Parallel-Group Study to Assess the Effect of Rasagiline on Cognition in Patients With Parkinson's Disease
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Rasagiline
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's Disease, Cognition, Rasagiline
Eligibility Criteria
Inclusion Criteria:
- 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
- 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)
- 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)
- Medically stable outpatient, based on the investigator's judgment
- The patient is on a stable dopaminergic medication regimen for ≥ 30 days before entering the study (Screening/Baseline Visit)
- Other inclusion criteria apply; please contact the site for more information
Exclusion Criteria:
- Clinically relevant history of vascular disease (eg, stroke)
- History of melanoma
- History of deep brain stimulation (DBS)
- Impaired hepatic function, based on the investigator's judgment
- Psychosis or is receiving antipsychotic treatment
- Clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation, based on the investigator's judgment
- Other exclusion criteria apply; please contact the site for more information
Sites / Locations
- Teva Investigational Site 036
- Teva Investigational Site 047
- Teva Investigational Site 004
- Teva Investigational Site 016
- Teva Investigational Site 042
- Teva Investigational Site 041
- Teva Investigational Site 048
- Teva Investigational Site 038
- Teva Investigational Site 035
- Teva Investigational Site 034
- Teva Investigational Site 037
- Teva Investigational Site 026
- Teva Investigational Site 015
- Teva Investigational Site 021
- Teva Investigational Site 033
- Teva Investigational Site 020
- Teva Investigational Site 017
- Teva Investigational Site 019
- Teva Investigational Site 003
- Teva Investigational Site 006
- Teva Investigational Site 008
- Teva Investigational Site 025
- Teva Investigational Site 009
- Teva Investigational Site 046
- Teva Investigational Site 024
- Teva Investigational Site 031
- Teva Investigational Site 030
- Teva Investigational Site 014
- Teva Investigational Site 045
- Teva Investigational Site 013
- Teva Investigational Site 010
- Teva Investigational Site 040
- Teva Investigational Site 022
- Teva Investigational Site 005
- Teva Investigational Site 018
- Teva Investigational Site 028
- Teva Investigational Site 012
- Teva Investigational Site 002
- Teva Investigational Site 011
- Teva Investigational Site 001
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Rasagiline 1.0 mg/day
Placebo
Arm Description
Rasagiline 1 mg oral tablets once daily for 24 weeks
Placebo oral tablets once daily for 24 weeks
Outcomes
Primary Outcome Measures
Mean Change From Baseline to Week 24 in the Scales for Outcomes in Parkinson's Disease-Cognition (SCOPA-COG) Summary Score
The SCOPA-COG consists of evaluations in 4 domains: memory, attention, executive functioning, and visuospatial functioning.Scores range from 0 to 43, with higher scores reflecting better performance.
Secondary Outcome Measures
Change From Baseline to Week 24 in the Montreal Cognitive Assessment (MoCA) Score
The MoCA assesses 8 cognitive areas: visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall, and orientation. Scores range from 0 (worst) to 30 (best).
Change From Baseline to Week 24 in the Penn Daily Activities Questionnaire (PDAQ) Score
The PDAQ is a 15-item questionnaire that assesses the patient's difficulty with activities of daily living. The total score has a range of 0 (no impairment) to 60 (severe impairment).
Alzheimer's Disease Cooperative Study's Clinical Global Impression of Change Modified for Mild Cognitive Impairment (ADCS MCI-CGIC) Score at Week 24
The ADCS MCI-CGIC score is generated in the context of a semi-structured interview and is an indication of the change in the participant's global status, cognition, behavior, and functional abilities (FA) on a 7-point scale, with the best score being 'marked improvement' and the worst being 'marked worsening.'
Change From Baseline to Week 24 in the Unified Parkinson's Disease Rating Scale (UPDRS), Motor Subscale (Part 3), Version 3, Score
UPDRS Part 3 (motor examination subscale) comprises 14 items assessing the motor disabilities of the patient at the time of the visit. The participant's speech, facial expressions, ability to arise from a chair (with arms folded), posture, gait, postural stability (retropulsion test), and body bradykinesia and hypokinesia are assessed. In addition, the following evaluations require assessment of the face, neck or extremities: tremor at rest, action or postural tremor of hands, rigidity, finger taps, hand movements (open and close), rapid alternating movements of hands (pronation and supination), and leg agility (tap heel on ground). This evaluation is performed while the participant is in the 'on' phase. Each item is assessed on a scale from 0 (normal, absent, or none) to 4 (severe impairment), which are summed to get the sub-scale score. The total scale is 0-57 with a higher score indicating more severe symptoms; a decrease in the scores indicates improvement.
