Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06289582
Status:
RECRUITING
Last Update Posted:
2024-03-04
First Post:
2024-02-13
Brief Title:
Longitudinal TSPO PET Imaging with 18FDPA-714 in PPMI PPMI DPA-714 PET Imaging
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Longitudinal TSPO PET Imaging with 18FDPA-714 in PPMI PPMI DPA-714 PET Imaging
Status:
RECRUITING
Status Verified Date:
2024-10
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:
The overall goal of this protocol is to investigate 18FDPA-714 binding in prodromal and early manifest Parkinsons Disease PD and to determine the baseline and change from baseline in 18FDPA-714 binding in PD participants during a 24-month interval
Primary Objectives
To compare 18FDPA-714 binding in prodromal and manifest PD and healthy volunteers
To determine the longitudinal change in 18FDPA-714 during a 24-month interval for prodromal and early initially untreated PD participants
Secondary Objectives
To evaluate the correlation between baseline 18FDPA-714 and PPMI clinical and biomarker outcomes
To evaluate the correlation between the longitudinal change of 18FDPA-714 and PPMI clinical and biomarker outcomes
To acquire safety data following injection of 18FDPA-714
Primary Objectives
To compare 18FDPA-714 binding in prodromal and manifest PD and healthy volunteers
To determine the longitudinal change in 18FDPA-714 during a 24-month interval for prodromal and early initially untreated PD participants
Secondary Objectives
To evaluate the correlation between baseline 18FDPA-714 and PPMI clinical and biomarker outcomes
To evaluate the correlation between the longitudinal change of 18FDPA-714 and PPMI clinical and biomarker outcomes
To acquire safety data following injection of 18FDPA-714
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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