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Parkinson's DiseasePhase 4NCT01723228

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

A Phase 4 study testing Rasagiline in people with Parkinson's Disease, run by Teva Branded Pharmaceutical Products R&D, Inc. at 40 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 45 to 80 years
Conditions the study is for
Parkinson's Disease
What is being tested?
Rasagiline
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
170 participants
Where
40 sitesUnited States
Study dates
Nov 2012to Jan 2015
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

40 sites in 1 country.

40 sites in 1 country

United States40 sites

  • Teva Investigational Site 014

    Albany, New York

  • Teva Investigational Site 022

    Asheville, North Carolina

  • Teva Investigational Site 019

    Atlanta, Georgia

  • Teva Investigational Site 046

    Baton Rouge, Louisiana

  • Teva Investigational Site 036

    Birmingham, Alabama

  • Teva Investigational Site 015

    Boca Raton, Florida

  • Teva Investigational Site 024

    Boston, Massachusetts

  • Teva Investigational Site 003

    Chicago, Illinois

  • Teva Investigational Site 006

    Chicago, Illinois

  • Teva Investigational Site 008

    Chicago, Illinois

  • Teva Investigational Site 045

    Commack, New York

  • Teva Investigational Site 035

    Danbury, Connecticut

  • Teva Investigational Site 048

    Denver, Colorado

  • Teva Investigational Site 038

    Englewood, Colorado

  • Teva Investigational Site 004

    Irvine, California

  • Teva Investigational Site 021

    Jacksonville, Florida

  • Teva Investigational Site 025

    Kansas City, Kansas

  • Teva Investigational Site 013

    Kingston, New York

  • Teva Investigational Site 001

    La Crosse, Wisconsin

  • Teva Investigational Site 016

    La Jolla, California

  • Teva Investigational Site 031

    Las Vegas, Nevada

  • Teva Investigational Site 009

    Lexington, Kentucky

  • Teva Investigational Site 042

    Long Beach, California

  • Teva Investigational Site 034

    Manchester, Connecticut

  • Teva Investigational Site 012

    Nashville, Tennessee

  • Teva Investigational Site 030

    New Brunswick, New Jersey

  • Teva Investigational Site 037

    New London, Connecticut

  • Teva Investigational Site 010

    New York, New York

  • Teva Investigational Site 040

    New York, New York

  • Teva Investigational Site 033

    Ormond Beach, Florida

  • Teva Investigational Site 028

    Philadelphia, Pennsylvania

  • Teva Investigational Site 020

    Port Charlotte, Florida

  • Teva Investigational Site 005

    Raleigh, North Carolina

  • Teva Investigational Site 011

    Salt Lake City, Utah

  • Teva Investigational Site 002

    San Antonio, Texas

  • Teva Investigational Site 041

    San Bernardino, California

  • Teva Investigational Site 017

    St. Petersburg, Florida

  • Teva Investigational Site 047

    Sun City, Arizona

  • Teva Investigational Site 018

    Toledo, Ohio

  • Teva Investigational Site 026

    Washington D.C., District of Columbia

Other trials in United States

About this study

Official 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

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).

Being tested
Rasagiline, Placebo
Keywords
Parkinson's Disease, Cognition, Rasagiline
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RasagilineDrug

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

  • PlaceboDrug

Study groups in NCT01723228
Study groupRoleWhat they receive
Rasagiline 1.0 mg/dayExperimentalRasagiline 1 mg oral tablets once daily for 24 weeks
Receives: Drug: Rasagiline
PlaceboPlacebo comparatorPlacebo oral tablets once daily for 24 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to Week 24 (or early discontinuation)

Secondary outcomes (5)

  1. 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).

    Measured: Baseline to Week 24 (or early discontinuation)

  2. 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).

    Measured: Baseline to Week 24 (or early discontinuation)

  3. 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.'

    Measured: Week 24 (or early discontinuation)

  4. 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.

    Measured: Baseline to Week 24 (or early discontinuation)

  5. 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.

    Measured: Baseline to week 24 (or early discontinuation)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2012 (estimated)
  2. Study startNov 2012
  3. Primary completionJan 2015
  4. Study completionJan 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01723228
Sponsor's protocol ID
TVP-1012/PM106
Status last verified
Nov 2021
First submitted
5 Nov 2012
Last updated
9 Nov 2021
Data monitoring committee
No

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.

    PubMed 21500280

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Rasagiline in people with Parkinson's Disease, run by Teva Branded Pharmaceutical Products R&D, Inc. at 40 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01723228, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021.

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