Effects of Exenatide on Motor Function and the Brain
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ClinicalTrials.gov Identifier: NCT03456687 |
Recruitment Status :
Completed
First Posted : March 7, 2018
Last Update Posted : September 16, 2022
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Condition or disease | Intervention/treatment | Phase |
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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 |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Completion Date : | August 25, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Exenatide
This group will receive a weekly Exenatide 2mg injection for one year.
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Drug: Exenatide
Exenatide will be administered through a subcutaneous injection once per week for the duration of the study (1 year).
Other Names:
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- 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.

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Ages Eligible for Study: | 40 Years to 77 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- patients clinically diagnosed with Parkinson's disease (PD) through use of the UK PD brain bank diagnostic criteria
- early stage PD patients within 5 years of diagnosis who have never taken Exenatide for any reason
- PD patients with a Hoehn and Yahr stage less than or equal to 2 when on medication
- patients able and willing to sign informed consent.
Exclusion Criteria:
- individuals who have any type of implanted electrical device (such as a cardiac pacemaker or a neurostimulator)
- individuals with a certain type of metallic clip in the body (i.e., an aneurysm clip in the brain)
- claustrophobia
- women who are or might be pregnant and nursing mothers. Pregnancy tests will be carried out for each female subject prior to the MRI scan.
- psychiatric disorders or dementia
- other neurologic and orthopedic problems that impair hand movements and walking
- individuals actively participating in another trial of a device, drug or surgical treatment for Parkinson's disease
- individuals who have a history metalworking involving cutting processes such as grinding, filing, shaving, and threading, will need radiological clearance to participate in this study. Specifically, individuals who report a history of metalworking will be referred to Radiology at Shands University of Florida(UF) for an orbitofrontal x-ray.
- individuals who have sustained an eye injury involving metal will also be referred to Radiology at Shands UF for an orbitofrontal x-ray.
- prior stroke or brain tumor
- cognitive impairment as assessed by a Montreal Cognitive Assessment score < 23
- individuals unwilling to comply with the study procedures
- history of gallstones, digestion problems (such as gastroparesis), severe gastrointestinal disease, history of pancreatitis, a thyroid tumor or cancer, pancreas tumor, or kidney problems
- severely impaired renal function with creatinine clearance less than 30 ml/min
- hyperlipidemia defined as more than two times the upper limit of normal
- body mass index less than 18.5
- previous exposure to Exenatide
- diabetes

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 |
Responsible Party: | University of Florida |
ClinicalTrials.gov Identifier: | NCT03456687 |
Other Study ID Numbers: |
IRB201703187 - N R01NS052318 ( U.S. NIH Grant/Contract ) OCR17539 ( Other Identifier: Universiy of Florida ) |
First Posted: | March 7, 2018 Key Record Dates |
Last Update Posted: | September 16, 2022 |
Last Verified: | September 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Exenatide |
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Synucleinopathies Neurodegenerative Diseases Exenatide |
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