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NCT07265596 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Prodromal Parkinsons Disease, sponsored by Michael J. Fox Foundation for Parkinson's Research.

Recruiting
Registry status
Phase 2
Development phase
100
Enrollment target
8
Study locations

NCT07265596: Recruiting Phase 2 study of Prodromal Parkinsons Disease, sponsored by Michael J. Fox Foundation for Parkinson's Research.

NCT07265596 is a Phase 2 study of Prodromal Parkinsons Disease that is actively recruiting participants, run by Michael J. Fox Foundation for Parkinson's Research. The registered enrollment target is 100 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07265596, a Phase 2 study of Prodromal Parkinsons Disease, is actively recruiting participants, sponsored by Michael J. Fox Foundation for Parkinson's Research.

RECRUITING
Registry status
Phase 2
Development phase
100 participants
Enrollment target
8
Study locations

Study 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. 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).

Primary Outcome

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.

Interventions

  • DRUG [18F] AV-133 PET Imaging

Study Locations (8)

Other

  • Philipps-University of Marburg - Hessen
  • Tel Aviv Sourasky Medical Center - Tel Aviv

Connecticut

  • Institute for Neurodegenerative Disorders - New Haven

Pennsylvania

  • University of Pennsylvania - Philadelphia

Ontario

  • Toronto Western Hospital - Toronto

Gelderland

  • Radboud University - Nijmegen

Britain

  • Queen Mary University of London - London

Tyne and Wear

  • Newcastle University - Newcastle upon Tyne

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2023-10-30
Est. Completion 2027-12
Phase Phase 2

What NCT07265596 shows while recruiting

NCT07265596 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower).

The record links to 1 condition, with Prodromal Parkinsons Disease appearing as the primary indexed condition, and to 1 intervention - of which [18F] AV-133 PET Imaging is the first listed.

NCT07265596 lists 8 locations in 7 states (Other, Connecticut, Pennsylvania).

Frequently Asked Questions

What is clinical trial NCT07265596 about?

NCT07265596 is a clinical study titled "Early Longitudinal Imaging in the Parkinson's Progressive Marker Initiative (PPMI) 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 assess...

What is the current status of trial NCT07265596?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2023-10-30. Estimated completion is 2027-12.

What conditions does trial NCT07265596 study?

This clinical trial studies the following conditions: Prodromal Parkinsons Disease.

What interventions are being tested in trial NCT07265596?

The interventions under investigation include: [18F] AV-133 PET Imaging (DRUG).

Who is sponsoring clinical trial NCT07265596?

This trial is sponsored by Michael J. Fox Foundation for Parkinson's Research, which has 14 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07265596 being conducted?

This trial has 8 study locations across Connecticut, Pennsylvania, Ontario, Gelderland, Britain. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT07265596's enrollment target sits among peer trials

100 672nd of 2000 higher than 1,263 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07265596, the US trial registry maintained by the National Library of Medicine. NCT07265596 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.