Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06439992

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

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

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 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.

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 of the head and neck.

Other names: 18F-FSA

Primary outcomes

  1. 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).

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jayashree Rajamanickam

CONTACT

[email protected]

314 273 6140

Kelley Jackson

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 3, 2024
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.

Published trials that share one or more normalized conditions with this study.