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

  • STATUS
    Recruiting
  • End date
    Nov 24, 2025
  • participants needed
    60
  • sponsor
    Washington University School of Medicine
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Updated on 24 January 2025
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Accepts healthy volunteers

Summary

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

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.

Details
Condition Alzheimer Disease
Age 18years or above
Clinical Study IdentifierNCT06439992
SponsorWashington University School of Medicine
Last Modified on24 January 2025

Eligibility

 Yes No Not Sure

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
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