A Double Blind Placebo Controlled Trial Evaluating Rasagiline Effects on Cognition in Parkinson's Disease Patients With Mild Cognitive Impairment Receiving Dopaminergic Therapy
NCT01497652 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 34
Last updated 2015-12-16
Summary
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.
Conditions
Interventions
- DRUG
-
Rasagiline/Placebo
Will receive placebo pills each day for the entire 14 weeks.
- DRUG
-
Rasagiline
0.5 mg for two weeks, then 1 mg for 12 weeks.
Sponsors & Collaborators
-
Teva Neuroscience, Inc.
collaborator INDUSTRY -
Georgetown University
lead OTHER
Principal Investigators
-
Fernando L Pagan, MD · Georgetown University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-01-31
- Primary Completion
- 2015-03-31
- Completion
- 2015-03-31
Countries
- United States
Study Locations
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