Recruiting

[18F]-Fluselenamyl

Sponsor:

Washington University School of Medicine

Code:

NCT06439992

Conditions

Alzheimer Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

18F-Fluselenamyl

Study Details

Brief summary:

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

Conditions

Alzheimer Disease

Study ID

NCT06439992

Start date

Nov 7, 2023

Status verified date

Jun, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Jayashree Rajamanickam

314 273 6140jayashree.r@wustl.edu

Kelley Jackson

kelleyj@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Jayashree Rajamanickam

314 273 6140jayashree.r@wustl.edu

Kelley Jackson

314 362 3613kelleyj@wustl.edu

More Information

Sponsor

Washington University School of Medicine

Last update posted

Jun 9, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-06-09.