Phase 4
N=170
Parallel-Group Study to Assess the Effect of Rasagiline on Cognition in Patients With Parkinson's Disease
Parkinson's Disease
Bottom Line
View on ClinicalTrials.gov: NCT01723228 ↗Enrolled (actual)
170
Serious AEs
1.2%
Results posted
Mar 2016
Primary outcome: Primary: Mean Change From Baseline to Week 24 in the Scales for Outcomes in Parkinson's Disease-Cognition (SCOPA-COG) Summary Score — 1.6; 0.8 units on a scale — p=0.2204
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Rasagiline (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline to Week 24 in the Scales for Outcomes in Parkinson's Disease-Cognition (SCOPA-COG) Summary Score |
1.6; 0.8 | 0.2204 |
| SECONDARY Change From Baseline to Week 24 in the Montreal Cognitive Assessment (MoCA) Score |
0.9; 1.0 | 0.8428 |
| SECONDARY Change From Baseline to Week 24 in the Penn Daily Activities Questionnaire (PDAQ) Score |
-0.9; -0.1 | 0.4796 |
| SECONDARY Alzheimer's Disease Cooperative Study's Clinical Global Impression of Change Modified for Mild Cognitive Impairment (ADCS MCI-CGIC) Score at Week 24 |
1; 4; 9; 7; 11; 23 | 0.1148 |
| SECONDARY Change From Baseline to Week 24 in the Unified Parkinson's Disease Rating Scale (UPDRS), Motor Subscale (Part 3), Version 3, Score |
-3.7; -1.2 | 0.0151 sig |
| SECONDARY Change From Baseline to Week 24 in UPDRS, Activities of Daily Living (ADL) Subscale (Part 2), Version 3, Score |
-0.9; 1.4 | 0.0003 sig |
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).
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
Data sourced from ClinicalTrials.gov (NCT01723228). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.