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Study on How Exenatide Affects Early Parkinson's Disease Progression in Patients

Registered drug

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of the medication Exenatide on the progression of Parkinson's disease, a condition that affects movement and can cause symptoms like tremors and stiffness. The treatment being tested is called Bydureon, which is a form of Exenatide. It is administered as a prolonged-release suspension for injection, meaning it is given as a shot under the skin and releases the medication slowly over time.

The purpose of the study is to understand how Exenatide affects the brain and to see if it can help slow down the worsening of motor symptoms in people with early Parkinson's disease. Participants in the study will receive the treatment and be monitored over a period of time to observe any changes in their condition. The study will also look at the safety of long-term use of Exenatide by evaluating any side effects that may occur.

Throughout the study, participants will have regular check-ups to assess their health and the progression of their Parkinson's disease. These check-ups will include various assessments to measure physical activity and other health parameters. The study aims to provide valuable insights into the potential benefits of Exenatide for individuals with early Parkinson's disease.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initiation of treatment
The trial begins with the administration of the medication Bydureon, which contains the active substance exenatide.
The medication is provided as a powder and solvent for prolonged-release suspension for injection.
The injection is administered subcutaneously, which means it is injected under the skin.
The dosage is 2 mg, and it is administered once a week.
Step 2
Monitoring and assessments
Throughout the trial, various assessments are conducted to monitor the effects of the treatment.
Primary assessments include FDG-PET network analysis at baseline, 9 months, and 21 months.
Secondary assessments involve several scales and tests, such as MDS-UPDRS, which evaluates motor symptoms, and biofluid-based parameters at specified intervals.
Additional assessments include LEDD, PDQ-39, NMSQuest, ESS, MoCA, B-SIT, and MADRS at various time points.
Step 3
Open-label extension
Participants who successfully complete the initial phase may enter an open-label extension phase.
This phase continues to evaluate the effect of exenatide on motor-symptom progression and the rate and severity of any adverse effects.
The extension phase is divided into two parts, focusing on different aspects of treatment evaluation.
Step 4
Completion of trial
The trial is estimated to conclude by December 31, 2026.
Final assessments will be conducted to evaluate the overall impact of the treatment on disease progression.

Who can join the trial?

11 criteria

Have a diagnosis of **Parkinson's disease** according to specific medical guidelines.
The doctor believes the **Parkinson's disease** diagnosis is still correct, and the person can continue treatment.
Successfully completed the earlier part of the trial called "Effect of Exenatide on disease progression in early Parkinson's disease" and the first follow-up trial.
Can be either male or female.
Be at **Hoehn and Yahr stage 2 or less** when on medication. This means the person can move around without help during their best times on medication.
Currently taking **levodopa**, a common medication for Parkinson's disease.
No need for major changes in treatment and no significant changes in movement abilities over the past year.
Be between 25 and 80 years old.
Can take the trial medication by themselves or have someone to help them take it.
Have signed a form agreeing to participate in the trial.
Successfully completed the earlier part of the trial called "Effect of Exenatide on disease progression in early Parkinson's disease" for the first follow-up trial.

Who cannot join the trial?

6 criteria

Patients who do not have a diagnosis of Parkinson's disease cannot participate.
Patients who are not within the specified age range cannot participate. The age range is typically defined by the study, so it's important to check if you fit within it.
Patients who are part of a vulnerable population, which means groups that might need special protection, cannot participate.
Patients who are not able to stop their current dopaminergic treatment cannot participate. Dopaminergic treatment refers to medications that affect dopamine, a chemical in the brain important for movement and coordination.
Patients who have any medical condition that the study doctors think might interfere with the study cannot participate.
Patients who are not willing or able to follow the study procedures cannot participate.

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Investigated drugs

Exenatide is a medication being studied for its potential to slow down the progression of early Parkinson's disease. It is being evaluated to understand how it affects the brain and to measure its true treatment effects, separate from other Parkinson's treatments. The study also looks at how Exenatide impacts the progression of motor symptoms and assesses the rate and severity of any side effects related to long-term use.

Exenatide

What is already known about the treatment

Exenatide – Exenatide is administered via injection and is currently being studied for its effects on Parkinson's disease. It is in the clinical trial phase, with research focusing on its potential to slow disease progression. The main therapeutic indication is for Parkinson's disease, where it may help manage motor symptoms. At the molecular level, Exenatide works by mimicking the action of a natural hormone that increases insulin secretion, which may have neuroprotective effects. It is classified pharmacologically as a glucagon-like peptide-1 (GLP-1) receptor agonist.

Investigated diseases

Parkinson's disease – Parkinson's disease is a progressive neurological disorder that primarily affects movement. It is characterized by tremors, stiffness, and difficulty with balance and coordination. As the disease progresses, individuals may experience slowness of movement and a decrease in facial expressions. The condition is caused by the loss of dopamine-producing neurons in the brain. Over time, non-motor symptoms such as sleep disturbances, mood changes, and cognitive impairment may also develop. The progression of symptoms varies among individuals, and the rate of progression can differ significantly.