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Effect of 2.5 Years of Rasagiline Therapy on Progression of Cognitive Biomarkers Assessed by MRI in Parkinson's Disease.

Sponsor
Thomas Guttuso (Other)
Overall Status
Completed
CT.gov ID
NCT02278588
Collaborator
(none)
45
Enrollment
1
Location
37
Actual Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this investigator-initiated study, we will compare changes in brain cognitive biomarkers assessed by diffusion tensor imaging over 2.5 years among 12 patients with Idiopathic Parkinson's disease (IPD) receiving rasagiline, 20 IPD patients not receiving MAO-B inhibitors and 25 age-matched healthy controls. Will also compare the changes in Mini-Mental State Exam (MMSE) and Montreal Cognitive Assessment (MoCA) scores and plasma brain-derived neurotrophic factor (BDNF) with changes in brain cognitive biomarkers in all IPD patients and HC over 2.5 years.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
45 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Effect of 2.5 Years of Rasagiline Therapy on Progression of Cognitive Biomarkers Assessed by MRI in Parkinson's Disease.
Actual Study Start Date :
Nov 1, 2014
Actual Primary Completion Date :
Dec 1, 2017
Actual Study Completion Date :
Dec 1, 2017

Arms and Interventions

Arm Intervention/Treatment
PD-R

Parkinson's disease receiving rasagiline

Drug: Rasagiline
Other Names:
  • Azilect

    		•
    PD-NMAO

    Parkinson's disease not receiving any MAO-B inhibitors
    HC

    Healthy Controls

    Outcome Measures

    Primary Outcome Measures

    1. Change in cognitive biomarkers assessed by DTI [2.5 years]

    2. Comparison of change in cognitive biomarkers with change in MMSE and MoCA scores [2.5 years]

    Secondary Outcome Measures

    1. Comparison of Baseline plasma BDNF with magnitude of change in brain cognitive biomarkers and MMSE and MoCA scores [2.5 years]

    2. Comparison of changes in plasma BDNF with changes in brain cognitive biomarkers and MMSE and MoCA scores [2.5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    IPD or HC subjects who were enrolled in a similar study about 2.5 years ago and for whom Baseline DTI data are available.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University at Buffalo Buffalo New York United States 14214

    Sponsors and Collaborators

    • Thomas Guttuso

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Thomas Guttuso, Associate Professor of Neurology, Obstetrics & Gynecology, University at Buffalo
    ClinicalTrials.gov Identifier:
    NCT02278588
    Other Study ID Numbers:
    • [616856-4]
    First Posted:
    Oct 30, 2014
    Last Update Posted:
    Apr 16, 2019
    Last Verified:
    Apr 1, 2019
    Additional relevant MeSH terms:
    Parkinson Disease
    Rasagiline

    Study Results

    No Results Posted as of Apr 16, 2019