Change From Baseline to Week 24 in UPDRS, Activities of Daily Living (ADL) Subscale (Part 2), Version 3, Score
UPDRS Part 2 (ADL subscale) comprises 13 items evaluating the impact of PD on patients' ADL (in both the on and off states) in the week prior to the visit. The following 13 ADL are assessed: speech, salivation, swallowing, handwriting, cutting food and handling utensils, dressing, hygiene, turning in bed and adjusting bed clothes, falling (unrelated to freezing), freezing when walking, walking, tremor, and sensory complaints related to Parkinsonism. Each item is assessed on a scale from 0 (normal, absent, or none) to 4 (severe impairment), which are summed to get the sub-scale score. The total scale is 0-52 with a higher score indicating more severe symptoms; a decrease in the scores indicates improvement.
Full Information
NCT ID
NCT01723228
First Posted
November 5, 2012
Last Updated
November 6, 2021
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01723228
Brief Title
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
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's Disease, Cognition, Rasagiline
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
170 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rasagiline 1.0 mg/day
Arm Type
Experimental
Arm Description
Rasagiline 1 mg oral tablets once daily for 24 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo oral tablets once daily for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Rasagiline
Other Intervention Name(s)
Azilect® (rasagiline [N-propargyl-1-(R)-aminoindan] mesylate), TVP-1012
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Mean Change From Baseline to Week 24 in the Scales for Outcomes in Parkinson's Disease-Cognition (SCOPA-COG) Summary Score
Description
The SCOPA-COG consists of evaluations in 4 domains: memory, attention, executive functioning, and visuospatial functioning.Scores range from 0 to 43, with higher scores reflecting better performance.
Time Frame
Baseline to Week 24 (or early discontinuation)
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 24 in the Montreal Cognitive Assessment (MoCA) Score
Description
The MoCA assesses 8 cognitive areas: visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall, and orientation. Scores range from 0 (worst) to 30 (best).
Time Frame
Baseline to Week 24 (or early discontinuation)
Title
Change From Baseline to Week 24 in the Penn Daily Activities Questionnaire (PDAQ) Score
Description
The PDAQ is a 15-item questionnaire that assesses the patient's difficulty with activities of daily living. The total score has a range of 0 (no impairment) to 60 (severe impairment).
Time Frame
Baseline to Week 24 (or early discontinuation)
Title
Alzheimer's Disease Cooperative Study's Clinical Global Impression of Change Modified for Mild Cognitive Impairment (ADCS MCI-CGIC) Score at Week 24
Description
The ADCS MCI-CGIC score is generated in the context of a semi-structured interview and is an indication of the change in the participant's global status, cognition, behavior, and functional abilities (FA) on a 7-point scale, with the best score being 'marked improvement' and the worst being 'marked worsening.'
Time Frame
Week 24 (or early discontinuation)
Title
Change From Baseline to Week 24 in the Unified Parkinson's Disease Rating Scale (UPDRS), Motor Subscale (Part 3), Version 3, Score
Description
UPDRS Part 3 (motor examination subscale) comprises 14 items assessing the motor disabilities of the patient at the time of the visit. The participant's speech, facial expressions, ability to arise from a chair (with arms folded), posture, gait, postural stability (retropulsion test), and body bradykinesia and hypokinesia are assessed. In addition, the following evaluations require assessment of the face, neck or extremities: tremor at rest, action or postural tremor of hands, rigidity, finger taps, hand movements (open and close), rapid alternating movements of hands (pronation and supination), and leg agility (tap heel on ground). This evaluation is performed while the participant is in the 'on' phase. Each item is assessed on a scale from 0 (normal, absent, or none) to 4 (severe impairment), which are summed to get the sub-scale score. The total scale is 0-57 with a higher score indicating more severe symptoms; a decrease in the scores indicates improvement.
