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

Teva Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Parkinson's Disease

Treatments: Drug: Rasagiline; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01723228

TVP-1012/PM106

Details and patient eligibility

About

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).

Enrollment: 170 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

170 participants in 2 patient groups, including a placebo group

Rasagiline 1.0 mg/day

Experimental group

Description:

Rasagiline 1 mg oral tablets once daily for 24 weeks

Treatment:

Drug: Rasagiline

Placebo

Placebo Comparator group

Description:

Placebo oral tablets once daily for 24 weeks

Treatment:

Drug: Placebo