NCT02278588

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 30, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 14, 2023

Status Verified

February 1, 2023

Enrollment Period

3.1 years

First QC Date

October 28, 2014

Last Update Submit

February 10, 2023

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (2)

  • Change in cognitive biomarkers assessed by DTI

    2.5 years

  • Comparison of change in cognitive biomarkers with change in MMSE and MoCA scores

    2.5 years

Secondary Outcomes (2)

  • Comparison of Baseline plasma BDNF with magnitude of change in brain cognitive biomarkers and MMSE and MoCA scores

    2.5 years

  • Comparison of changes in plasma BDNF with changes in brain cognitive biomarkers and MMSE and MoCA scores

    2.5 years

Study Arms (3)

PD-R

Parkinson's disease receiving rasagiline

Drug: Rasagiline

PD-NMAO

Parkinson's disease not receiving any MAO-B inhibitors

HC

Healthy Controls

Interventions

RasagilineDRUG
Also known as: Azilect
PD-R

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Idiopathic Parkinson's disease (IPD) and Healthy Controls (HC)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University at Buffalo

Buffalo, New York, 14214, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

rasagiline

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Neurology, Obstetrics & Gynecology

Study Record Dates

First Submitted

October 28, 2014

First Posted

October 30, 2014

Study Start

November 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

February 14, 2023

Record last verified: 2023-02

Locations

US(1)