A Double Blind Placebo Controlled Trial Evaluating Rasagiline Effects on Cognition in Parkinson's Disease Patients Receiving Dopaminergic Therapy (RECOGNIZE)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Double Blind Placebo Controlled Trial Evaluating Rasagiline Effects on Cognition in Parkinson's Disease Patients With Mild Cognitive Imparment Receiving Dopaminergic Therapy|
- Montreal Cognitive Assessment [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]Best value is 30 and Worst Value is 0. Scores for a series of subscales are not combined for a total overall score.
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Treatment Group
Treatment group will receive Rasagiline (Azilect) 1mg daily
0.5 mg for two weeks, then 1 mg for 12 weeks.
Other Name: Azilect
Placebo Comparator: Placebo Group
will receive placebo daily
Will receive placebo pills each day for the entire 14 weeks.
Other Name: Sugar pill
Please refer to this study by its ClinicalTrials.gov identifier: NCT01497652
|Contact: Fernando L Pagan, MD||202-444-6087||Fpogan01@gunet.georgetown.edu|
|Contact: Jill G Farmer, DO||202-444-7206||Jg368@gunet.georgetown.edu|
|United States, District of Columbia|
|Georgetown University Hospital||Recruiting|
|Washington, District of Columbia, United States, 20007|
|Contact: Denise L Bartlett, RN 202-444-2658 firstname.lastname@example.org|
|Principal Investigator: Fernando L Pagan, MD|
|Principal Investigator:||Fernando L Pagan, MD||Georgetown University|