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

June 5, 2026 updated by: Tammie L. S. Benzinger, MD, PhD, Washington University School of Medicine

Beta Amyloid PET Imaging for Alzheimer Disease: [18F]-Fluselenamyl (Alternative Vehicle) Comparison With [11C]-PIB (FSA-PIB AD)

The purpose of this research study is to determine the safety of a radiotracer 18F-Fluselenamyl using positron emission tomography (PET) imaging.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The investigators will first complete whole-body PET dosimetry studies in healthy adult normal volunteers to calculate the actual radiation dose of each human organ and determine the allowable dose for a human subject when receiving a single dose for a PET scan.

Second, imaging of the brain and neck will be completed in a wide range of ages of healthy adult normal control participants and participants with mild cognitive impairment, both male and females to characterize 18F-Fluselenamyl uptake in the brain, its binding to beta-amyloid plaques, and radiolabeled metabolite will be completed. Amyloid is a protein related to dementia of Alzheimer's disease. 11C-PIB PET imaging and MRI of the brain will also be completed in the same participants and the data will be compared with 18F-Fluselenmayl. 11C-PIB and 18F-Fluselenamyl both bind to beta-amyloid plaques.

Finally, a comparison of the normal control participants to patients with Alzheimer's disease will be completed.

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Aim 1: Dosimetry group - 8 healthy adult normal volunteers (4 M, and 4 F) will undergo whole-body PET/CT imaging to assess the safety, dosimetry, and metabolism of 18F-FSA.

Aim 2: Proof of Concept group - 36 participants (18 healthy and 18 participants with mild cognitive impairment) will undergo 18F-FSA 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-FSA 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 will undergo repeat 18F-FSA, 11C-PIB, MRI, and Cognitive testing.

Description

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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy participants

Healthy participants with normal cognition will be recruited and receive the following interventions:

Drug: [18F]-Fluselenamyl. A dosage range of 10 mCi +/- 20% of Fluselenamyl will be injected by a PET-certified medical professional followed by 10 ml 0.9% sodium chloride (normal saline) flush.

Drug: [11C]-Pittsburgh Compound ([11C]PIB) A dosage range between 6.0-20.0 mCi is planned. A PET-certified professional will prepare and administer the [11C]-PIB tracer. Participants will receive the PIB injection followed by a 10 ml 0.9% sodium chloride (normal saline) flush.
Drug: 18F-Fluselenamyl
Participants will receive a single intravenous bolus injection of 10 mCi ± 20% of the investigational radiotracer 18F-Fluselenamyl and will undergo an 18F-Fluselenamyl PET/CT scan of the head and neck.
Other Names:
  • 18F-FSA
Participants with mild cognitive impairment

Participants with mild cognitive impairment will be recruited and receive the following interventions:

Drug: [18F]-Fluselenamyl. A dosage range of 10 mCi +/- 20% of Fluselenamyl will be injected by a PET-certified medical professional followed by 10 ml 0.9% sodium chloride (normal saline) flush.

Drug: [11C]-Pittsburgh Compound ([11C]PIB) A dosage range between 6.0-20.0 mCi is planned. A PET-certified professional will prepare and administer the [11C]-PIB tracer. Participants will receive the PIB injection followed by a 10 ml 0.9% sodium chloride (normal saline) flush.
Drug: 18F-Fluselenamyl
Participants will receive a single intravenous bolus injection of 10 mCi ± 20% of the investigational radiotracer 18F-Fluselenamyl and will undergo an 18F-Fluselenamyl PET/CT scan of the head and neck.
Other Names:
  • 18F-FSA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the safety of the new formulation of Fluselenamy PET Imaging in 8 healthy adult normal volunteers.
Time Frame: 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).
Through study completion, an average of 1 year
PET imaging of [18F]-Fluselenamyl in healthy normal control participants and participants with mild cognitive impairment.
Time Frame: 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.
Through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Tammie Benzinger, MD., PhD, Washington University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

April 22, 2024

First Submitted That Met QC Criteria

May 29, 2024

First Posted (Actual)

June 3, 2024

Study Record Updates

Last Update Posted (Actual)

June 9, 2026

Last Update Submitted That Met QC Criteria

June 5, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FSA-PIB AD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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