Fluselenamyl - Beta Amyloid PET Imaging for Alzheimer Disease

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

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 along with MRI 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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

18F-Fluselenamyl

Drug

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.

Primary outcomes

To determine the safety of the tracer [18F]-Fluselenamyl for PET Imaging.

Time frame: 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 objective is to evaluate the biodistribution, kinetics and calculate human dosimetry of this radioligand and confirm it's lack of toxicity in human subjects.
PET imaging of [18F]-Fluselenamyl in healthy normal control participants and human participants with mild cognitive impairment of Alzheimer's dementia.

Time frame: 2 years

To assess the sensitivity of [18F]-Fluselenamyl to image Amyloid beta in the setting of mild cognitive impairment, and conduct comparative analysis of PET imaging data using [11C]-PIB imaging in same participants.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2027
Study completion: 2027
First posted: Feb 16, 2023
Registry last updated: Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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