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

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ClinicalTrials.gov Identifier: NCT02278588
Recruitment Status : Completed
First Posted : October 30, 2014
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas Guttuso, University at Buffalo

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
Parkinson's Disease Drug: Rasagiline

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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 : November 2014
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
PD-R
Parkinson's disease receiving rasagiline
Drug: Rasagiline
Other Name: Azilect

PD-NMAO
Parkinson's disease not receiving any MAO-B inhibitors
HC
Healthy Controls



Primary Outcome Measures :
  1. Change in cognitive biomarkers assessed by DTI [ Time Frame: 2.5 years ]
  2. Comparison of change in cognitive biomarkers with change in MMSE and MoCA scores [ Time Frame: 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 [ Time Frame: 2.5 years ]
  2. Comparison of changes in plasma BDNF with changes in brain cognitive biomarkers and MMSE and MoCA scores [ Time Frame: 2.5 years ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Idiopathic Parkinson's disease (IPD) and Healthy Controls (HC)
Criteria
IPD or HC subjects who were enrolled in a similar study about 2.5 years ago and for whom Baseline DTI data are available.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02278588


Locations
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United States, New York
University at Buffalo
Buffalo, New York, United States, 14214
Sponsors and Collaborators
Thomas Guttuso

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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: October 30, 2014    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Rasagiline
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs