Prodromal Parkinsons DiseasePhase 2NCT07265596
Early Longitudinal Imaging in the Parkinson's Progressive Marker Initiative (PPMI) Using (18F)AV-133 (PPMI AV-133 Prodromal Imaging)
A Phase 2 study testing [18F] AV-133 PET Imaging in people with Prodromal Parkinsons Disease, run by Michael J. Fox Foundation for Parkinson's Research at 8 sites in 6 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prodromal Parkinsons Disease
- What is being tested?
- [18F] AV-133 PET Imaging
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 8 sitesin 6 countries
- Study dates
- 30 Oct 2023to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A Prodromal PD participant, over the age of 18, confirmed as eligible to proceed to PPMI Clinical Baseline visit.
- Able to provide informed consent.
- 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.
Who cannot join
- 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.
- Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
Trial locations and contacts
8 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 6 countries
United States2 sites, 2 recruiting
- Recruiting
Institute for Neurodegenerative Disorders
New Haven, Connecticut, 06510
Mackenzee George Clinical Research Coordinator II, 475-318-8248, mgeorge@xingimaging.com
Amy Ruimerman Lead Clinical Research Nurse, LPN, 475-318-8208, aruimerman@xingimaging.com
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19107
PPMI Call Center, 877-525-7764
Nabila Dahodwala, MD
United Kingdom2 sites, 2 recruiting
- Recruiting
Queen Mary University of London
London, Britain, EC1M 6BQ
Cristina Simonet, 44-02078823379, c.simonet@qmul.ac.uk
Cristina Simonet, MD
- Recruiting
Newcastle University
Newcastle upon Tyne, Tyne and Wear, NE45PL
Victoria Foster, +441912081197, victoria.foster@ncl.ac.uk
Nicola Pavese
Canada1 site, 1 recruiting
- Not yet recruiting
Toronto Western Hospital
Toronto, Ontario, M5T2S8
PPMI Call Center, 877-525-7764
Connie Marras
Germany1 site, 1 recruiting
- Not yet recruiting
Philipps-University of Marburg
Hessen, 35043
Elisabeth Sittig, sittig@med.uni-marburg.de
Wolfgang Oertel
Israel1 site, 1 recruiting
- Not yet recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Anat Mirelman, Bsc972-3-697-3014, anatmi@tlvmc.gov.il
Roy Alcalay, MD
Netherlands1 site, 1 recruiting
- Not yet recruiting
Radboud University
Nijmegen, Gelderland, 6525 GC
Yara Krasowski, info@onderzoek-parkinson.nl
Bastiaan Bloem, MD
About this study
Official title: Early Longitudinal Imaging in the Parkinson's Progression Markers Initiative Using [18F] AV-133 (PPMI AV-133 Prodromal Imaging)
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).
Read the detailed description
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.
- Conditions
- Prodromal Parkinsons Disease
- Being tested
- [18F] AV-133 PET Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F] AV-133 PET ImagingDrug
Prodromal PD participants from the PPMI Clinical (002) study will be followed for up to 24 months. These participants will undergo imaging assessments with [18F]AV-133 under this protocol at baseline, 12-month and 24 months.
| Study group | Role | What they receive |
|---|---|---|
| Prodromal Parkinson's disease (PD) | Experimental | Prodromal Parkinson's disease participants enrolled in the PPMI Clinical 002 study will receive 3 injections of [18F] AV-133 and imaging procedures over the course of 24 months. Receives: Drug: [18F] AV-133 PET Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
[18F]AV-133 mean rate of change and variability
The mean rates of change and the variability around the mean of [18F]AV-133 PET SUVr in Prodromal PD patients, and where appropriate the comparison of these rates between patient subsets at study intervals ranging from 12 months to 24 months.
