Trials / Active Not Recruiting
Active Not RecruitingNCT04507139
Early Longitudinal Imaging in Parkinson's Progression Markers Initiative Using [¹⁸F] AV-133 and DaTscan™
Early Longitudinal Imaging in Parkinson's Progression Markers Initiative Using [¹⁸F] AV-133 and DaTscan™ (PPMI Early Imaging)
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 50 (estimated)
- Sponsor
- Michael J. Fox Foundation for Parkinson's Research · Academic / Other
- Sex
- All
- Age
- 30 Years
- Healthy volunteers
- Not accepted
Summary
Directly examine whether early (6-month) imaging with DaTscan and \[¹⁸F\] AV-133 will provide an early signal of disease progression in recently diagnosed untreated PD patients.
Detailed description
The study is a longitudinal, multi-center study to assess progression of DaTscan and \[18F\] AV-133 imaging in PD and Prodromal patients. Participants will be followed for up to 24 months. Approximately 50 early PD participants and 100 Prodromal participants will be recruited from up to 15 sites. Participants will be comprehensively assessed at baseline and follow up according to the Schedule of Activities for the respective cohort. Participants will undergo imaging assessments with DaTscan and \[18F\] AV-133 and clinical (motor, neuropsychiatric and cognitive) assessments. Data will be collected by each site under uniformly established protocols and data will be stored and analyzed at designated core facilities.
Conditions
Timeline
- Start date
- 2020-09-10
- Primary completion
- 2025-06-01
- Completion
- 2025-06-01
- First posted
- 2020-08-11
- Last updated
- 2024-10-31
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT04507139. Inclusion in this directory is not an endorsement.