Assess Fibrin in Brains With AD/ADRD

NCT05336695 | Recruiting Phase 1 FDA Drug FDA Device

• 2 other identifiers: 2019P0029113R01HL109448-07S1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease; Dementia of Alzheimer Type

Keywords

Alzheimer Disease; Dementia

Outcome Measures

Primary Outcomes (1)

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

  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.

  baseline

Study Arms (1)

Cognitively Normal Subjects and ADRD subjects

EXPERIMENTAL

Cognitively Normal Subjects and ADRD subjects

Diagnostic Test: PET/MR Imaging; Drug: 64Cu-FBP8

Interventions

PET/MR Imaging DIAGNOSTIC_TEST

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

Also known as: Positron Emission Tomography/Magnetic Resonance Imaging

Cognitively Normal Subjects and ADRD subjects

64Cu-FBP8 DRUG

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

Also known as: Positron Emission Tomography dye

Cognitively Normal Subjects and ADRD subjects

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• \. 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Interventions

Positron-Emission Tomography; Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Ciprian Catana, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ciprian Catana, MD, PhD

CONTACT

617-643-4885; ccatana@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All subjects will receive the same injection of 64Cu-FBP8 and undergo PET/MR imaging.

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 20, 2022
• Study Start: March 29, 2022
• Primary Completion (Estimated): September 28, 2026
• Study Completion (Estimated): September 28, 2026
• Last Updated: October 30, 2025

Record last verified: 2025-10

Locations

US (1)