Fluselenamyl - Beta Amyloid PET Imaging for Alzheimer Disease (NCT05731440) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Fluselenamyl - Beta Amyloid PET Imaging for Alzheimer Disease
United States60 participantsStarted 2022-11-18
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is testing a brand-new PET imaging tracer called fluselenamyl rather than a treatment, can you help me understand whether participating would give me any direct benefit, or is it mainly contributing to research on detecting Alzheimer's-related amyloid in the brain?
2The trial is no longer actively enrolling new participants — does that mean the window to join has closed, and if so, are there similar amyloid PET imaging studies I might still be eligible for?
3Because this is listed as 'Phase NA,' meaning it's an early-stage imaging study still establishing basic safety of the tracer, what do we know so far about any risks or side effects from receiving this radioactive compound?
4This study is enrolling both healthy people and those with mild cognitive impairment or early Alzheimer's dementia — given my specific diagnosis, which group would I fall into, and does that change what the study experience would look like for me?
5If fluselenamyl PET imaging shows amyloid buildup in my brain, would that result be shared with me and my care team, and could it actually change the treatment plan you'd recommend for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To determine the safety of the tracer [18F]-Fluselenamyl for PET Imaging.
Timeframe: 1 year
2
PET imaging of [18F]-Fluselenamyl in healthy normal control participants and human participants with mild cognitive impairment of Alzheimer's dementia.