Assess Fibrin in Brains With AD/ADRD

NCT ID: NCT05336695

Last Updated: 2025-10-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-29
• Study Completion Date: 2026-09-28

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).

Conditions

Alzheimer Disease; Dementia of Alzheimer Type

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Cognitively Normal Subjects and ADRD subjects

Cognitively Normal Subjects and ADRD subjects

Group Type: EXPERIMENTAL

PET/MR Imaging

Intervention Type: DIAGNOSTIC_TEST

PET/MRI Scan with \[64Cu\]FBP8 as directed by protocol

64Cu-FBP8

Intervention Type: DRUG

Will be administered by intravenous injection by bolus by a qualified nuclear medicine technician at the Martinos Center

Interventions

PET/MR Imaging

PET/MRI Scan with \[64Cu\]FBP8 as directed by protocol

Intervention Type: DIAGNOSTIC_TEST

64Cu-FBP8

Will be administered by intravenous injection by bolus by a qualified nuclear medicine technician at the Martinos Center

Intervention Type: DRUG

Other Intervention Names

Positron Emission Tomography/Magnetic Resonance Imaging; Positron Emission Tomography dye

Eligibility Criteria

Inclusion Criteria

• Age between 55 and 90 years
• Ability to provide informed consent
• Specific to healthy volunteers: no history of ADRD
• Specific to ADRD subjects: clinical diagnosis of AD - either amnestic or atypical, clinical severity ranging from MCI to moderate dementia (CDR 0.5-2.0), MMSE score greater than or equal to 15 and/or MOCA greater than or equal to 12
• Specific to BAnD subjects: referred through the Brain Aging and Dementia (BAnD) research registry

Exclusion Criteria

• MR contraindications such as: electrical implants such as cardiac pacemakers or perfusion pumps; ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants, ferromagnetic objects such as jewelry or metal clips in clothing
• Preexisting medical conditions including a likelihood of developing seizures or claustrophobic reactions, and any greater than normal potential for cardiac arrest
• Subjects whose estimated glomerular filtration rate (eGFR) < 60 mL/min will be excluded from receiving the gadolinium-based contrast agent
• Research-related radiation exposure exceeding current Massachusetts General Hospital (MGH) Radiology Department guidelines (i.e. 50 millisievert in the prior 12 months)
• 3. In line with published MGH IRB guidelines for pregnancy must be ruled out by urine ß-HCG if answers to screening questions suggest that pregnancy is possible and if female participants are premenopausal and of child-bearing age. Subjects will not be able to enroll if they are breastfeeding.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ciprian Catana, MD, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ciprian Catana, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ciprian Catana, MD, PhD

Role: CONTACT

ccatana@mgh.harvard.edu

617-643-4885

Facility Contacts

Ciprian Catana, MD, PhD

Role: primary

ccatana@mgh.harvard.edu

617-643-4885

Other Identifiers

3R01HL109448-07S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2019P002911

Identifier Type: -

Identifier Source: org_study_id