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Beta Amyloid PET Imaging for Alzheimer Disease With [18F]-Fluselenamyl | Clinical Trials | Clareo Health

RECRUITING

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

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

NCT06439992•Washington University School of Medicine

View on ClinicalTrials.gov

Summary

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

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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.

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States

Key Dates

Start Date

November 7, 2023

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2026

Last Updated

June 10, 2025

Enrollment

ESTIMATED participants

Conditions

Alzheimer Disease

Interventions

18F-Fluselenamyl

DRUG

Contacts

Jayashree Rajamanickam

CONTACT

314 273 6140 jayashree.r@wustl.edu

Kelley Jackson

CONTACT

kelleyj@wustl.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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