NCT05731440 · ACTIVE NOT RECRUITING
Fluselenamyl - Beta Amyloid PET Imaging for Alzheimer Disease
This trial is testing the safety of a new imaging tracer, 18F-Fluselenamyl, which is designed to light up beta-amyloid plaques on a brain PET scan. Researchers will measure radiation dose and how the tracer behaves in the brain, comparing it to an established tracer. The phase isn't specified. It's an imaging study, not a treatment.
You may qualify if
- Male or Female, any race
- Age ≥ 18 years
- Healthy volunteers or volunteers with Alzheimer's disease
You're excluded if
- Has hypersensitivity to 18F-Fluselenamyl or any of its excipients ;
- Has hypersensitivity to 11C-PIB or any of its excipients ;
- Incapable of providing written informed consent or lacking a legally authorized representative (LAR) to provide informed consent ;
- Unwilling or unable to undergo PET scans tracer injections ;
- Unwilling or unable to undergo MRI (Aim 2 and Aim 3);
- Any condition that, in the Investigator's opinion, could increase risk to the participant, limit the participant's ability to tolerate the research procedures, or interfere with the collection/analysis of the data (e.g., renal or liver failure, advanced cancer);
- Women who are currently pregnant or breast-feeding;
- Current or recent (within 12 months prior to screening) participation in research studies involving radioactive agents such that the total research-related radiation dose to the participant in any given year would exceed the limits set forth in the U.S. Code of Federal Regulations (CFR) Title 21 Section 361.1.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-06-09