A Phase 2 interventional study of [18F] AV-133 PET Imaging in Prodromal Parkinsons Disease, sponsored by Michael J. Fox Foundation for Parkinson's Research. Recruiting at 8 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-05.
Sponsored by Michael J. Fox Foundation for Parkinson's Research · Phase 2, Interventional, and Diagnostic
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).
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.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's planned enrollment of 100 is above the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Michael J. Fox Foundation for Parkinson's Research is the lead sponsor of 16 studies on the registry; 7 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Male or Female (females must meet additional criteria specified below as applicable)
Females must be of non- or using a highly effective method of 14 days prior to until at least 24 hours after injection of 18F-AV-133
Females of childbearing potential must not be pregnant, breastfeeding or lactating.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: [18F] AV-133 PET Imaging
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.
[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.
Time frame: 24 months
[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 \[0-260\]
Time frame: 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 \[0-30\]
Time frame: 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.
Time frame: 24 months
[18F] AV133 correlation with DaTscan
Correlation between the longitudinal change of \[18F\]AV-133 and DaTscan.
Time frame: 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.
Time frame: 24 months
Incidence of Treatment emergent adverse events
Number of participants with treatment-related adverse events
Time frame: 24 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started Oct 2023 (actual). Primary completion is estimated for Dec 2027, 50 months after the start.
Of 105 non-industry phase 2 interventional studies under Parkinson Disease, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 59. This study's planned 50 months is above that.
Counting every sponsor, half of 201 studies reached it within 28 months; a quarter within 16 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Florbenazine F 18
Michael J. Fox Foundation for Parkinson's Research