Mild Cognitive Impairment in Parkinson's Disease
Condition: Parkinson's Disease; Mild Cognitive Impairment
MeSH terms: Parkinson Disease; Cognitive Dysfunction
Intervention: Exelon Patch (rivastigmine transdermal system); Placebo Patches
Intervention description: The Exelon Patch (rivastigmine transdermal system) is a Cholinesterase Inhibitor approved by the FDA to treat Alzheimer's and Parkinson's Disease Dementia.
5-10cm2 (4.6-9.5 mg of rivastigmine/24 hours ); The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine).
Intervention MeSH terms: Rivastigmine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 28.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Parkinson's Disease; Mild Cognitive Impairment; Cognition; Memory; Attention; Exelon; Rivastigmine

Summary:

      Mild cognitive impairment, including difficulty with solving problems, planning, attention,
      or recalling information, can be a significant problem for individuals with Parkinson's
      disease. Even mild cognitive difficulties can lead to worse functioning, quality of life,
      depression, and difficulty for caregivers. Thus, ideally treatment at this stage would
      improve both cognitive symptoms and some of the other problems associated with these
      symptoms.

      Despite the fact that mild cognitive impairment is a serious problem for Parkinson's disease
      patients little is known about how best to treat it. This study is a 24-week clinical trial
      to see if a Food and Drug Administration (FDA)-approved drug, the Exelon (rivastigmine)
      Patch, is useful in treating mild cognitive impairment in patients with Parkinson's disease.
      Currently, the Exelon (rivastigmine) Patch is FDA-approved for the treatment of mild to
      moderate dementia in Alzheimer and Parkinson's disease patients.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participants must be experiencing symptoms of mild cognitive impairment; this will be
             determined by study personnel.

          2. Participants must be on a sable medication regimen for 2 months prior to starting the
             study (necessary dose adjustments during the study are acceptable).

          3. Participants are capable of giving informed consent supported by not meeting
             Parkinson's disease Dementia criteria; this will be determined by study personnel.

        Exclusion Criteria:

          1. Active suicide ideation.

          2. Weighing less than 100 lbs (45 kgs).

          3. History of Deep Brain Stimulation surgery.

          4. Diagnosis of Dementia

          5. Taking certain types of medications may be an exclusion criteria, this will be
             reviewed with all potential participants.

          6. Females that are pregnant, planning to become pregnant, or are breastfeeding will not
             be included in the study. Females of childbearing potential will need to verify that
             they are not pregnant by a negative urine pregnancy test.