Effects of Exenatide on Motor Function and the Brain

• Register: ClinicalTrials.gov
• Last refreshed on: 26 September 2022
• Main ID: NCT03456687
• Date of registration: 01/03/2018
• Prospective Registration: Yes
• Primary sponsor: University of Florida
• Public title: Effects of Exenatide on Motor Function and the Brain
• Scientific title: Effects of Exenatide on Motor Function and the Brain
• Date of first enrolment: June 5, 2018
• Target sample size: 5
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03456687
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: David Vaillancourt, PhD
• Affiliation: University of Florida

Key inclusion & exclusion criteria

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



Age minimum: 40 Years
Age maximum: 77 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: Exenatide

Primary Outcome(s)

Change in blood oxygen level-dependent(BOLD) signal in M1. [Time Frame: Baseline and one-year]

Change in free-water accumulation in the substantia nigra [Time Frame: Baseline and one-year]

Change in blood oxygen level-dependent(BOLD) signal in the posterior putamen. [Time Frame: Baseline and one-year]

Change in blood oxygen level-dependent(BOLD) signal in the supplementary motor area(SMA). [Time Frame: Baseline and one-year]

Secondary ID(s)

R01NS052318

IRB201703187 - N

OCR17539

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Neurological Disorders and Stroke (NINDS)