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New PET tracer aims to spot Alzheimer's plaques safely

NCT ID NCT05731440

Diagnosis Sponsor: Washington University School of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new radioactive tracer called Fluselenamyl for PET scans to detect beta-amyloid plaques in the brain, a hallmark of Alzheimer's disease. Researchers will check its safety and how well it works in 60 healthy volunteers and people with mild cognitive impairment or Alzheimer's. The goal is to improve diagnosis by comparing this new tracer with an existing one.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
18F-Fluselenamyl (a radioactive tracer for PET scans)
What this could lead to
If successful, this could provide a safer and more accessible way to detect Alzheimer's-related brain changes early, aiding diagnosis and research.
What could go wrong
This is an early-phase safety and imaging study with only 60 participants. The tracer may not prove more effective than existing methods, and results may not apply to all populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2022

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Aim 1: Dosimetry - 8 healthy adult normal volunteers (4 Males, 4 Females) will undergo whole-body PET/CT imaging for assessing the safety, dosimetry, and metabolism of 18F-Fluselenamyl. Aim 2: Proof of Concept- 36 participants (18 healthy and 18 participants with mild cognitive decline)will undergo 18F-Fluselenamyl imaging of the brain and neck, 11C-PIB imaging of the brain and neck, MRI, and Cognitive testing. Aim 3: Performance group- Aim 2 participants will be invited for additional imaging. Aim 3A- 10 participants from Aim 2 will undergo repeat 18F-Fluselenamyl imaging \~ 1 month after baseline imaging Aim 3B- 18 participants from Aim 2 will have a longitudinal follow-up visit \~ 18 months after the initial study. They undergo repeat 18F-Fluselenamyl, 11C-PIB, MRI, and Cognitive testing.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or Female, any race * Age ≥ 18 years * Healthy volunteers or volunteers with Alzheimer's disease Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alzheimer disease

Contacts and locations

Locations

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.