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CompletedNCT03456687Updated Sep 16, 2022

Effects of Exenatide on Motor Function and the Brain

A Phase 1 interventional study of Exenatide in Parkinson's Disease, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 40 Years to 77 Years. Per ClinicalTrials.gov, last updated 2022-09-16.

Sponsored by University of Florida · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Oct 2020, 6 years ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
40 Years to 77 Years
Sex
All
01

Study summary

The purpose of this research study is to investigate how the brain and motor behavior changes Parkinson's Disease (PD) over time in response to Exenatide. In previous clinical trials, PD patients have experienced symptomatic improvement on Exenatide and literature suggests it may help slow the progression of Parkinson's. Both will be evaluated in this study.

Read the detailed description

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.

02

Conditions studied

  • Parkinson's Disease

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Keywords

  • Exenatide
03

In context

Parkinson Disease

4,583 studies on the registry are indexed under Parkinson Disease; 1,097 are open to participants now.

This study's enrollment of 5 is below the median of 40 across 3,365 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

University of Florida is the lead sponsor of 1,285 studies on the registry; 199 are open to participants now.

Of its 177 completed or terminated interventional studies of FDA-regulated products, 141 (80%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 77 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • Experimental
    Exenatide

    This group will receive a weekly Exenatide 2mg injection for one year.

    Drug: Exenatide

Interventions

  • DrugExenatide

    Exenatide will be administered through a subcutaneous injection once per week for the duration of the study (1 year).

    Also known as: Bydureon, Glucagon-like peptide-1 receptor agonist

06

What researchers measure

Primary outcomes

  1. Change in free-water accumulation in the substantia nigra

    12-month study in PD to watch the effect of Exenatide on the progressive increase of free-water accumulation in the substantia nigra.

    Time frame: Baseline and one-year

  2. Change in blood oxygen level-dependent(BOLD) signal in the posterior putamen.

    12-month study in PD to watch the effect of Exenatide on BOLD signal in the posterior putamen.

    Time frame: Baseline and one-year

  3. Change in blood oxygen level-dependent(BOLD) signal in M1.

    12-month study in PD to watch the effect of Exenatide on BOLD signal in M1.

    Time frame: Baseline and one-year

  4. Change in blood oxygen level-dependent(BOLD) signal in the supplementary motor area(SMA).

    12-month study in PD to watch the effect of Exenatide on BOLD signal in the SMA.

    Time frame: Baseline and one-year

07

Study locations

1 site
  • Laboratory for Rehabilitation Neuroscience
    Gainesville, Florida 32611, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03456687
Lead sponsor
University of Florida
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Responsible party
Sponsor
First posted
Mar 7, 2018
Start date
Jun 5, 2018
Primary completion
Oct 16, 2020
Completion
Aug 25, 2021
Last update
Sep 16, 2022

Study contacts

David Vaillancourt, PhD
principal investigator · University of Florida

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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