Beta Amyloid PET Imaging for Alzheimer Disease With [18F]-Fluselenamyl

This research study is looking at the safety of a new formulation of a radiotracer called 18F-Fluselenamyl. This tracer is used with a PET (positron emission tomography) scan, which is a type of imaging, to look for beta-amyloid plaques in the brain. Beta-amyloid is a protein linked to Alzheimer's disease. The study will first check the radiation dose of 18F-Fluselenamyl in healthy volunteers. Then, it will use PET scans to see how 18F-Fluselenamyl binds to beta-amyloid plaques in healthy adults and people with mild cognitive impairment. This will be compared to another tracer, 11C-PIB, and MRI scans. Finally, the study will compare results between healthy individuals and those with Alzheimer's disease. You may be able to join if you are at least 18 years old and are a healthy volunteer or have Alzheimer's disease. The study aims to understand the safety of 18F-Fluselenamyl and how it works in the brain.

Study design: This is an observational study with a planned enrollment of 60 participants. It is not specified if it is randomized, blinded, or what phase it is in.
What's involved: Participants will receive a single intravenous injection of 18F-Fluselenamyl and undergo an 18F-Fluselenamyl PET/CT scan. Some participants will also have 11C-PIB PET imaging and an MRI of the brain.
Compensation: Not stated in the trial record.
Follow-up: Safety will be evaluated through study completion, which is an average of 1 year. PET imaging will be evaluated through study completion, an average of 2 years.

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Beta Amyloid PET Imaging for Alzheimer Disease With [18F]-Fluselenamyl

Recruiting

Not specifiedAges 18+Observational

Washington University School of Medicine

~60 participants

Updated 2026-06-09 on ClinicalTrials.gov

What's tested:18F-Fluselenamyl

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

To evaluate the safety of the new formulation of Fluselenamy PET Imaging in 8 healthy adult normal volunteers.

Measured over Through study completion, an average of 1 year

+1 more outcome measured

Conditions

Alzheimer Disease

Where it's being run

1 sites across 1 states

Missouri1

Study leadership

Tammie Benzinger, MD., PhD · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

Who to contact

Jayashree Rajamanickam

[email protected]

314 273 6140

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Male or Female, any race

Age ≥ 18 years

Healthy volunteers or volunteers with Alzheimer's disease

Exclusion

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 the 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.

What this trial measures

To evaluate the safety of the new formulation of Fluselenamy PET Imaging in 8 healthy adult normal volunteers.Through study completion, an average of 1 year
Whole-body PET/CT images (skull vertex to proximal thighs) will be obtained in 8 healthy volunteers (4 males and 4 females) for up to a maximum of 4.5 hours immediately following intravenous (IV) injection of 10 mCi ± 20% of \[18F\]-Fluselenamyl (dosage range calculated from rodent dosimetry data extrapolated to humans). The primary outcome measure is to quantify each organ's radiation exposure (rad/mCi).
PET imaging of [18F]-Fluselenamyl in healthy normal control participants and participants with mild cognitive impairment.Through study completion, an average of 2 years
To assess the sensitivity of \[18F\]-Fluselenamyl to image Amyloid beta in the setting of mild cognitive impairment, and conduct a comparative analysis of PET imaging data using \[11C\]-PIB imaging in the same participants.

Trialytics