A Double Blind Placebo Controlled Trial Evaluating Rasagiline Effects on Cognition in Parkinson's Disease Patients With Mild Cognitive Impairment Receiving Dopaminergic Therapy
| Status: | Completed |
|---|---|
| Conditions: | Cognitive Studies, Parkinsons Disease |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2012 |
| End Date: | March 2015 |
The present pilot study is designed to assess the extent to which rasagiline may improve
cognition in Parkinson's disease patients requiring dopaminergic therapy. The primary
objective is to assess improvement in the Montreal Cognitive Assessment (MoCA) in patients
who have been on rasagiline at 1mg daily for twelve weeks. The secondary objective is to
assess changes in the SCOPA-COG, FAB, and UPDRS II & III at the end of week 14.
cognition in Parkinson's disease patients requiring dopaminergic therapy. The primary
objective is to assess improvement in the Montreal Cognitive Assessment (MoCA) in patients
who have been on rasagiline at 1mg daily for twelve weeks. The secondary objective is to
assess changes in the SCOPA-COG, FAB, and UPDRS II & III at the end of week 14.
Inclusion Criteria:
- Men and women aged 40 or older with idiopathic Parkinson's disease on stable
dopaminergic therapy for at least 1 month. The UK Brain Bank Criteria will be used to
establish the diagnosis of Parkinson's disease. Women must be post menopausal or
agree to avoid pregnancy. Modified Hoehn & Yahr staging < 3 and MoCA score must be
greater than 21 but less than 28. Geriatric Depression Scale (GDS) is a sensitive and
specific screen for depression in the Parkinson's disease population. GDS scores of <
5 will be included in the study.
Exclusion Criteria:
- Patients with secondary dementia, severe depression and atypical Parkinson's
syndromes or Parkinson's plus will be excluded from the study. Patients on
acetylcholine esterase or NMDA inhibitor medication will be excluded from the study.
Patients with history of brain surgery for Parkinson's disease, stroke or significant
head injury, active epilepsy will be excluded. Patients on Amantidine, neuroleptics,
metoclopramide, alphamethyldopa within the last 6 months will be excluded.
Individuals using meperidine, and tramadol will be excluded. Patients with congestive
heart failure or myocardial infarction will also be excluded to avoid vascular
dementia.
We found this trial at
1
site
3800 Reservoir Rd NW
Washington, District of Columbia 20007
Washington, District of Columbia 20007
(202) 444-2000
Georgetown University Hospital MedStar Georgetown University Hospital is a not-for-profit, acute-care teaching and research hospital...
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