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

Launched by TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. · Nov 5, 2012

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Eligibility 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