Exenatide Treatment in Parkinson's Disease

What Was Tested

In this phase 2 trial, researchers set out to test Exenatide for parkinson's disease.

The development of a disease-modifying therapy that delays, reverses or stops the symptom progression remains the most important unmet goal in the treatment of Parkinson's disease (PD).

Exenatide is a synthetic analogue of human GLP-1, resistant to the metabolic processes that degrade it in its naturally occurring form.

It had two arms (groups): Exenatide (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

60 actual participants took part.

It was open to people of any sex aged from 25 years up to 80 years.

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

Examples of who could join: Diagnosis of clinically probable Parkinson's disease according to the MDS clinical diagnostic criteria for PD. Males or Females. Hoehn and Yahr stage ≤ 2 in the ON medication state. This implies that all patients will be mobile without assistance during their best "ON" medication periods. Patients are on levodopa treatment. All patients will be ≥25 and ≤80 years of age.

The full record lists 8 inclusion and 27 exclusion criteria; among the exclusions: already actively participating in a trial of a device, drug or surgical treatment for parkinson's disease; previous exposure to exenatide; known abnormality on ct or mri brain imaging considered likely to compromise compliance with trial protocol/fdg-pet acquisition.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Because people in this Exenatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the parkinson's disease participants stayed in one arm throughout.

Blinding on both sides kept the parkinson's disease participants and researchers unaware of who received Exenatide.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2020-01-21 with completion listed for 2023-10-10.

It ran at 1 site in Sweden.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): FDG-PET network analysis (time frame: 21 months).

It also tracked 19 secondary outcomes, for example The sum score of MDS-UPDRS part 3 in ON and OFF-medication state, MDS-UPDRS part 2, MDS-UPDRS part 4, Hoehn and Yahr, Accelerometer (intensity of physical activity) and Accelerometer (steps per day).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Exenatide in 60 people with parkinson's disease.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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