Measured: 24 months
Secondary outcomes (6)
[18F]AV-133 prediction of clinical motor progression
Predictive value of [18F]AV-133 imaging Standardized Uptake Value ratio [SUVr] at baseline for longitudinal clinical progression, defined as change in Movement Disorder Society sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), scale [0-260]
Measured: 24 months
[18F]AV-133 prediction of clinical cognitive progression
Predictive value of [18F]AV-133 imaging Standardized Uptake Value ratio [SUVr] at baseline for longitudinal cognitive progression, defined as change in cognitive scales Montreal Cognitive Assessment (MoCA), scale [0-30]
Measured: 24 months
[18F]AV133 cutoff for clinical PD
Determine [18F]AV-133 SUVr cutoff value for predicting development of clinical diagnosis of PD in people with Prodromal PD.
Compare [18F]AV-133 SUVr with DaTscan SBR cutoffs for predicting the development of clinical diagnosis of PD in people with Prodromal PD.
Measured: 24 months
[18F] AV133 correlation with DaTscan
Correlation between the longitudinal change of [18F]AV-133 and DaTscan.
Measured: 24 months
Correlation of [18F]AV133 change with change in clinical and biomarker outcomes
Correlation between the longitudinal change of imaging outcomes and MDS-UPDRS, other clinical and blood biomarkers and sensor outcomes.
Measured: 24 months
Incidence of Treatment emergent adverse events
Number of participants with treatment-related adverse events
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start30 Oct 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prodromal Parkinsons DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michael J. Fox Foundation for Parkinson's Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ken Marek, MD, Principal investigator, Institute for Neurodegenerative Disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07265596
- Sponsor's protocol ID
- PPMI 015
- Status last verified
- Nov 2025
- First submitted
- 12 Sep 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Longitudinal Imaging in the Parkinson's Progression Markers Initiative Using [18F] AV-133 (PPMI AV-133 Prodromal Imaging)
- ClinicalTrials.gov ID
- NCT07265596
- Acronym / sponsor ID
- PPMI 015
- Conditions
- Prodromal Parkinsons Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Michael J. Fox Foundation for Parkinson's ResearchUniversity, hospital or other
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prodromal Parkinson's disease (PD) | Experimental | Drug: [18F] AV-133 PET ImagingProdromal Parkinson's disease participants enrolled in the PPMI Clinical 002 study will receive 3 injections of [18F] AV-133 and imaging procedures over the course of 24 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- A Prodromal PD participant, over the age of 18, confirmed as eligible to proceed to PPMI Clinical Baseline visit.
- Able to provide informed consent.
- Male or Female (females must meet additional criteria specified below as applicable)
Key exclusion criteria (2 listed)
- 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.
- Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F] AV-133 PET ImagingProdromal PD participants from the PPMI Clinical (002) study will be followed for up to 24 months. These participants will undergo imaging assessments with [18F]AV-133 under this protocol at baseline, 12-month and 24 months. | Drug | Prodromal Parkinson's disease (PD) |
Primary outcome
[18F]AV-133 mean rate of change and variability
Time frame: 24 months
The mean rates of change and the variability around the mean of [18F]AV-133 PET SUVr in Prodromal PD patients, and where appropriate the comparison of these rates between patient subsets at study intervals ranging from 12 months to 24 months.
6 secondary outcomes
[18F]AV-133 prediction of clinical motor progression
Time frame: 24 months
[18F]AV-133 prediction of clinical cognitive progression
Time frame: 24 months
[18F]AV133 cutoff for clinical PD
Time frame: 24 months
[18F] AV133 correlation with DaTscan
Time frame: 24 months
Correlation of [18F]AV133 change with change in clinical and biomarker outcomes
Time frame: 24 months
Incidence of Treatment emergent adverse events
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ken Marek, MD principal investigator
Institute for Neurodegenerative Disorders
8 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing [18F] AV-133 PET Imaging in people with Prodromal Parkinsons Disease, run by Michael J. Fox Foundation for Parkinson's Research at 8 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, United Kingdom, Canada, Germany, Israel and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lianne Ramia (203-590-5600, LRamia1@indd.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
[18F]AV-133 mean rate of change and variability (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.