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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02278588
• Other study ID #: [616856-4]
• Status: Completed
• Start date: November 2014
• Est. completion date: December 2017

Study information

• Verified date: February 2023
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Rasagiline

Locations

Country	Name	City	State
United States	University at Buffalo	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cognitive biomarkers assessed by DTI		2.5 years
Primary	Comparison of change in cognitive biomarkers with change in MMSE and MoCA scores		2.5 years
Secondary	Comparison of Baseline plasma BDNF with magnitude of change in brain cognitive biomarkers and MMSE and MoCA scores		2.5 years
Secondary	Comparison of changes in plasma BDNF with changes in brain cognitive biomarkers and MMSE and MoCA scores		2.5 years