Prodromal Parkinson's DiseasePhase 2NCT07809438
A Comparative Performance Study Between High and Standard Resolution Positron Emission Tomography Camera Using [18F] AV-133 in Prodromal Parkinson's Disease
A Phase 2 study testing [18F] AV-133 PET Imaging in people with Prodromal Parkinson's Disease, run by Michael J. Fox Foundation for Parkinson's Research at 1 site in United States.
Trial summary
This study is a single-center, longitudinal study and will be conducted at the Institute for Neurodegenerative (INDD) Site in New Haven, CT. This study aims to recruit participants from the ongoing Parkinson's Progression Markers Initiative AV-133 Prodromal Imaging sub study [PPMI 015] to obtain a second comparison… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prodromal Parkinson's Disease
- What is being tested?
- [18F] AV-133 PET Imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2025to 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
- Prodromal participant enrolled in the PPMI 015 sub study.
- Able to provide consent.
Who cannot join
- Any medical or psychiatric condition or lab abnormality that precludes participation per investigators judgement.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Institute for Neurodegenerative Disorders
New Haven, Connecticut, 06510
Mackenzee George Clinical Research Coordinator II, 475-318-8248, mgeorge@xingimaging.com
Kristen Hagwell Clinical Research Nurse II, RN, 475-318-8259, khagwell@xingimaging.com
About this study
Official title: A Comparative Performance Study Between High and Standard Resolution Positron Emission Tomography (PET) Camera Using [18F]AV-133 in Prodromal Parkinson's Disease [Dual PET AV133 in Prodromal PD]
This study is a single-center, longitudinal study and will be conducted at the Institute for Neurodegenerative (INDD) Site in New Haven, CT. This study aims to recruit participants from the ongoing Parkinson's Progression Markers Initiative AV-133 Prodromal Imaging sub study [PPMI 015] to obtain a second comparison imaging scan. In addition to being imaged with the standard Positron Emission Tomography (PET) camera after the [18F]AV133 injection in the PPMI 015 sub study, participants agreeing to a second scan will be imaged with the NeuroEXPLORER (NX) PET camera per this protocol.
This study will enroll approximately 25 participants at the INDD site. The dual PET scans will be completed at baseline, 1-and 2- years follow up. Participants may be asked to undergo further longitudinal scans based on the acquired study data.
All participants will have longitudinal clinical, biomarker, and genetic data for correlation analyses to imaging data from the PPMI Clinical study.
- Conditions
- Prodromal Parkinson's 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
The study will compare the performance of [18F]AV133 on both NX and standard PET camera in study participants enrolled at the INDD site in PPMI 015.
| Study group | Role | What they receive |
|---|---|---|
| Prodromal Parkinson's disease (PD) | Experimental | Not described Receives: Drug: [18F] AV-133 PET Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of tracer uptake between two camera using Standardized Uptake Value ratio
To compare [18F]AV133 Standardized Uptake Value Ratio (SUVR) in striatal regions and additional relevant regions for images acquired with NX compared to Siemens Biograph in all participants
Measured: Up to 24 months
Secondary outcomes (4)
Longitudinal comparison of quantitative signals (SUVR) between two PET cameras
To compare the longitudinal regional change in [18F]AV133 SUVR in images acquired with NX PET and Siemens Biograph PET
Measured: 24 months
Correlation of AV133 longitudinal change to clinical motor change
Correlation between longitudinal change in [18F]AV133 with NX derived SUVR in different brain regions and change in MDS-UPDRS score reported as correlation coefficient.
Measured: 24 months
Correlation of AV133 longitudinal change to clinical cognitive change
Correlation between longitudinal change in [18F]AV133 with NX derived SUVR in different brain regions and change in Montreal Cognitive Assessment (MoCA) score reported as correlation coefficient.
Measured: 24 months
Correlation of AV133 Longitudinal change to CSF biomarker
Correlation between longitudinal change in [18F]AV133 with NX derived SUVR in different brain regions and change in cerebrospinal fluid (CSF)- seed amplification assay (SAA) level reported as correlation coefficient.
