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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 15 November 2021
Main ID:  NCT01723228
Date of registration: 05/11/2012
Prospective Registration: No
Primary sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Public title: Parallel-Group Study to Assess the Effect of Rasagiline on Cognition in Patients With Parkinson's Disease
Scientific title: 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
Date of first enrolment: November 2012
Target sample size: 170
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01723228
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).  
Phase:  Phase 4
Countries of recruitment
United States
Contacts
Name:     Teva Medical Expert
Address: 
Telephone:
Email:
Affiliation:  Teva Branded Pharmaceutical Products R&D, Inc.
Key inclusion & exclusion 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



Age minimum: 45 Years
Age maximum: 80 Years
Gender: All
Health Condition(s) or Problem(s) studied
Parkinson's Disease
Intervention(s)
Drug: Placebo
Drug: Rasagiline
Primary Outcome(s)
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)]
Secondary Outcome(s)
Change From Baseline to Week 24 in UPDRS, Activities of Daily Living (ADL) Subscale (Part 2), Version 3, Score [Time Frame: 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 [Time Frame: 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 [Time Frame: Week 24 (or early discontinuation)]
Change From Baseline to Week 24 in the Penn Daily Activities Questionnaire (PDAQ) Score [Time Frame: Baseline to Week 24 (or early discontinuation)]
Change From Baseline to Week 24 in the Montreal Cognitive Assessment (MoCA) Score [Time Frame: Baseline to Week 24 (or early discontinuation)]
Secondary ID(s)
TVP-1012/PM106
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 21/03/2016
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01723228
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