The Effect of Rasagiline on Cognition in Parkinson's Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Parkinsons Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 2/7/2015 |
| Start Date: | June 2011 |
| Contact: | Joseph Friedman, MD |
| Email: | joseph_friedman@brown.edu |
| Phone: | 401-455-6669 |
While Parkinson's disease has historically been defined in terms of its motor
symptomatology, studies have shown that non-motor deficits form an important part of the
syndrome. Cognitive deficits can occur even in the early stages of Parkinson's disease.
These deficits are often subtle and do not rise to the level of impairment necessary for a
diagnosis of dementia; however these deficits are discernable with neuropsychological
testing and may produce subjective complaints of cognitive decline and mild functional
difficulties in some patients. The traditional pharmacological interventions for Parkinson's
disease have focused on controlling and alleviating motor symptoms with levodopa and
dopamine agonists. However, these medications treat the symptoms of PD, but do not alter
the course or progression of the underlying disorder. In contrast, rasagiline, an MAO-B
inhibitor, has recently shown benefits consistent with a possible disease-modifying effect.
Given the positive and intriguing findings seen with treatment with rasagiline, the
investigators propose to study the effects of this medication on cognition in patients with
mild to moderate stage Parkinson's disease.
Hypotheses:
1. Rasagiline will improve cognitive function, as measured by performance on
neuropsychological tests in PD patients who do not suffer from dementia.
2. Rasagiline will not negatively affect neuropsychiatric functioning.
symptomatology, studies have shown that non-motor deficits form an important part of the
syndrome. Cognitive deficits can occur even in the early stages of Parkinson's disease.
These deficits are often subtle and do not rise to the level of impairment necessary for a
diagnosis of dementia; however these deficits are discernable with neuropsychological
testing and may produce subjective complaints of cognitive decline and mild functional
difficulties in some patients. The traditional pharmacological interventions for Parkinson's
disease have focused on controlling and alleviating motor symptoms with levodopa and
dopamine agonists. However, these medications treat the symptoms of PD, but do not alter
the course or progression of the underlying disorder. In contrast, rasagiline, an MAO-B
inhibitor, has recently shown benefits consistent with a possible disease-modifying effect.
Given the positive and intriguing findings seen with treatment with rasagiline, the
investigators propose to study the effects of this medication on cognition in patients with
mild to moderate stage Parkinson's disease.
Hypotheses:
1. Rasagiline will improve cognitive function, as measured by performance on
neuropsychological tests in PD patients who do not suffer from dementia.
2. Rasagiline will not negatively affect neuropsychiatric functioning.
Inclusion Criteria:
- age 40 or older
- able to speak and read English, at least 6 years of formal education
- a diagnosis of PD
- have a family member or caregiver willing to fill out study questionnaires
- Participants will have been on stable medication regimens (no new PD medications and
no changes to existing PD medication dosages) for the 4 weeks prior to study
enrollment.
- If participants are already taking other Parkinson's medications at time of study
enrollment, the dosages of these medications must remain stable throughout study
participation.
- Changes to existing Parkinson's disease medications dosages or addition of other
medications to treat Parkinson's disease after study enrollment will result in
removal from study.
- Participants are allowed to begin non-PD medications or to have changes to their
existing non-PD medications if these additions and changes are deemed medically
necessary.
Exclusion Criteria:
- currently taking any MAO inhibitor
- currently taking a cognition-enhancing medication such as a cholinesterase inhibitor
medication or memantine
- dementia (Mini-Mental Status Exam score below 21/30), significant depression (Beck
Depression Inventory- Short Form score >7)
- presence of a another neurodegenerative disorder besides PD
- unstable cardiac disorder, clinically significant hepatic
- lung or renal disease
- In addition, changes to dosages of PD-related medications or the addition of other PD
medications during the 6 month study enrollment will result in dismissal from the
study.
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