Status:
COMPLETED
The Effects of the Rivastigmine Patch on Parkinson's Disease With Memory and/or Thinking Problems
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Novartis
Conditions:
Parkinsons Disease With Dementia
Parkinsons Disease With Mild to Moderate Memory and/or Thinking Problems
Eligibility:
All Genders
55+ years
Phase:
PHASE4
Brief Summary
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 (al...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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 Parkinson's Disease (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
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00988117
Start Date
April 1 2010
End Date
April 1 2011
Last Update
February 26 2014
Active Locations (1)
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1
UCalifornia SF
San Francisco, California, United States, 94117