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

Teva Branded Pharmaceutical Products R&D, Inc.40 sites in 1 country170 target enrollmentNovember 2012

ConditionsParkinson's Disease

InterventionsRasagiline Placebo

DrugsRasagiline Placebo

Overview

Phase: Phase 4
Intervention: Rasagiline
Conditions: Parkinson's Disease
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Enrollment: 170
Locations: 40
Primary Endpoint: Mean Change From Baseline to Week 24 in the Scales for Outcomes in Parkinson's Disease-Cognition (SCOPA-COG) Summary Score
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

November 2012

End Date

January 2015

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Responsible Party

Sponsor

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

Arms & Interventions

Rasagiline 1.0 mg/day

Rasagiline 1 mg oral tablets once daily for 24 weeks

Intervention: Rasagiline

Placebo

Placebo oral tablets once daily for 24 weeks

Intervention: Placebo

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Change From Baseline to Week 24 in the Montreal Cognitive Assessment (MoCA) Score(Baseline to Week 24 (or early discontinuation))
Change From Baseline to Week 24 in the Penn Daily Activities Questionnaire (PDAQ) Score(Baseline to Week 24 (or early discontinuation))
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))
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))
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))