Using a new imaging agent to study Alzheimer's disease
Fluselenamyl - Beta Amyloid PET Imaging for Alzheimer Disease
This study is testing a new imaging agent to see how well it can help us understand Alzheimer's disease by comparing it with current imaging methods in both healthy people and those with mild cognitive issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Saint Louis, Missouri) |
| Trial ID | NCT05731440 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the safety of the radiotracer 18F-Fluselenamyl through positron emission tomography (PET) imaging. Initially, whole-body PET dosimetry studies will be conducted in healthy adult volunteers to assess radiation exposure. Following this, brain and neck imaging will be performed on both healthy participants and those with mild cognitive impairment to analyze the uptake of 18F-Fluselenamyl in relation to beta-amyloid plaques, comparing it with existing imaging agents like 11C-PIB. The study will help characterize the binding properties of the new agent in the context of Alzheimer's disease.
Who should consider this trial
Good fit: Ideal candidates include healthy adults and individuals with Alzheimer's disease aged 18 and older.
Not a fit: Patients with hypersensitivity to the imaging agents or those unable to undergo PET or MRI scans may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding and diagnosis of Alzheimer's disease through improved imaging techniques.
How similar studies have performed: Other studies using similar PET imaging approaches have shown promise, but the specific use of 18F-Fluselenamyl is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Saint Louis, Missouri
- Washington University School of Medicine — Saint Louis, Missouri, United States (Recruiting)
Study contacts
- Study coordinator: Jayashree Rajamanickam
- Email: jayashree.r@wustl.edu
- Phone: 314 273 6140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.