Parallel-Group Study to Assess the Effect of Rasagiline on Cognition in Patients With Parkinson's Disease
|ClinicalTrials.gov Identifier: NCT01723228|
Recruitment Status : Completed
First Posted : November 7, 2012
Results First Posted : March 21, 2016
Last Update Posted : March 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Drug: Rasagiline Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||170 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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 Start Date :||November 2012|
|Primary Completion Date :||January 2015|
|Study Completion Date :||January 2015|
Experimental: Rasagiline 1.0 mg/day
Rasagiline 1 mg oral tablets once daily for 24 weeks
Placebo Comparator: Placebo
Placebo oral tablets once daily for 24 weeks
- Mean Change From Baseline to Week 24 in the Scales for Outcomes in Parkinson's Disease-Cognition (SCOPA-COG) Summary Score [ Time Frame: 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.
- Change From Baseline to Week 24 in the Montreal Cognitive Assessment (MoCA) Score [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 the Unified Parkinson's Disease Rating Scale (UPDRS), Motor Subscale (Part 3), Version 3, Score [ Time Frame: 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.
- Change From Baseline to Week 24 in UPDRS, Activities of Daily Living (ADL) Subscale (Part 2), Version 3, Score [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01723228
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|Study Director:||Teva Medical Expert||TEVA|