Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04507139
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-10-19
First Post:
2020-08-03
Brief Title:
Early Longitudinal Imaging in Parkinsons Progression Markers Initiative Using ¹⁸F AV-133 and DaTscan
Sponsor:
Michael J Fox Foundation for Parkinsons Research
Organization:
Michael J Fox Foundation for Parkinsons Research
Study Overview
Official Title:
Early Longitudinal Imaging in Parkinsons Progression Markers Initiative Using ¹⁸F AV-133 and DaTscan PPMI Early Imaging
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None