Early Phase 1 Study of 18FACI-19626 PET Imaging to Detect TDP-43 Protein Deposits in the Brain Comparing Patients with Suspected TDP-43 Proteinopathies and Healthy Adults Aged 40 to 70

What this Trial Is About

Researchers are evaluating a new imaging method to detect the accumulation of a protein called TDP-43, which is linked to rare brain diseases like frontotemporal dementia FTD and amyotrophic lateral sclerosis ALS. The study aims to see if the new PET tracer, called 18FACI-19626, is safe when injected and if it can reliably show abnormal TDP-43 in the brain. The study includes both healthy people and those suspected of having TDP-43 protein buildup to compare differences. The study involves up to 45 participants split into groups healthy controls, symptomatic gene mutation carriers with FTD, and patients with other TDP-43 related diseases. Participants receive an intravenous injection of 18FACI-19626 followed by a PET scan to track the tracers brain uptake. Some participants may have a second PET scan within a month to check if the results are consistent. The study lasts up to 3 months, including screening, scanning, and follow-up. During the study, participants will undergo physical and neurological exams, questionnaires, blood and urine tests, ECGs, and sometimes MRI scans to confirm eligibility and health status. After the PET scan, blood samples are taken, and participants receive a phone call 2 to 4 days later to monitor any side effects. The main measurements include safety assessments, brain uptake of the tracer, and how well the scans can quantify TDP-43. The study also evaluates radiation exposure and tracer consistency between scans.

[18F]ACI-19626 PET in TDP-43 Proteinopathies