Assess Fibrin in Brains With AD/ADRD
Massachusetts General Hospital · with National Heart, Lung, and Blood Institute (NHLBI) · NCT05336695
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 55–90 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Phase 1, Phase 2
- Target enrollment
- 30
- US sites recruiting
- 1
- Study start
- March 29, 2022
- Record last updated
- October 30, 2025
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: PET/MR Imaging; 64Cu-FBP8
Conditions: Alzheimer Disease; Dementia of Alzheimer Type
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
Recruiting US locations
Massachusetts General Hospital
Boston, MA 02115
Site contact: Ciprian Catana, MD, PhD · 617-643-4885 · ccatana@mgh.harvard.edu
Study contacts (from the official record)
- Ciprian Catana, MD, PhD · 617-643-4885 · ccatana@mgh.harvard.edu
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