RecruitingPHASE2INTERVENTIONAL

Early Longitudinal Imaging in the Parkinson's Progressive Marker Initiative (PPMI) Using (18F)AV-133 (PPMI AV-133 Prodromal Imaging)

This study, called PPMI AV-133, is looking at how Parkinson's disease progresses in its very early stages, before noticeable symptoms appear. Researchers will use a special brain scan called a PET scan with a tracer called [18F]AV-133. This scan helps them see changes in the brain over time. Around 100 participants, who are thought to be in the early, 'prodromal' stage of Parkinson's, will be followed for up to two years. The goal is to better understand early changes in the brain and find markers that could help with future treatments to slow down the disease.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Michael J. Fox Foundation for Parkinson's Research

Enrolment target

100

Start

30 Oct 2023

Estimated completion

01 Dec 2027

Prodromal Parkinsons Disease

What is this study about?

The PPMI AV-133 study is part of a larger international effort called the Parkinson's Progression Marker Initiative (PPMI). The main goal of PPMI is to find 'biomarkers' – these are like early warning signs or indicators in the body – that can show how Parkinson's disease is developing and changing over time. Understanding these markers is really important because it could help doctors diagnose the condition earlier and develop better treatments to slow its progression.

This particular study focuses on people who are in a very early stage of Parkinson's, known as 'prodromal' Parkinson's. This means that while some early changes related to Parkinson's might be happening in their brains, they haven't yet developed the more common movement symptoms that doctors look for. By studying these individuals, researchers hope to identify changes in the brain even before symptoms appear.

To do this, participants will have a specific type of brain scan called a PET scan using a special tracing substance called [18F]AV-133. This substance helps highlight certain areas in the brain. By doing these scans over time, researchers can see how these areas might be changing and how this relates to the progression of Parkinson's disease. The information gathered will be crucial for improving our understanding of the disease and developing more effective treatments in the future.

Key takeaways

A research study looking at very early Parkinson's disease.
Uses special brain scans ([18F]AV-133 PET) to track changes over time.
Follows participants for up to two years.
Aims to find early indicators (biomarkers) of the disease.
Contributes to understanding Parkinson's progression before symptoms appear.
Does not involve experimental treatments, focuses on observation.

Who may be eligible?

To join this study, you need to be an adult (over 18 years old) who has already been confirmed as eligible for the main PPMI Clinical study (002). You must be able to understand the study and agree to take part.

If you are a woman, there are some extra requirements to ensure your safety. You must either not be able to have children (for example, if you've been through menopause or had certain surgeries) or be using a very effective method of contraception. This is because of the brain scan involved. You also cannot be pregnant or breastfeeding.

There are also some reasons you might not be able to join. For example, if you have taken certain medications that could affect the brain scan within the last month, such as tetrabenazine or methylphenidate. Additionally, if the study doctor believes that any other health condition you have might make it unsafe or difficult for you to participate, you would not be able to join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you over 18 years old?
Have you been confirmed eligible for the main PPMI Clinical study?
Are you able to agree to take part after understanding the study details?
If you are a woman, are you unable to have children, or are you using effective birth control and not pregnant/breastfeeding?
Have you avoided certain medications (like tetrabenazine, methylphenidate, reserpine, or amphetamines) for the last month?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will be followed for up to two years. You'll have a thorough check-up when you start, and then follow-up assessments each year for up to 24 months. A key part of your involvement will be having a special type of brain scan, known as an [18F]AV-133 PET scan. You will have this scan when you first join the study, and then again at 12 months and 24 months. These scans help researchers see changes in your brain over time. You will also undergo other routine clinical assessments, including checks of your movement, thinking abilities, and general health, as part of the broader PPMI Clinical protocol.

Potential risks and benefits

Taking part in research studies helps advance our understanding of diseases like Parkinson's, which could benefit others in the future. While there might not be a direct personal benefit to you from participating, your contribution is valuable. As with any medical procedure, there are potential risks associated with the PET scan, such as exposure to a small amount of radiation, similar to other medical imaging. The study team will explain these risks in detail. Remember, participation is always voluntary, and you have the right to withdraw from the study at any time without giving a reason, and it will not affect your care.

Locations (8)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Institute for Neurodegenerative Disorders
Verified postcode
New Haven, United States· Recruiting
University of Pennsylvania
Verified postcode
Philadelphia, United States· Recruiting
Toronto Western Hospital
Verified postcode
Toronto, Canada· Not yet recruiting
Philipps-University of Marburg
Verified postcode
Hessen, Germany· Not yet recruiting
Tel Aviv Sourasky Medical Center
Verified postcode
Tel Aviv, Israel· Not yet recruiting
Radboud University
Verified postcode
Nijmegen, Netherlands· Not yet recruiting
Queen Mary University of London
Verified postcode
London, United Kingdom· Recruiting
Newcastle University
Verified postcode
Newcastle upon Tyne, United Kingdom· Recruiting

Common questions

What is 'prodromal Parkinson's disease'?

This refers to the very early stage of Parkinson's when some changes related to the disease are happening in the brain, but noticeable symptoms haven't yet developed.

What is an [18F]AV-133 PET scan?

It's a special type of brain scan that uses a small amount of a safe tracing substance, [18F]AV-133, to help doctors see specific areas and changes in the brain that might be linked to Parkinson's disease.

How long will I be involved in the study?

You'll be followed for up to two years, with visits and scans typically at the start, 12 months, and 24 months.

Will this study cure or treat my Parkinson's?

This is an observational study focused on understanding the disease. It does not involve any treatment or medication with the aim of curing or treating Parkinson's.

What if I decide I don't want to continue participating?

You are free to leave the study at any time, for any reason, without it affecting your medical care.

How to find out more

Lianne Ramia

lramia1@indd.org 203-590-5600 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.