Overview

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

Status:
Completed
Trial end date:
2015-01-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Teva Branded Pharmaceutical Products, R&D Inc.
Treatments:
Rasagiline
Criteria
Inclusion Criteria:

1. 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

2. 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)

3. 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)

4. Medically stable outpatient, based on the investigator's judgment

5. The patient is on a stable dopaminergic medication regimen for ≥ 30 days before
entering the study (Screening/Baseline Visit)

6. Other inclusion criteria apply; please contact the site for more information

Exclusion Criteria:

1. Clinically relevant history of vascular disease (eg, stroke)

2. History of melanoma

3. History of deep brain stimulation (DBS)

4. Impaired hepatic function, based on the investigator's judgment

5. Psychosis or is receiving antipsychotic treatment

6. Clinically significant or unstable medical or surgical condition that may preclude
safe and complete study participation, based on the investigator's judgment

7. Other exclusion criteria apply; please contact the site for more information