Recruiting
Phase 1
Phase 2

Fibrin in AD

Sponsor:

Massachusetts General Hospital

Code:

NCT05336695

Conditions

Alzheimer Disease

Dementia of Alzheimer Type

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Accepted

Interventions

PET/MR Imaging

64Cu-FBP8

Study Details

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

Study ID

NCT05336695

Start date

Mar 29, 2022

Status verified date

Oct, 2025

Completion date

Sep 28, 2026

Anticipated

Primary completion date

Sep 28, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Cognitively Normal Subjects and ADRD subjects

Cognitively Normal Subjects and ADRD subjects

Interventions

PET/MR Imaging

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

64Cu-FBP8

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

Primary outcome measure

  • Concentration of fibrin in the brains of ADRD subjects and healthy controls [ Time Frame: baseline ]

Central Contacts and Locations

Central contacts

Ciprian Catana, MD, PhD

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

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Ciprian Catana, MD, PhD

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

Principal Investigator:

Ciprian Catana, MD, PhD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Oct 30, 2025

Last verified

Oct, 2025

Keywords

  • Alzheimer Disease
  • Dementia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-10-30.