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 posted9 Sep 2026
- Study start18 Sep 2025
- 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 Parkinson's 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
- 25 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
- NCT07809438
- Sponsor's protocol ID
- PPMI 030
- Status last verified
- Sep 2026
- First submitted
- 17 Oct 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data obtained during the conduct of this study will be sent to the Laboratory of Neuro Imaging (LONI) in Los Angeles, California to be stored indefinitely for research purposes. Research data will be made available to researchers to conduct analyses related to PD and other disorders. Researchers will be required to comply with the PPMI data agreement to receive data. All personally identifiable information will be removed before it is shared outside the study
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Performance Study Between High and Standard Resolution Positron Emission Tomography (PET) Camera Using [18F]AV-133 in Prodromal Parkinson's Disease [Dual PET AV133 in Prodromal PD]
- ClinicalTrials.gov ID
- NCT07809438
- Acronym / sponsor ID
- PPMI 030
- Conditions
- Prodromal Parkinson's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Michael J. Fox Foundation for Parkinson's ResearchUniversity, hospital or other
- Study start
- 18 Sep 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 9 Sep 2026 (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.
This study is a single-center, longitudinal study and will be conducted at the Institute for Neurodegenerative (INDD) Site in New Haven, CT. This study aims to recruit participants from the ongoing Parkinson's Progression Markers Initiative AV-133 Prodromal Imaging sub study [PPMI 015] to obtain a second comparison imaging scan. In addition to being imaged with the standard Positron Emission Tomography (PET) camera after the [18F]AV133 injection in the PPMI 015 sub study, participants agreeing to a second scan will be imaged with the NeuroEXPLORER (NX) PET camera per this protocol.
This study will enroll approximately 25 participants at the INDD site. The dual PET scans will be completed at baseline, 1-and 2- years follow up. Participants may be asked to undergo further longitudinal scans based on the acquired study data.
All participants will have longitudinal clinical, biomarker, and genetic data for correlation analyses to imaging data from the PPMI Clinical study.
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 Imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Prodromal participant enrolled in the PPMI 015 sub study.
- Able to provide consent.
Key exclusion criteria (1 listed)
- Any medical or psychiatric condition or lab abnormality that precludes participation per investigators judgement.
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 ImagingThe study will compare the performance of [18F]AV133 on both NX and standard PET camera in study participants enrolled at the INDD site in PPMI 015. | Drug | Prodromal Parkinson's disease (PD) |
Primary outcome
Comparison of tracer uptake between two camera using Standardized Uptake Value ratio
Time frame: Up to 24 months
To compare [18F]AV133 Standardized Uptake Value Ratio (SUVR) in striatal regions and additional relevant regions for images acquired with NX compared to Siemens Biograph in all participants
4 secondary outcomes
Longitudinal comparison of quantitative signals (SUVR) between two PET cameras
Time frame: 24 months
Correlation of AV133 longitudinal change to clinical motor change
Time frame: 24 months
Correlation of AV133 longitudinal change to clinical cognitive change
Time frame: 24 months
Correlation of AV133 Longitudinal change to CSF biomarker
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 9 Sep 2026.
- Individual participant dataSharing planned: Yes. All data obtained during the conduct of this study will be sent to the Laboratory of Neuro Imaging (LONI) in Los Angeles, California to be stored indefinitely for research purposes. Research data will be made available to researchers to conduct analyses related to PD and other disorders. Researchers will be required to comply with the PPMI data agreement to receive data. All personally identifiable information will be removed before it is shared outside the study
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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
1 site in 1 country: 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 Parkinson's Disease, run by Michael J. Fox Foundation for Parkinson's Research at 1 site in United States.
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 2 inclusion and 1 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 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Comparison of tracer uptake between two camera using Standardized Uptake Value ratio (time frame: Up to 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 9 Sep 2026.