Measuring brain fibrin levels in Alzheimer's disease

Assess the Brain Levels of Fibrin in Alzheimer's Disease and Its Related Dementias Subjects Using 64Cu-FBP8 PET

This study is testing a new imaging technique to see how levels of a protein called fibrin in the brain differ among people with Alzheimer's disease and those with normal thinking skills.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 55 Years to 90 Years
• Sex: All
• Sponsor: Massachusetts General Hospital (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT05336695 on ClinicalTrials.gov

What this trial studies

This project aims to quantify brain fibrin content using 64Cu-FBP8-PET imaging in individuals with varying cognitive statuses, from healthy to those diagnosed with Alzheimer's disease and related dementias (ADRD). The study will explore regional differences in fibrin levels, which may play a role in the pathophysiology of ADRD. Approximately 30 participants will be involved, and the study will utilize a novel imaging technique that is not yet FDA-approved. The findings could enhance our understanding of the relationship between fibrin and ADRD.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 55 to 90, both cognitively normal and those clinically diagnosed with Alzheimer's disease or related dementias.

Not a fit: Patients with contraindications for MR imaging or those with preexisting medical conditions that may complicate participation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the role of fibrin in Alzheimer's disease, potentially leading to new therapeutic targets.

How similar studies have performed: While the approach of quantifying brain fibrin in vivo is novel, related studies have shown promise in understanding the role of fibrin in other conditions.

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.

Where this trial is running

Boston, Massachusetts

• Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: Ciprian Catana, MD, PhD — Massachusetts General Hospital
• Study coordinator: Ciprian Catana, MD, PhD

Conditions Alzheimer Disease; Dementia of Alzheimer Type; Dementia