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The Effects of the Rivastigmine Patch on Parkinson's Disease With Dementia (PDD) - NCT00988117-94117(Clinical Trial 353378)



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City:  San Francisco
State:  
CA
Zip Code: 94117
Conditions: Parkinsons Disease With Dementia - Parkinsons Disease With Mild to Moderate Memory and/or Thinking Problems
Purpose: This is an open-label study to investigate the effects of the rivastigmine patch on attention and behavior in Parkinson's disease with Dementia (PDD). Rivastigmine is an FDA approved medication used for the treatment of mild to moderate Alzheimer's Disease (AD) and dementia 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 for the treatment of AD, but has had poor documentation when tested in PDD. This is an open-label 12 week study where 15 subjects diagnosed with PDD (people who have known Parkinson's Disease and 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 PDD.
Study summary: Upon referral to this study, subjects will undergo screening to ensure they meet inclusion criteria. At screening, participants will undergo an interview (prior medical & psychiatric history), neuropsychological testing, and physical & neurological exam, including UPDRS to measure parkinsonian symptoms and Hachinski score to measure cerebrovascular disease. At the end of the screening visit, the neurologist will evaluate whether the participant meets PDD research criteria and will also re-review the inclusion/exclusion criteria to ensure that the participants meets criteria for the study. All participants will undergo vital signs and an ECG to ensure minimal cardiovascular risk prior to receiving rivastigmine. Appropriate lab work will also be performed to exclude other potential causes of cognitive impairment. At baseline visits, participants will undergo a short neurological exam, an MRI scan, attention testing, and a detailed behavioral assessment, after which they 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. At this visit a short neurological exam will also be conducted. After 12 weeks, participants will again undergo a short neurological exam, an fMRI scan, attention testing and a behavioral assessment. Adverse events and compliance will be assessed every 2 weeks of the study. Informants will be asked to complete questionnaires regarding the primary participant at the baseline and 12 week visits.
Criteria: Inclusion Criteria: - Must meet research criteria for Parkinson's Disease with Dementia (PDD) - Males and females, ages between 55 and 85 - 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
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: August 16, 2010
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