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

NCT01723228 | Completed Phase 4 Results

• 1 other identifier: TVP-1012/PM106
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 40

Brief 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).

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease; Cognition; Rasagiline

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline to Week 24 in the Scales for Outcomes in Parkinson's Disease-Cognition (SCOPA-COG) Summary Score

  The SCOPA-COG consists of evaluations in 4 domains: memory, attention, executive functioning, and visuospatial functioning.Scores range from 0 to 43, with higher scores reflecting better performance.

  Baseline to Week 24 (or early discontinuation)

Secondary Outcomes (5)

• Change From Baseline to Week 24 in the Montreal Cognitive Assessment (MoCA) Score

  Baseline to Week 24 (or early discontinuation)

• Change From Baseline to Week 24 in the Penn Daily Activities Questionnaire (PDAQ) Score

  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

  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

  Baseline to Week 24 (or early discontinuation)

• Change From Baseline to Week 24 in UPDRS, Activities of Daily Living (ADL) Subscale (Part 2), Version 3, Score

  Baseline to week 24 (or early discontinuation)

Study Arms (2)

Rasagiline 1.0 mg/day

EXPERIMENTAL

Rasagiline 1 mg oral tablets once daily for 24 weeks

Drug: Rasagiline

Placebo

PLACEBO COMPARATOR

Placebo oral tablets once daily for 24 weeks

Drug: Placebo

Interventions

Rasagiline DRUG

Also known as: Azilect® (rasagiline [N-propargyl-1-(R)-aminoindan] mesylate), TVP-1012

Rasagiline 1.0 mg/day

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Study Sites (40)

Teva Investigational Site 036

Birmingham, Alabama, United States

Location

Teva Investigational Site 047

Sun City, Arizona, United States

Location

Teva Investigational Site 004

Irvine, California, United States

Location

Teva Investigational Site 016

La Jolla, California, United States

Location

Teva Investigational Site 042

Long Beach, California, United States

Location

Teva Investigational Site 041

San Bernardino, California, United States

Location

Teva Investigational Site 048

Denver, Colorado, United States

Location

Teva Investigational Site 038

Englewood, Colorado, United States

Location

Teva Investigational Site 035

Danbury, Connecticut, United States

Location

Teva Investigational Site 034

Manchester, Connecticut, United States

Location

Teva Investigational Site 037

New London, Connecticut, United States

Location

Teva Investigational Site 026

Washington D.C., District of Columbia, United States

Location

Teva Investigational Site 015

Boca Raton, Florida, United States

Location

Teva Investigational Site 021

Jacksonville, Florida, United States

Location

Teva Investigational Site 033

Ormond Beach, Florida, United States

Location

Teva Investigational Site 020

Port Charlotte, Florida, United States

Location

Teva Investigational Site 017

St. Petersburg, Florida, United States

Location

Teva Investigational Site 019

Atlanta, Georgia, United States

Location

Teva Investigational Site 003

Chicago, Illinois, United States

Location

Teva Investigational Site 006

Chicago, Illinois, United States

Location

Teva Investigational Site 008

Chicago, Illinois, United States

Location

Teva Investigational Site 025

Kansas City, Kansas, United States

Location

Teva Investigational Site 009

Lexington, Kentucky, United States

Location

Teva Investigational Site 046

Baton Rouge, Louisiana, United States

Location

Teva Investigational Site 024

Boston, Massachusetts, United States

Location

Teva Investigational Site 031

Las Vegas, Nevada, United States

Location

Teva Investigational Site 030

New Brunswick, New Jersey, United States

Location

Teva Investigational Site 014

Albany, New York, United States

Location

Teva Investigational Site 045

Commack, New York, United States

Location

Teva Investigational Site 013

Kingston, New York, United States

Location

Teva Investigational Site 010

New York, New York, United States

Location

Teva Investigational Site 040

New York, New York, United States

Location

Teva Investigational Site 022

Asheville, North Carolina, United States

Location

Teva Investigational Site 005

Raleigh, North Carolina, United States

Location

Teva Investigational Site 018

Toledo, Ohio, United States

Location

Teva Investigational Site 028

Philadelphia, Pennsylvania, United States

Location

Teva Investigational Site 012

Nashville, Tennessee, United States

Location

Teva Investigational Site 002

San Antonio, Texas, United States

Location

Teva Investigational Site 011

Salt Lake City, Utah, United States

Location

Teva Investigational Site 001

La Crosse, Wisconsin, United States

Location

Related Publications (1)

• Hanagasi HA, Gurvit H, Unsalan P, Horozoglu H, Tuncer N, Feyzioglu A, Gunal DI, Yener GG, Cakmur R, Sahin HA, Emre M. The effects of rasagiline on cognitive deficits in Parkinson's disease patients without dementia: a randomized, double-blind, placebo-controlled, multicenter study. Mov Disord. 2011 Aug 15;26(10):1851-8. doi: 10.1002/mds.23738. Epub 2011 Apr 15.

  PMID: 21500280 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

rasagiline; Mesylates

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products, R&D Inc.

ustevatrials@tevapharm.com

215-591-3000

Study Officials

• Teva Medical Expert

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2012
• First Posted: November 7, 2012
• Study Start: November 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: November 9, 2021
• Results First Posted: March 21, 2016

Record last verified: 2021-11

Locations

US (40)