Current partner codePEPTIDESDE
NCT03456687·Phase 1·INTERVENTIONAL

Effects of Exenatide on Motor Function and the Brain

Status

Completed

Phase

Phase 1

Enrollment

5

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

DRUG

Exenatide

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

Timeline

From registration to results.

  1. First posted

    Mar 7, 2018

  2. Study start

    Jun 5, 2018

  3. Primary completion

    Oct 16, 2020

  4. Study completion

    Aug 25, 2021

  5. Results posted

    Not reported

  6. Registry updated

    Sep 16, 2022

Outcomes

What the study measures.

Primary outcomes

Change in free-water accumulation in the substantia nigra

Time frame · Baseline and one-year

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

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

Time frame · Baseline and one-year

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

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

Time frame · Baseline and one-year

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

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

Time frame · Baseline and one-year

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

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
40 Years
Maximum age
77 Years
Sex
ALL
Healthy volunteers
No

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

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Laboratory for Rehabilitation Neuroscience

Gainesville, Florida, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Exenatide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.