Effects of Exenatide on Motor Function and the Brain

What Was Tested

In this phase 1 trial, researchers set out to test Exenatide for parkinson's disease.

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.

Both will be evaluated in this study.

It had 1 arm (groups): Exenatide (experimental).

The registry classes the interventions as drug.

More on the Plan

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).

Who Took Part

5 actual participants took part.

It was open to people of any sex aged from 40 years up to 77 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 4 inclusion and 18 exclusion criteria; among the exclusions: 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); 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.

How the Study Was Run

Design: single-group and open-label.

Everyone knew when Exenatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2018-06-05 with completion listed for 2020-10-16.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: 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 M1 (time frame: Baseline and one-year).

What This Means in Plain Language

Put simply, this is a phase 1 trial of Exenatide in 5 people with parkinson's disease.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Exenatide compound page, Parkinson's disease research.