At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- [18F] AV-133 PET Imaging (drug)
- How long the study runs
- Study runs about 50 months (dates as stated)
- About the drug or intervention
- [18F] AV-133 PET Imaging — drug: Prodromal PD participants from the PPMI Clinical (002) study will be followed for up to 24 months.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, run by the Michael J. Fox Foundation for Parkinson's Research, uses a brain scan called a PET scan with a substance known as 18F-AV-133 to look at people with prodromal Parkinson's disease. Prodromal means the very early stage, before full symptoms appear. The aim is to take pictures over time to see what changes happen in the brain.
Who can take part
- Adults over 18 who have been confirmed as eligible for the PPMI (Parkinson's Progressive Markers Initiative) baseline clinical visit
- Able to give informed consent
- Men, or women who cannot become pregnant or who use very effective birth control from 14 days before until at least 24 hours after the injection of 18F-AV-133
- Women who can become pregnant must not be pregnant or breastfeeding, and must have a negative pregnancy test on the day of the scan
Who may not be able to
- People who have taken certain medicines in the month before the scan that could affect the results, including tetrabenazine, methylphenidate, reserpine, or amphetamine-type medicines
- Any other medical or mental health problem, or unusual lab test result, that the study doctor thinks would make taking part unsafe or unsuitable
What taking part involves
- • Having an injection of 18F-AV-133 and a PET scan (a type of brain imaging scan)
Time commitment: Not stated — ask the trial team about how many visits there are, how long the study lasts, and exactly what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 100
- Started
- 2023-10-30
- Last checked
- 2025-11
Plain English Summary
What is this study?
- • Testing a new treatment for prodromal parkinsons disease
- • Phase2 - 100 participants
- • The study is a longitudinal, multi-center study to assess progression of \[18F\] AV-133 imaging in Prodromal PD participants
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with prodromal parkinsons disease
Where?
- • London - Queen Mary University of London
- • Newcastle upon Tyne - Newcastle University
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The study is a longitudinal, multi-center study to assess progression of \[18F\] AV-133 imaging in Prodromal PD participants. Participants will be followed for up to 24 months. Approximately 100 Prodromal participants will be recruited from up to 10 sites. Participants will be comprehensively assessed at baseline and follow up. Participants will undergo imaging assessments with \[18F\] AV-133 and clinical (motor, neuropsychiatric, cognitive and imaging and biomarker) assessments (conducted under the PPMI Clinical protocol).
More detail
The Parkinson's Progression Marker Initiative (PPMI) is an observational, international, multi-center study designed to identify PD progression biomarkers both to improve understanding of disease etiology and course and to provide the necessary tools to enhance the likelihood of success of therapeutics studies to slow PD progression (ClinicalTrials.gov Identifier: NCT01141023). A key focus of PPMI is to identify biomarkers during the period when PD neurodegeneration is already present, but symptoms of PD have not yet occurred. This prodromal cohort would enable us to investigate PD biomarker signatures prior to onset of typical symptoms of PD. The study is a longitudinal, multi-center study to assess progression of \[18F\]AV-133 imaging in Prodromal PD participants. The PPMI 015 study will enroll participants from the PPMI Clinical (002) study. Participants will be followed annually for up to 24 months. Approximately 100 Prodromal participants will be recruited from up to 10 sites. Participants will be comprehensively assessed at baseline and follow up. Participants will undergo \[18F\]AV-133 PET imaging targeting the vesicular monoamine transporter. All participants will undergo an initial \[18F\]AV-133 PET imaging scan at baseline with repeat imaging at 12 months and 24 months.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓A Prodromal PD participant, over the age of 18, confirmed as eligible to proceed to PPMI Clinical Baseline visit.
- ✓Able to provide agreement to take part.
- ✓Male or Female (females must meet additional criteria specified below as applicable)
- ✓Females must be of non-childbearing potential or using a highly effective method of birth control 14 days prior to...
- ✓Females of childbearing potential must not be pregnant, breastfeeding or lactating.
Who cannot take part
- ✗Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might...
See the full criteria
Where Is This Study? (2 UK sites)
Queen Mary University of London
London EC1M 6BQ, United Kingdom
Newcastle University
Newcastle upon Tyne NE45PL, United Kingdom
How to Get in Touch
Lianne Ramia
Sponsor contactCONTACT
Jessica Dimos
Sponsor contactCONTACT
