Using a new imaging agent to study Alzheimer's disease
Beta Amyloid PET Imaging for Alzheimer Disease: [18F]-Fluselenamyl (Alternative Vehicle) Comparison With [11C]-PIB (FSA-PIB AD)
Washington University School of Medicine · NCT06439992
This study is testing a new imaging agent to see how well it can help visualize Alzheimer's disease and its effects on the brain in both healthy people and those with mild cognitive impairment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT06439992 on ClinicalTrials.gov |
What this trial studies
This research aims to assess the safety of the radiotracer 18F-Fluselenamyl through positron emission tomography (PET) imaging. Initially, whole-body PET dosimetry studies will be conducted in healthy volunteers to determine the radiation dose for human subjects. Following this, brain and neck imaging will be performed on both healthy participants and those with mild cognitive impairment to evaluate the uptake of 18F-Fluselenamyl and its binding to beta-amyloid plaques. The study will also compare the imaging results between normal controls and Alzheimer's disease patients.
Who should consider this trial
Good fit: Ideal candidates include healthy adults and individuals diagnosed with Alzheimer's disease aged 18 and older.
Not a fit: Patients with hypersensitivity to the imaging agents or those unable to undergo PET scans or MRIs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of Alzheimer's disease and improve diagnostic imaging techniques.
How similar studies have performed: Previous studies using similar PET imaging approaches have shown promise in characterizing amyloid plaque deposition in Alzheimer's disease.
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 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.
Where this trial is running
St Louis, Missouri
- Washington University School of Medicine — St Louis, Missouri, United States (RECRUITING)
Study contacts
- Principal investigator: Tammie Benzinger, MD., PhD — Washington University School of Medicine
- 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.
Conditions: Alzheimer Disease