NCT05731440Active, not recruiting
Fluselenamyl - Beta Amyloid PET Imaging for Alzheimer Disease
Source: ClinicalTrials.gov · Last updated 9 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 3 Jan 2023
- Start date
- 18 Nov 2022
- Primary completion date
- Dec 2027
- Lead sponsor
- Washington University School of Medicine
- Diseases
- Alzheimer disease
- NCT number
- NCT05731440
What you commit to
- Study type: Observational
- Planned participants: 60
- From 18 Nov 2022 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Has hypersensitivity to 18F-Fluselenamyl or any of its excipients ;
- Has hypersensitivity to 11C-PIB or any of its excipients ;
- 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);
Other
- 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);
- Women who are currently pregnant or breast-feeding;
Who the study is looking for
- Male or Female, any race
- Age ≥ 18 years
- Healthy volunteers or volunteers with Alzheimer's disease
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.