Effects of Exenatide on Motor Function and the Brain

NCT ID: NCT03456687

Last Updated: 2022-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-05
• Study Completion Date: 2021-08-25

Brief 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.

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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exenatide

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

Group Type: EXPERIMENTAL

Exenatide

Intervention Type: DRUG

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

Interventions

Exenatide

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

Intervention Type: DRUG

Other Intervention Names

Bydureon; Glucagon-like peptide-1 receptor agonist

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 77 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Vaillancourt, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

Laboratory for Rehabilitation Neuroscience

Gainesville, Florida, United States

Countries

United States

Other Identifiers

R01NS052318

Identifier Type: NIH

Identifier Source: secondary_id

View Link

OCR17539

Identifier Type: OTHER

Identifier Source: secondary_id

IRB201703187 - N

Identifier Type: -

Identifier Source: org_study_id