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

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

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).

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Drug: Placebo; Drug: Rasagiline

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States
      • Teva Investigational Site 036
  • Arizona
    • Sun City, Arizona, United States
      • Teva Investigational Site 047
  • California
    • Irvine, California, United States
      • Teva Investigational Site 004
    • La Jolla, California, United States
      • Teva Investigational Site 016
    • Long Beach, California, United States
      • Teva Investigational Site 042
    • San Bernardino, California, United States
      • Teva Investigational Site 041
  • Colorado
    • Denver, Colorado, United States
      • Teva Investigational Site 048
    • Englewood, Colorado, United States
      • Teva Investigational Site 038
  • Connecticut
    • Danbury, Connecticut, United States
      • Teva Investigational Site 035
    • Manchester, Connecticut, United States
      • Teva Investigational Site 034
    • New London, Connecticut, United States
      • Teva Investigational Site 037
  • District of Columbia
    • Washington, District of Columbia, United States
      • Teva Investigational Site 026
  • Florida
    • Boca Raton, Florida, United States
      • Teva Investigational Site 015
    • Jacksonville, Florida, United States
      • Teva Investigational Site 021
    • Ormond Beach, Florida, United States
      • Teva Investigational Site 033
    • Port Charlotte, Florida, United States
      • Teva Investigational Site 020
    • Saint Petersburg, Florida, United States
      • Teva Investigational Site 017
  • Georgia
    • Atlanta, Georgia, United States
      • Teva Investigational Site 019
  • Illinois
    • Chicago, Illinois, United States
      • Teva Investigational Site 003
    • Chicago, Illinois, United States
      • Teva Investigational Site 006
    • Chicago, Illinois, United States
      • Teva Investigational Site 008
  • Kansas
    • Kansas City, Kansas, United States
      • Teva Investigational Site 025
  • Kentucky
    • Lexington, Kentucky, United States
      • Teva Investigational Site 009
  • Louisiana
    • Baton Rouge, Louisiana, United States
      • Teva Investigational Site 046
  • Massachusetts
    • Boston, Massachusetts, United States
      • Teva Investigational Site 024
  • Nevada
    • Las Vegas, Nevada, United States
      • Teva Investigational Site 031
  • New Jersey
    • New Brunswick, New Jersey, United States
      • Teva Investigational Site 030
  • New York
    • Albany, New York, United States
      • Teva Investigational Site 014
    • Commack, New York, United States
      • Teva Investigational Site 045
    • Kingston, New York, United States
      • Teva Investigational Site 013
    • New York, New York, United States
      • Teva Investigational Site 010
    • New York, New York, United States
      • Teva Investigational Site 040
  • North Carolina
    • Asheville, North Carolina, United States
      • Teva Investigational Site 022
    • Raleigh, North Carolina, United States
      • Teva Investigational Site 005
  • Ohio
    • Toledo, Ohio, United States
      • Teva Investigational Site 018
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States
      • Teva Investigational Site 028
  • Tennessee
    • Nashville, Tennessee, United States
      • Teva Investigational Site 012
  • Texas
    • San Antonio, Texas, United States
      • Teva Investigational Site 002
  • Utah
    • Salt Lake City, Utah, United States
      • Teva Investigational Site 011
  • Wisconsin
    • La Crosse, Wisconsin, United States
      • Teva Investigational Site 001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rasagiline 1.0 mg/day; Rasagiline 1 mg oral tablets once daily for 24 weeks	Drug: Rasagiline; Other Names: TVP-1012; Azilect® (rasagiline [N-propargyl-1-(R)-aminoindan] mesylate)
Placebo Comparator: Placebo; Placebo oral tablets once daily for 24 weeks	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to Week 24 in the Montreal Cognitive Assessment (MoCA) Score	The MoCA assesses 8 cognitive areas: visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall, and orientation. Scores range from 0 (worst) to 30 (best).	Baseline to Week 24 (or early discontinuation)
Change From Baseline to Week 24 in the Penn Daily Activities Questionnaire (PDAQ) Score	The PDAQ is a 15-item questionnaire that assesses the patient's difficulty with activities of daily living. The total score has a range of 0 (no impairment) to 60 (severe impairment).	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	The ADCS MCI-CGIC score is generated in the context of a semi-structured interview and is an indication of the change in the participant's global status, cognition, behavior, and functional abilities (FA) on a 7-point scale, with the best score being 'marked improvement' and the worst being 'marked worsening.'	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	UPDRS Part 3 (motor examination subscale) comprises 14 items assessing the motor disabilities of the patient at the time of the visit. The participant's speech, facial expressions, ability to arise from a chair (with arms folded), posture, gait, postural stability (retropulsion test), and body bradykinesia and hypokinesia are assessed. In addition, the following evaluations require assessment of the face, neck or extremities: tremor at rest, action or postural tremor of hands, rigidity, finger taps, hand movements (open and close), rapid alternating movements of hands (pronation and supination), and leg agility (tap heel on ground). This evaluation is performed while the participant is in the 'on' phase. Each item is assessed on a scale from 0 (normal, absent, or none) to 4 (severe impairment), which are summed to get the sub-scale score. The total scale is 0-57 with a higher score indicating more severe symptoms; a decrease in the scores indicates improvement.	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	UPDRS Part 2 (ADL subscale) comprises 13 items evaluating the impact of PD on patients' ADL (in both the on and off states) in the week prior to the visit. The following 13 ADL are assessed: speech, salivation, swallowing, handwriting, cutting food and handling utensils, dressing, hygiene, turning in bed and adjusting bed clothes, falling (unrelated to freezing), freezing when walking, walking, tremor, and sensory complaints related to Parkinsonism. Each item is assessed on a scale from 0 (normal, absent, or none) to 4 (severe impairment), which are summed to get the sub-scale score. The total scale is 0-52 with a higher score indicating more severe symptoms; a decrease in the scores indicates improvement.	Baseline to week 24 (or early discontinuation)

Collaborators and Investigators

• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
• Investigators: Study Director: Teva Medical Expert, Teva Branded Pharmaceutical Products R&D, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: November 5, 2012
• First Submitted That Met QC Criteria: November 5, 2012
• First Posted (Estimate): November 7, 2012

Study Record Updates

• Last Update Posted (Actual): November 9, 2021
• Last Update Submitted That Met QC Criteria: November 6, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Parkinson's Disease; Cognition; Rasagiline
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Neuroprotective Agents; Protective Agents; Monoamine Oxidase Inhibitors; Rasagiline
• Other Study ID Numbers: TVP-1012/PM106