional network activity (degree of fit in the dorsolateral frontal-parietal network) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
- The Attention Network Test (overall reaction time) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
- Fluctuations in attention (One Day Fluctuation Assessment Scale) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
- Neuropsychiatric symptoms (Neuropsychiatric Inventory total score) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Changes in everyday functions (Functional Assessment Questionnaire) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
- Caregiver assessment of cognitive and functional changes (Clinical Dementia Rating) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
- Assessment of depression (Geriatric Depression Scale) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
- Assessment of anxiety levels (Beck Anxiety Inventory) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
- Assessment of global decline (Clinical Global Impression of Change) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 15 |
| Study Start Date: | November 2009 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Rivastigmine Patch 9.5 cm2 |
Drug: Rivastigmine Patch 9.5 cm2
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.
|
Detailed Description:
Participation in this study requires four visits: a screening visit to ensure eligibility, an intial/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.
- In the screening visit the patient will undergo a neurological exam (including a review of their medical history and short physical exam), electrocardiogram ( a painless procedure that measures electrical activity of your heart), cognitive testing (such as memory and thinking tests), and a blood draw.
- At the Baseline/Initial visit the patient will receive a brief physical exam, additional cognitive testing, and an MRI scan. Afterwards, the study drug will be distributed.
- At the four week follow up visit the patient will be asked to do some abbreviated cognitive and neurological testing and the study drug will be re-distributed at the target dosage.
- At the final twelve week visit the patient will receive additional cognitive and neurological testing, and an MRI scan.
- At each visit the study partner will be asked to complete an interview and questionnaires about the patient's memory and thinking.
- Study compliance and adverse events will be reviewed every two weeks throughout the study, whether in person or over the phone.
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Must meet research criteria for Parkinson's Disease with Dementia (PDD)
- Males and females, ages between 55 and 100
- Able to undergo psychometric testing
- Mini-Mental State Examination ≥ 21 and Clinical Dementia Rating < 2
- Reliable informant with frequent contact with patient
Exclusion Criteria:
- Non-English speaking, as cognitive tests will be in English
- Evidence of other neurological or psychiatric disorders which preclude diagnosis of PDD (including, but not limited to, stroke, any psychotic disorder, severe bipolar or unipolar depression, seizure disorder, or head injury with loss of consciousness) within the past year
- Concurrent treatment with any acetylcholinesterase inhibitors (including rivastigmine in pill or patch form), antipsychotic agents (excluding quetiapine in dosages of 150 mg and lower, abilify and geodon as these medications are commonly used in treatment of PD psychosis and should not affect results of study), mood stabilizers (valproate or lithium) or benzodiazepines (other than temazepam or zolpidem)
- Positive urine drug screen or suspected alcohol or substance abuse within last 1 year
- Current malignancy, or any clinically significant hematological, endocrine, cardiovascular, renal, hepatic, gastrointestinal or neurological disease. If the condition has been stable for at least the past year and is judged by the investigator not to interfere with the patient's participation in the study, the patient may be included
- Systolic blood pressure over 180 or less than 90 mm Hg. Diastolic blood pressure not greater than 105 or less than 50 mm Hg
- ECG is abnormal and judged to be clinically significant by the investigator
- Use of investigational drugs or participation in investigational drug studies within 30 days of screening
- Geriatric Depression Score score > 15/30
- Hachinski score > 4
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00988117
Locations
| United States, California | |
| UCalifornia SF | |
| San Francisco, California, United States, 94117 | |
Sponsors and Collaborators
University of California, San Francisco
Novartis
Investigators
| Principal Investigator: | Bruce Miller, M.D. | UCalifornia SF |
| Study Director: | Joel Kramer, PsyD | UCalifornia SF |
More Information
Additional Information:
No publications provided
| Responsible Party: | Bruce Miller, M.D. / Director of the Memory & Aging Center, UCSF, UCalifornia SF |
| ClinicalTrials.gov Identifier: | NCT00988117 History of Changes |
| Other Study ID Numbers: | CENA7 13D US45T |
| Study First Received: | September 29, 2009 |
| Last Updated: | February 14, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of California, San Francisco:
|
PDD Parkinson's Disease with Dementia rivastigmine rivastigmine patch open label Parkinson's Disease |
Parkinsons Disease memory Exelon Exelon Patch exelon |
Additional relevant MeSH terms:
|
Dementia Parkinson Disease Brain Diseases Central Nervous System Diseases Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Parkinsonian Disorders Basal Ganglia Diseases Movement Disorders Neurodegenerative Diseases Rivastigmine |
Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Neuroprotective Agents Protective Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013