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
1309
mi
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Albany, NY
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Asheville, North Carolina
858
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Asheville, NC
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801
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Atlanta, GA
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Baton Rouge, Louisiana
631
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Baton Rouge, LA
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Birmingham, Alabama
683
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Birmingham, AL
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Boca Raton, Florida
1299
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Boca Raton, FL
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Boston, Massachusetts
1444
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Boston, MA
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Boston, Massachusetts
1444
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Boston, MA
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Chicago, Illinois
610
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Chicago, IL
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Chicago, Illinois
610
mi
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Chicago, IL
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Chicago, Illinois
610
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Chicago, IL
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Commack, New York
1324
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Commack, NY
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Danbury, Connecticut
1317
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Danbury, CT
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409
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Denver, CO
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Englewood, Colorado
407
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Englewood, CO
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Irvine, California
1154
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Irvine, CA
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Jacksonville, Florida
1055
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Jacksonville, FL
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Kansas City, Kansas
196
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Kansas City, KS
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Kingston, New York
1291
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Kingston, NY
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La Jolla, California
1145
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La Jolla, CA
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LaCrosse, Wisconsin
629
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LaCrosse, WI
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Las Vegas, Nevada
960
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Las Vegas, NV
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Lexington, Kentucky
725
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Lexington, KY
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Long Beach, California
1172
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Long Beach, CA
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Manchester, Connecticut
1366
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Manchester, CT
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Nashville, Tennessee
619
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Nashville, TN
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New Brunswick, New Jersey
1263
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New Brunswick, NJ
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New London, Connecticut
1387
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New London, CT
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New York, New York
1286
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New York, NY
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New York, New York
1286
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New York, NY
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Ormond Beach, Florida
1126
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Ormond Beach, FL
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Philadephia, Pennsylvania
1122
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Philadephia, PA
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Port Charlotte, Florida
1178
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Port Charlotte, FL
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Raleigh, North Carolina
1068
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Raleigh, NC
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Salt Lake City, Utah
779
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Salt Lake City, UT
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San Antonio, Texas
576
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San Antonio, TX
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San Bernadino, California
1186
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San Bernadino, CA
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St. Petersburg, Florida
1117
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St. Petersburg, FL
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Sun City, Arizona
859
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Sun City, AZ
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804
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Toledo, OH
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Washington, District of Columbia
1126
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Washington,
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