The Effects of the Rivastigmine Patch on Parkinson's Disease With Memory and/or Thinking Problems
Condition: Parkinsons Disease With Dementia; Parkinsons Disease With Mild to Moderate Memory and/or Thinking Problems
MeSH terms: Parkinson Disease; Dementia
Intervention: Rivastigmine Patch 9.5 cm2
Intervention description: 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.
Intervention MeSH terms: Rivastigmine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No
Keywords: PDD; Parkinson's Disease with Dementia; rivastigmine; rivastigmine patch; open label; Parkinson's Disease; Parkinsons Disease; memory; Exelon; Exelon Patch

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 (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.
    

Eligibility 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 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