Parallel-Group Study to Assess the Effect of Rasagiline on Cognition in Patients With Parkinson's Disease

Phase 4

Completed

Conditions: Parkinson's Disease

Interventions: Drug: Placebo
Drug: Rasagiline

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

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

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 036
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Birmingham, Alabama, United States
Teva Investigational Site 047
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Sun City, Arizona, United States
Teva Investigational Site 004
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Irvine, California, United States
Teva Investigational Site 016
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La Jolla, California, United States
Teva Investigational Site 042
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Long Beach, California, United States
Teva Investigational Site 041
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San Bernardino, California, United States
Teva Investigational Site 048
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Denver, Colorado, United States
Teva Investigational Site 038
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Englewood, Colorado, United States
Teva Investigational Site 035
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Danbury, Connecticut, United States
Teva Investigational Site 034
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Manchester, Connecticut, United States
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Teva Investigational Site 036
🇺🇸Birmingham, Alabama, United States