Effects of Exenatide on Motor Function and the Brain

• Status: Active, not recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)
• Treatments: Exenatide; Glucagon; Glucagon-Like Peptide 1

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