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Looking for participantsPhase2

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

Sponsor: Michael J. Fox Foundation for Parkinson's Research

NCT ID: NCT07265596

View on ClinicalTrials.gov ↗

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.

Prodromal Parkinsons Disease

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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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

Includes a negative

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
Inclusion Criteria: 1. A Prodromal PD participant, over the age of 18, confirmed as eligible to proceed to PPMI Clinical Baseline visit. 2. Able to provide informed consent. 3. 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 until at least 24 hours after injection of 18F-AV-133 * Non-childbearing potential is defined as a female that must be either postmenopausal (no menses for at least 12 months prior to PET scan) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy). * Highly effective method of birth control is defined as practicing at least one of the following: A birth control method that results in a less than 1% per year failure rate when used consistently and correctly, such as oral contraceptives for at least 3 months prior to injection, an intrauterine device (IUD) for at least 2 months prior to injection, or barrier methods, e.g., diaphragm or combination condom and spermicide. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) is not acceptable. * Females of childbearing potential must not be pregnant, breastfeeding or lactating. * Includes a negative urine pregnancy test prior to injection of 18F-AV-133 on day of PET scan. Exclusion Criteria: 1. Received any of the following medications that might interfere with 18F- AV-133 PET imaging: tetrabenazine (TBZ) or methylphenidate, reserpine, or amphetamine derivative, within 1 month prior to the Baseline 18F-AV-133 injection. 2. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.

Where Is This Study? (2 UK sites)

Queen Mary University of London

London EC1M 6BQ, United Kingdom

Recruiting
Site contact (verified)
Cristina Simonet, MDPrincipal Investigator

Newcastle University

Newcastle upon Tyne NE45PL, United Kingdom

Recruiting
Site contact (verified)
Nicola PavesePrincipal Investigator

How to Get in Touch

Lianne Ramia

Sponsor contact

CONTACT

203-590-5600 LRamia1@indd.org

Jessica Dimos

Sponsor contact

CONTACT

203-590-5600 jdimos@indd.org
Data sourced from ClinicalTrials.gov · Last verified: 2025-11