Parallel-Group Study to Assess the Effect of Rasagiline on Cognition in Patients With Parkinson's Disease
NCT ID: NCT01723228
Last Updated: 2021-11-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
170 participants
INTERVENTIONAL
2012-11-30
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Rasagiline 1.0 mg/day
Rasagiline 1 mg oral tablets once daily for 24 weeks
Rasagiline
Placebo
Placebo oral tablets once daily for 24 weeks
Placebo
Interventions
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Rasagiline
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion 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)
Exclusion Criteria
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
45 Years
80 Years
ALL
No
Sponsors
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Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Teva Medical Expert
Role: STUDY_DIRECTOR
Teva Branded Pharmaceutical Products R&D, Inc.
Locations
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Teva Investigational Site 036
Birmingham, Alabama, United States
Teva Investigational Site 047
Sun City, Arizona, United States
Teva Investigational Site 004
Irvine, California, United States
Teva Investigational Site 016
La Jolla, California, United States
Teva Investigational Site 042
Long Beach, California, United States
Teva Investigational Site 041
San Bernardino, California, United States
Teva Investigational Site 048
Denver, Colorado, United States
Teva Investigational Site 038
Englewood, Colorado, United States
Teva Investigational Site 035
Danbury, Connecticut, United States
Teva Investigational Site 034
Manchester, Connecticut, United States
Teva Investigational Site 037
New London, Connecticut, United States
Teva Investigational Site 026
Washington D.C., District of Columbia, United States
Teva Investigational Site 015
Boca Raton, Florida, United States
Teva Investigational Site 021
Jacksonville, Florida, United States
Teva Investigational Site 033
Ormond Beach, Florida, United States
Teva Investigational Site 020
Port Charlotte, Florida, United States
Teva Investigational Site 017
St. Petersburg, Florida, United States
Teva Investigational Site 019
Atlanta, Georgia, United States
Teva Investigational Site 003
Chicago, Illinois, United States
Teva Investigational Site 006
Chicago, Illinois, United States
Teva Investigational Site 008
Chicago, Illinois, United States
Teva Investigational Site 025
Kansas City, Kansas, United States
Teva Investigational Site 009
Lexington, Kentucky, United States
Teva Investigational Site 046
Baton Rouge, Louisiana, United States
Teva Investigational Site 024
Boston, Massachusetts, United States
Teva Investigational Site 031
Las Vegas, Nevada, United States
Teva Investigational Site 030
New Brunswick, New Jersey, United States
Teva Investigational Site 014
Albany, New York, United States
Teva Investigational Site 045
Commack, New York, United States
Teva Investigational Site 013
Kingston, New York, United States
Teva Investigational Site 010
New York, New York, United States
Teva Investigational Site 040
New York, New York, United States
Teva Investigational Site 022
Asheville, North Carolina, United States
Teva Investigational Site 005
Raleigh, North Carolina, United States
Teva Investigational Site 018
Toledo, Ohio, United States
Teva Investigational Site 028
Philadelphia, Pennsylvania, United States
Teva Investigational Site 012
Nashville, Tennessee, United States
Teva Investigational Site 002
San Antonio, Texas, United States
Teva Investigational Site 011
Salt Lake City, Utah, United States
Teva Investigational Site 001
La Crosse, Wisconsin, United States
Countries
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References
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Hanagasi HA, Gurvit H, Unsalan P, Horozoglu H, Tuncer N, Feyzioglu A, Gunal DI, Yener GG, Cakmur R, Sahin HA, Emre M. The effects of rasagiline on cognitive deficits in Parkinson's disease patients without dementia: a randomized, double-blind, placebo-controlled, multicenter study. Mov Disord. 2011 Aug 15;26(10):1851-8. doi: 10.1002/mds.23738. Epub 2011 Apr 15.
Other Identifiers
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TVP-1012/PM106
Identifier Type: -
Identifier Source: org_study_id