The Effects of the Rivastigmine Patch on Parkinson's Disease With Dementia (PDD)
Summary
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.
Description
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.
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Parkinsons Disease With Dementia
Intervention
Rivastigmine Patch 9.5 cm2
Location
UCalifornia SF
San Francisco
California
United States
94117
Status
Recruiting
Source
University of California, San Francisco
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00988117
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Patch-clamp Techniques
An electrophysiologic technique for studying cells, cell membranes, and occasionally isolated organelles. All patch-clamp methods rely on a very high-resistance seal between a micropipette and a membrane; the seal is usually attained by gentle suction. The four most common variants include on-cell patch, inside-out patch, outside-out patch, and whole-cell clamp. Patch-clamp methods are commonly used to voltage clamp, that is control the voltage across the membrane and measure current flow, but current-clamp methods, in which the current is controlled and the voltage is measured, are also used.
Transdermal Patch
A medicated adhesive patch placed on the skin to deliver a specific dose of medication into the bloodstream.
Patch Tests
Skin tests in which the sensitizer is applied to a patch of cotton cloth or gauze held in place for approximately 48-72 hours. It is used for the elicitation of a contact hypersensitivity reaction.
Huntington Disease
A familial disorder inherited as an autosomal dominant trait and characterized by the onset of progressive CHOREA and DEMENTIA in the fourth or fifth decade of life. Common initial manifestations include paranoia; poor impulse control; DEPRESSION; HALLUCINATIONS; and DELUSIONS. Eventually intellectual impairment; loss of fine motor control; ATHETOSIS; and diffuse chorea involving axial and limb musculature develops, leading to a vegetative state within 10-15 years of disease onset. The juvenile variant has a more fulminant course including SEIZURES; ATAXIA; dementia; and chorea. (From Adams et al., Principles of Neurology, 6th ed, pp1060-4)
Frontotemporal Lobar Degeneration
Heterogeneous group of neurodegenerative disorders characterized by frontal and temporal lobe atrophy associated with neuronal loss, gliosis, and dementia. Patients exhibit progressive changes in social, behavioral, and/or language function. Multiple subtypes or forms are recognized based on presence or absence of TAU PROTEIN inclusions. FTLD includes three clinical syndromes: FRONTOTEMPORAL DEMENTIA, semantic dementia, and PRIMARY PROGRESSIVE NONFLUENT APHASIA.
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