Effects of Exenatide on Motor Function and the Brain
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|ClinicalTrials.gov Identifier: NCT03456687|
Recruitment Status : Active, not recruiting
First Posted : March 7, 2018
Last Update Posted : June 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Drug: Exenatide||Phase 1|
Participants will receive baseline testing to confirm a diagnosis of Parkinson's Disease and to determine eligibility in the research study. All of the participants in this study will receive the study drug (Exenatide). The study drug will be provided at the end of the first visit, and participants will be administered the drug once per week for the duration of the study (1 year).
During the research study the following test may occur: (1) questionnaires about quality of life and depression; (2) tests to measure strength and motor function; (3) tests to measure cognition; (4) orientation session to learn a precision gripping task; (5) functional MRI scan of the brain; (6) structural MRI scan of the brain.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Exenatide on Motor Function and the Brain|
|Actual Study Start Date :||June 5, 2018|
|Actual Primary Completion Date :||October 16, 2020|
|Estimated Study Completion Date :||May 2022|
This group will receive a weekly Exenatide 2mg injection for one year.
Exenatide will be administered through a subcutaneous injection once per week for the duration of the study (1 year).
- Change in free-water accumulation in the substantia nigra [ Time Frame: Baseline and one-year ]12-month study in PD to watch the effect of Exenatide on the progressive increase of free-water accumulation in the substantia nigra.
- Change in blood oxygen level-dependent(BOLD) signal in the posterior putamen. [ Time Frame: Baseline and one-year ]12-month study in PD to watch the effect of Exenatide on BOLD signal in the posterior putamen.
- Change in blood oxygen level-dependent(BOLD) signal in M1. [ Time Frame: Baseline and one-year ]12-month study in PD to watch the effect of Exenatide on BOLD signal in M1.
- Change in blood oxygen level-dependent(BOLD) signal in the supplementary motor area(SMA). [ Time Frame: Baseline and one-year ]12-month study in PD to watch the effect of Exenatide on BOLD signal in the SMA.
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): NCT03456687
|United States, Florida|
|Laboratory for Rehabilitation Neuroscience|
|Gainesville, Florida, United States, 32611|
|Principal Investigator:||David Vaillancourt, PhD||University of Florida|