Time Frame
Baseline to Week 24 (or early discontinuation)
Title
Change From Baseline to Week 24 in UPDRS, Activities of Daily Living (ADL) Subscale (Part 2), Version 3, Score
Description
UPDRS Part 2 (ADL subscale) comprises 13 items evaluating the impact of PD on patients' ADL (in both the on and off states) in the week prior to the visit. The following 13 ADL are assessed: speech, salivation, swallowing, handwriting, cutting food and handling utensils, dressing, hygiene, turning in bed and adjusting bed clothes, falling (unrelated to freezing), freezing when walking, walking, tremor, and sensory complaints related to Parkinsonism. Each item is assessed on a scale from 0 (normal, absent, or none) to 4 (severe impairment), which are summed to get the sub-scale score. The total scale is 0-52 with a higher score indicating more severe symptoms; a decrease in the scores indicates improvement.
Time Frame
Baseline to week 24 (or early discontinuation)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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)
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)
Medically stable outpatient, based on the investigator's judgment
The patient is on a stable dopaminergic medication regimen for ≥ 30 days before entering the study (Screening/Baseline Visit)
Other inclusion criteria apply; please contact the site for more information
Exclusion Criteria:
Clinically relevant history of vascular disease (eg, stroke)
History of melanoma
History of deep brain stimulation (DBS)
Impaired hepatic function, based on the investigator's judgment
Psychosis or is receiving antipsychotic treatment
Clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation, based on the investigator's judgment
Other exclusion criteria apply; please contact the site for more information
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teva Medical Expert
Organizational Affiliation
Teva Branded Pharmaceutical Products R&D, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Teva Investigational Site 036
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Teva Investigational Site 047
City
Sun City
State/Province
Arizona
Country
United States
Facility Name
Teva Investigational Site 004
City
Irvine
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 016
City
La Jolla
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 042
City
Long Beach
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 041
City
San Bernardino
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 048
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Teva Investigational Site 038
City
Englewood
State/Province
Colorado
Country
United States
Facility Name
Teva Investigational Site 035
City
Danbury
State/Province
Connecticut
Country
United States
Facility Name
Teva Investigational Site 034
City
Manchester
State/Province
Connecticut
Country
United States
Facility Name
Teva Investigational Site 037
City
New London
State/Province
Connecticut
Country
United States
Facility Name
Teva Investigational Site 026
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
Teva Investigational Site 015
City
Boca Raton
State/Province
Florida
Country
United States
Facility Name
Teva Investigational Site 021
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Teva Investigational Site 033
City
Ormond Beach
State/Province
Florida
Country
United States
Facility Name
Teva Investigational Site 020
City
Port Charlotte
State/Province
Florida
Country
United States
Facility Name
Teva Investigational Site 017
City
Saint Petersburg
State/Province
Florida
Country
United States
Facility Name
Teva Investigational Site 019
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Teva Investigational Site 003
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Teva Investigational Site 006
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Teva Investigational Site 008
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Teva Investigational Site 025
City
Kansas City
State/Province
Kansas
Country
United States
Facility Name
Teva Investigational Site 009
City
Lexington
State/Province
Kentucky
Country
United States
Facility Name
Teva Investigational Site 046
City
Baton Rouge
State/Province
Louisiana
Country
United States
Facility Name
Teva Investigational Site 024
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Teva Investigational Site 031
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Teva Investigational Site 030
City
New Brunswick
State/Province
New Jersey
Country
United States
Facility Name
Teva Investigational Site 014
City
Albany
State/Province
New York
Country
United States
Facility Name
Teva Investigational Site 045
City
Commack
State/Province
New York
Country
United States
Facility Name
Teva Investigational Site 013
City
Kingston
State/Province
New York
Country
United States
Facility Name
Teva Investigational Site 010
City
New York
State/Province
New York
Country
United States
Facility Name
Teva Investigational Site 040
City
New York
State/Province
New York
Country
United States
Facility Name
Teva Investigational Site 022
City
Asheville
State/Province
North Carolina
Country
United States
Facility Name
Teva Investigational Site 005
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Teva Investigational Site 018
City
Toledo
State/Province
Ohio
Country
United States
Facility Name
Teva Investigational Site 028
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Teva Investigational Site 012
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Teva Investigational Site 002
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Teva Investigational Site 011
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Teva Investigational Site 001
City
La Crosse
State/Province
Wisconsin
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21500280
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.
Results Reference
background
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Parallel-Group Study to Assess the Effect of Rasagiline on Cognition in Patients With Parkinson's Disease
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