Parallel-Group Study to Assess the Effect of Rasagiline on Cognition in Patients With Parkinson's Disease



Status:Completed
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:45 - 80
Updated:4/21/2016
Start Date:November 2012
End Date:January 2015

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A 24-Week, Multicenter, Randomized, Double-blind, Placebo-Controlled, Add-on, Parallel-Group Study to Assess the Effect of Rasagiline on Cognition in Patients With Parkinson's Disease

This is a 24-week, multicenter, randomized, double-blind, placebo-controlled, add-on,
parallel-group study to evaluate the effect of rasagiline on cognitive function in adults
with mild cognitive impairment (MCI) in Parkinson's disease (PD-MCI).


Inclusion Criteria:

1. Nondemented man or woman 45 through 80 years of age with idiopathic Parkinson's
disease (PD) based on the United Kingdom (UK) Parkinson's Disease Society Brain Bank
Clinical Diagnostic Criteria

2. Hoehn and Yahr stage ≥ 1 (symptoms on only 1 side of the body) with treatment and ≤ 3
(mild-to-moderate bilateral disease; some postural instability; physically
independent)

3. Mild cognitive impairment in Parkinson's disease based on the Movement Disorder
Society (MDS) Task Force Diagnostic Criteria and the Montreal Cognitive Assessment
(MoCA) rating scale (range, 20-25, inclusive)

4. Medically stable outpatient, based on the investigator's judgment

5. The patient is on a stable dopaminergic medication regimen for ≥ 30 days before
entering the study (Screening/Baseline Visit)

6. Other inclusion criteria apply; please contact the site for more information

Exclusion Criteria:

1. Clinically relevant history of vascular disease (eg, stroke)

2. History of melanoma

3. History of deep brain stimulation (DBS)

4. Impaired hepatic function, based on the investigator's judgment

5. Psychosis or is receiving antipsychotic treatment

6. Clinically significant or unstable medical or surgical condition that may preclude
safe and complete study participation, based on the investigator's judgment

7. Other exclusion criteria apply; please contact the site for more information
We found this trial at
41
sites
Raleigh, North Carolina
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Albany, NY
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Asheville, North Carolina
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Asheville, NC
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Atlanta, GA
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Baton Rouge, Louisiana
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Baton Rouge, LA
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Birmingham, Alabama
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Birmingham, AL
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Boca Raton, Florida
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Boca Raton, FL
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Boston, Massachusetts
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Boston, MA
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Boston, Massachusetts
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Boston, MA
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Chicago, Illinois
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Chicago, IL
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Chicago, Illinois
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Chicago, IL
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Chicago, Illinois
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Chicago, IL
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Commack, New York
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Commack, NY
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Danbury, Connecticut
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Danbury, CT
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Denver, CO
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Englewood, Colorado
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Englewood, CO
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Irvine, California
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Irvine, CA
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Jacksonville, Florida
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Jacksonville, FL
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Kansas City, Kansas
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Kansas City, KS
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Kingston, New York
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Kingston, NY
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La Jolla, California
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La Jolla, CA
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LaCrosse, Wisconsin
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LaCrosse, WI
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Las Vegas, Nevada
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Las Vegas, NV
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Lexington, Kentucky
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Lexington, KY
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Long Beach, California
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Long Beach, CA
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Manchester, Connecticut
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Manchester, CT
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Nashville, Tennessee
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Nashville, TN
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New Brunswick, New Jersey
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New Brunswick, NJ
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New London, Connecticut
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New London, CT
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New York, New York
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New York, NY
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New York, New York
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Ormond Beach, Florida
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Ormond Beach, FL
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Philadephia, Pennsylvania
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Philadephia, PA
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Port Charlotte, Florida
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Port Charlotte, FL
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Salt Lake City, Utah
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Salt Lake City, UT
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San Antonio, Texas
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San Antonio, TX
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San Bernadino, California
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San Bernadino, CA
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St. Petersburg, Florida
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St. Petersburg, FL
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Sun City, Arizona
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Sun City, AZ
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Toledo, OH
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Washington, District of Columbia
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Washington,
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