Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06456684
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-03-04
Brief Title:
AV133 Longitudinal Imaging Study in Patients With Early and Prdromal Parkinsons Disease
Sponsor:
Xuanwu Hospital Beijing
Organization:
Xuanwu Hospital Beijing
Study Overview
Official Title:
AV133 Longitudinal Imaging Study in Patients With Early and Prodromal Parkinsons Disease
Status:
RECRUITING
Status Verified Date:
2024-02
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:
A total of 38 patients with early-stage Parkinsons disease and 38 patients with prodromal Parkinsons disease are planned to be enrolled in this study and examined for longitudinal changes in 18FAV-133 through follow-up thereby informing the design of future therapeutic trials utilizing 18FAV-133 as a marker of disease progression
Detailed Description:
This study is a longitudinal study designed to assess the progression of 18FAV-133 imaging in patients with prodromal and early stages of Parkinsons disease Approximately 38 patients with early PD and 38 subjects in the prodromal phase will be enrolled in the study All subjects will undergo imaging assessment with 18FAV-133 at baseline and every 12 months thereafter clinical motor neuropsychiatric and cognitive assessment and biospecimen collection for bioanalysis The study duration for each subject will be approximately 27 months including a 60-day screening period and a 24-month follow-up assessment period Data collection will be performed uniformly for all participants according to the protocol developed
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