Clinical trial NCT01723228: Parallel-Group Study to Assess the Effect of Rasagiline on Cognition in Patients With Parkinson's Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease
Cognition
Rasagiline
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2012-11-07
Enrollment: 170
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Mean Change From Baseline to Week 24 in the Scales for Outcomes in Parkinson's Disease-Cognition (SCOPA-COG) Summary Score
timeFrame: Baseline to Week 24 (or early discontinuation)
Secondary outcomes:
measure: Change From Baseline to Week 24 in the Montreal Cognitive Assessment (MoCA) Score
timeFrame: Baseline to Week 24 (or early discontinuation)
measure: Change From Baseline to Week 24 in the Penn Daily Activities Questionnaire (PDAQ) Score
timeFrame: Baseline to Week 24 (or early discontinuation)
measure: Alzheimer's Disease Cooperative Study's Clinical Global Impression of Change Modified for Mild Cognitive Impairment (ADCS MCI-CGIC) Score at Week 24
timeFrame: Week 24 (or early discontinuation)
measure: Change From Baseline to Week 24 in the Unified Parkinson's Disease Rating Scale (UPDRS), Motor Subscale (Part 3), Version 3, Score
timeFrame: Baseline to Week 24 (or early discontinuation)
measure: Change From Baseline to Week 24 in UPDRS, Activities of Daily Living (ADL) Subscale (Part 2), Version 3, Score
timeFrame: Baseline to week 24 (or early discontinuation)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Teva Investigational Site 036
state: Alabama
city: Sun City
country: United States
facility: Teva Investigational Site 047
state: Arizona
city: Irvine
country: United States
facility: Teva Investigational Site 004
state: California
city: La Jolla
country: United States
facility: Teva Investigational Site 016
state: California
city: Long Beach
country: United States
facility: Teva Investigational Site 042
state: California
city: San Bernardino
country: United States
facility: Teva Investigational Site 041
state: California
city: Denver
country: United States
facility: Teva Investigational Site 048
state: Colorado
city: Englewood
country: United States
facility: Teva Investigational Site 038
state: Colorado
city: Danbury
country: United States
facility: Teva Investigational Site 035
state: Connecticut
city: Manchester
country: United States
facility: Teva Investigational Site 034
state: Connecticut
city: New London
country: United States
facility: Teva Investigational Site 037
state: Connecticut
city: Washington
country: United States
facility: Teva Investigational Site 026
state: District of Columbia
city: Boca Raton
country: United States
facility: Teva Investigational Site 015
state: Florida
city: Jacksonville
country: United States
facility: Teva Investigational Site 021
state: Florida
city: Ormond Beach
country: United States
facility: Teva Investigational Site 033
state: Florida
city: Port Charlotte
country: United States
facility: Teva Investigational Site 020
state: Florida
city: Saint Petersburg
country: United States
facility: Teva Investigational Site 017
state: Florida
city: Atlanta
country: United States
facility: Teva Investigational Site 019
state: Georgia
city: Chicago
country: United States
facility: Teva Investigational Site 003
state: Illinois
city: Chicago
country: United States
facility: Teva Investigational Site 006
state: Illinois
city: Chicago
country: United States
facility: Teva Investigational Site 008
state: Illinois
city: Kansas City
country: United States
facility: Teva Investigational Site 025
state: Kansas
city: Lexington
country: United States
facility: Teva Investigational Site 009
state: Kentucky
city: Baton Rouge
country: United States
facility: Teva Investigational Site 046
state: Louisiana
city: Boston
country: United States
facility: Teva Investigational Site 024
state: Massachusetts
city: Las Vegas
country: United States
facility: Teva Investigational Site 031
state: Nevada
city: New Brunswick
country: United States
facility: Teva Investigational Site 030
state: New Jersey
city: Albany
country: United States
facility: Teva Investigational Site 014
state: New York
city: Commack
country: United States
facility: Teva Investigational Site 045
state: New York
city: Kingston
country: United States
facility: Teva Investigational Site 013
state: New York
city: New York
country: United States
facility: Teva Investigational Site 010
state: New York
city: New York
country: United States
facility: Teva Investigational Site 040
state: New York
city: Asheville
country: United States
facility: Teva Investigational Site 022
state: North Carolina
city: Raleigh
country: United States
facility: Teva Investigational Site 005
state: North Carolina
city: Toledo
country: United States
facility: Teva Investigational Site 018
state: Ohio
city: Philadelphia
country: United States
facility: Teva Investigational Site 028
state: Pennsylvania
city: Nashville
country: United States
facility: Teva Investigational Site 012
state: Tennessee
city: San Antonio
country: United States
facility: Teva Investigational Site 002
state: Texas
city: Salt Lake City
country: United States
facility: Teva Investigational Site 011
state: Utah
city: La Crosse
country: United States
facility: Teva Investigational Site 001
state: Wisconsin
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert
role: STUDY_DIRECTOR
References:
citation: 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.