Parallel-Group Study to Assess the Effect of Rasagiline on Cognition in Patients With Parkinson's Disease
- Registration Number
- NCT01723228
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 170
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo oral tablets once daily for 24 weeks Rasagiline 1.0 mg/day Rasagiline Rasagiline 1 mg oral tablets once daily for 24 weeks
- Primary Outcome Measures
Name Time Method Mean Change From Baseline to Week 24 in the Scales for Outcomes in Parkinson's Disease-Cognition (SCOPA-COG) Summary Score Baseline to Week 24 (or early discontinuation) 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
Name Time Method Change From Baseline to Week 24 in the Montreal Cognitive Assessment (MoCA) Score Baseline to Week 24 (or early discontinuation) 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 Baseline to Week 24 (or early discontinuation) 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 Week 24 (or early discontinuation) 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 UPDRS, Activities of Daily Living (ADL) Subscale (Part 2), Version 3, Score Baseline to week 24 (or early discontinuation) 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.
Change From Baseline to Week 24 in the Unified Parkinson's Disease Rating Scale (UPDRS), Motor Subscale (Part 3), Version 3, Score Baseline to Week 24 (or early discontinuation) 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.
Trial Locations
- Locations (40)
Teva Investigational Site 003
🇺🇸Chicago, Illinois, United States
Teva Investigational Site 016
🇺🇸La Jolla, California, United States
Teva Investigational Site 004
🇺🇸Irvine, California, United States
Teva Investigational Site 038
🇺🇸Englewood, Colorado, United States
Teva Investigational Site 042
🇺🇸Long Beach, California, United States
Teva Investigational Site 033
🇺🇸Ormond Beach, Florida, United States
Teva Investigational Site 040
🇺🇸New York, New York, United States
Teva Investigational Site 015
🇺🇸Boca Raton, Florida, 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 010
🇺🇸New York, New York, United States
Teva Investigational Site 041
🇺🇸San Bernardino, California, United States
Teva Investigational Site 021
🇺🇸Jacksonville, Florida, United States
Teva Investigational Site 017
🇺🇸Saint Petersburg, Florida, United States
Teva Investigational Site 019
🇺🇸Atlanta, Georgia, United States
Teva Investigational Site 006
🇺🇸Chicago, Illinois, United States
Teva Investigational Site 009
🇺🇸Lexington, Kentucky, United States
Teva Investigational Site 025
🇺🇸Kansas City, Kansas, United States
Teva Investigational Site 024
🇺🇸Boston, Massachusetts, United States
Teva Investigational Site 045
🇺🇸Commack, New York, United States
Teva Investigational Site 014
🇺🇸Albany, New York, United States
Teva Investigational Site 013
🇺🇸Kingston, New York, United States
Teva Investigational Site 034
🇺🇸Manchester, Connecticut, United States
Teva Investigational Site 046
🇺🇸Baton Rouge, Louisiana, United States
Teva Investigational Site 047
🇺🇸Sun City, Arizona, United States
Teva Investigational Site 026
🇺🇸Washington, District of Columbia, United States
Teva Investigational Site 037
🇺🇸New London, Connecticut, United States
Teva Investigational Site 035
🇺🇸Danbury, Connecticut, United States
Teva Investigational Site 031
🇺🇸Las Vegas, Nevada, United States
Teva Investigational Site 030
🇺🇸New Brunswick, New Jersey, United States
Teva Investigational Site 020
🇺🇸Port Charlotte, Florida, United States
Teva Investigational Site 008
🇺🇸Chicago, Illinois, United States
Teva Investigational Site 028
🇺🇸Philadelphia, Pennsylvania, United States
Teva Investigational Site 001
🇺🇸La Crosse, Wisconsin, United States
Teva Investigational Site 036
🇺🇸Birmingham, Alabama, United States
Teva Investigational Site 048
🇺🇸Denver, Colorado, 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