Phase 1 Study to Assess Safety and Imaging of 18FACI-15916 PET for Detecting Alpha-Synuclein Deposits in Patients with Suspected Alpha-Synucleinopathies and Healthy Volunteers

What this Trial Is About

Researchers are evaluating a new imaging agent called 18FACI-15916 to safely and reliably measure the buildup of a protein called alpha-synuclein in the brain. This protein is involved in conditions like Parkinsons disease, Lewy body dementia, and Multiple System Atrophy, collectively known as alpha-synucleinopathies. The study includes both healthy volunteers and people with suspected alpha-synuclein-related diseases to compare protein levels and assess safety and detection accuracy. The study is an open-label, early-phase PET microdose trial involving up to 46 participants divided into four parts. Participants will receive an intravenous injection of 18FACI-15916 followed by a PET scan to detect alpha-synuclein deposits. Some will have a second PET scan to test measurement reliability, while others will undergo a whole-body PET-CT scan to estimate radiation dosage. The study includes a screening phase, scanning visits, optional spinal fluid collection, and follow-up safety calls. Participants will visit the clinic for consent, eligibility assessments including physical exams, neurological exams, questionnaires, blood and urine tests, ECG, and in some cases MRI and PET scans with a licensed tracer. During the PET scan, blood samples will be collected, and some may provide spinal fluid. Safety is monitored through follow-up phone calls. The total study duration ranges from 10 to 14 weeks depending on the part of the study the participant is in. Researchers will measure brain uptake of the tracer, adverse events, vital signs, and the reproducibility of PET scan results.

[18F]ACI-15916 PET in α-synucleinopathies