Effects of Exenatide on Motor Function and the Brain

NCT03456687 | Completed Phase 1 DMC FDA Drug

• 3 other identifiers: IRB201703187 - NR01NS052318OCR17539
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Keywords

Exenatide

Outcome Measures

Primary Outcomes (4)

• 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.

  Baseline and one-year

• 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.

  Baseline and one-year

• 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.

  Baseline and one-year

• 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.

  Baseline and one-year

Study Arms (1)

Exenatide

EXPERIMENTAL

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

Drug: Exenatide

Interventions

Exenatide DRUG

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

Exenatide

Eligibility Criteria

• Age: 40 Years - 77 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Laboratory for Rehabilitation Neuroscience

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Exenatide

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Study Officials

• David Vaillancourt, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: March 7, 2018
• Study Start: June 5, 2018
• Primary Completion: October 16, 2020
• Study Completion: August 25, 2021
• Last Updated: September 16, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)