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Assessing Fibrin in Brains with Alzheimer's Disease and Related Dementias

This study is looking at how much fibrin (a protein involved in blood clotting) is in the brains of people with Alzheimer's disease and related dementias (ADRD) compared to healthy individuals. Researchers will use a special imaging technique called PET/MR Imaging with a substance called 64Cu-FBP8. This substance is given through an IV and helps them see fibrin in the brain. The goal is to understand if fibrin plays a role in ADRD by measuring its concentration in the brain. About 30 people between 55 and 90 years old can participate. This includes healthy volunteers and those with a clinical diagnosis of AD, ranging from mild cognitive impairment (MCI) to moderate dementia.

Study design
This is an interventional study, meaning participants will receive an intervention (64Cu-FBP8 and PET/MR imaging). Approximately 30 people are planned to enroll.
What's involved
Participants will undergo a PET/MRI scan with 64Cu-FBP8, which will be administered intravenously by a qualified nuclear medicine technician.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, concentration of fibrin, is measured at baseline, meaning at the start of the study.

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NCT05336695

Assess Fibrin in Brains With AD/ADRD

Recruiting
PHASE1Ages 55–90InterventionalDiagnostic
Massachusetts General Hospital
~30 participants
Updated 2025-10-30 on ClinicalTrials.gov
What's tested:PET/MR Imaging64Cu-FBP8

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Concentration of fibrin in the brains of ADRD subjects and healthy controls
Measured over baseline

Conditions

Alzheimer Disease
Dementia of Alzheimer Type

Explore related trials

Alzheimer's DiseaseDementia

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Ciprian Catana, MD, PhD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Ciprian Catana, MD, PhD
[email protected]
617-643-4885
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Concentration of fibrin in the brains of ADRD subjects and healthy controlsbaseline

    64Cu-FBP8-PET will be used to quantify brain fibrin content in the brains of ADRD subjects and healthy controls to evaluate potential regional differences.