Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2025-12-27 @ 9:28 PM
Study NCT ID:
NCT05336695
Status:
RECRUITING
Last Update Posted:
2025-10-30
First Post:
2022-04-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assess Fibrin in Brains With AD/ADRD
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
Assess the Brain Levels of Fibrin in Alzheimer's Disease and Its Related Dementias Subjects Using 64Cu-FBP8 PET
Status:
RECRUITING
Status Verified Date:
2025-10
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 goal of this project is to quantify brain fibrin content using 64Cu-FBP8-PET in the brains of subjects ranging from cognitively normal to clinically diagnosed with ADRD to evaluate potential regional differences.
Detailed Description:
While there are many potential therapeutics being evaluated for Alzheimer's disease and related dementias (ADRD), there is currently no known cure for ADRD and its origin and pathophysiology are still not well understood. However, the association of fibrin with ADRD is becoming increasingly clearer. Up to now it was not possible to quantify brain fibrin in vivo to better elucidate its role in ADRD, but recently, 64Cu-FBP8 was proposed as a tool to detect thrombus anywhere in the body. This unique tool will allow us to non-invasively assess brain fibrin levels in at-risk and ADRD subjects.
The goal of this project is to use 64Cu-FBP8-PET in the brains of subjects ranging from cognitively normal to clinically diagnosed with ADRD to assess fibrin levels. It is expected that about 30 people will take part in this research study. 64Cu-FBP8-PET is not currently approved by the U.S. Food and Drug Administration (FDA).
The goal of this project is to use 64Cu-FBP8-PET in the brains of subjects ranging from cognitively normal to clinically diagnosed with ADRD to assess fibrin levels. It is expected that about 30 people will take part in this research study. 64Cu-FBP8-PET is not currently approved by the U.S. Food and Drug Administration (FDA).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 3R01HL109448-07S1 | NIH | None | https://reporter.nih.gov/quic… | View |