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

What this Trial Is About

Researchers are studying fibrin levels in the brains of people ranging from those who are cognitively normal to those clinically diagnosed with Alzheimer's Disease and related dementias (ADRD). Since the cause and progression of ADRD are not fully understood, this study evaluates brain fibrin using a new imaging tool called 64Cu-FBP8-PET, which has not yet been approved by the FDA. The study aims to better understand the role of fibrin in ADRD by comparing affected individuals with healthy controls. Participants will receive an intravenous injection of 64Cu-FBP8, followed by a PET/MRI scan to measure brain fibrin concentration. The study includes both cognitively normal and ADRD subjects, with clinical diagnoses ranging from mild cognitive impairment to moderate dementia. The imaging procedure is performed by qualified medical staff at a specialized center. This project is expected to include about 30 participants and involves no placebo or comparison drugs. During the study, participants will undergo brain imaging to assess fibrin levels, and their cognitive status will be recorded. Researchers will measure fibrin concentration as the main outcome. Safety considerations include screening for MRI contraindications, kidney function, and radiation exposure history. Participants may be followed until study completion in 2026, with all procedures conducted under medical supervision to monitor health and ensure safety.

Assess Fibrin in Brains With AD/ADRD