Alzheimer DiseaseNCT05731440
Fluselenamyl - Beta Amyloid PET Imaging for Alzheimer Disease
An observational study of Alzheimer Disease, run by Washington University School of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- 18F-Fluselenamyl
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2022to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Aim 1: Dosimetry - 8 healthy adult normal volunteers (4 Males, 4 Females) will undergo whole-body PET/CT imaging for assessing the safety, dosimetry, and metabolism of 18F-Fluselenamyl. Aim 2: Proof of Concept- 36 participants (18 healthy and 18 participants with mild cognitive decline)will undergo 18F-Fluselenamyl imaging of the brain and neck, 11C-PIB imaging of the brain and neck, MRI, and Cognitive testing. Aim 3: Performance group- Aim 2 participants will be invited for additional imaging. Aim 3A- 10 participants from Aim 2 will undergo repeat 18F-Fluselenamyl imaging ~ 1 month after baseline imaging Aim 3B- 18 participants from Aim 2 will have a longitudinal follow-up visit ~ 18 months after the initial study. They undergo repeat 18F-Fluselenamyl, 11C-PIB, MRI, and Cognitive testing.
Who may be able to join
- Male or Female, any race
- Age ≥ 18 years
- Healthy volunteers or volunteers with Alzheimer's disease
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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.
Read more
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.
- Conditions
- Alzheimer Disease
- Being tested
- 18F-Fluselenamyl
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FluselenamylDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy participants | 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 10 ml 0.9% sodium chloride (normal saline) flush. Receives: Drug: 18F-Fluselenamyl | |
| Participants with mild cognitive impairment | 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 10 ml 0.9% sodium chloride (normal saline) flush. Receives: Drug: 18F-Fluselenamyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety of the tracer [18F]-Fluselenamyl for PET Imaging.
Whole-body PET/CT images (skull vertex to proximal thighs) will be obtained in 8 healthy volunteers (4 males and 4 females) for up to a maximum of 4.5 hours immediately following intravenous (IV) injection of 10 mCi ± 20% of [18F]-Fluselenamyl (dosage range calculated from rodent dosimetry data extrapolated to humans).
The primary objective is to evaluate the biodistribution, kinetics and calculate human dosimetry of this radioligand and confirm it's lack of toxicity in human subjects.
Measured: 1 year
PET imaging of [18F]-Fluselenamyl in healthy normal control participants and human participants with mild cognitive impairment of Alzheimer's dementia.
To assess the sensitivity of [18F]-Fluselenamyl to image Amyloid beta in the setting of mild cognitive impairment, and conduct comparative analysis of PET imaging data using [11C]-PIB imaging in same participants.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start18 Nov 2022
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tammie L. S. Benzinger, MD, PhD, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05731440
- Sponsor's protocol ID
- Fluselenamyl (FSA)
- Status last verified
- Jun 2026
- First submitted
- 3 Jan 2023
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluselenamyl - Beta Amyloid PET Imaging for Alzheimer Disease
- ClinicalTrials.gov ID
- NCT05731440
- Acronym / sponsor ID
- Fluselenamyl (FSA)
- Conditions
- Alzheimer Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 18 Nov 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 16 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy participants | – | Drug: 18F-FluselenamylDrug: [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 10 ml 0.9% sodium chloride (normal saline) flush. |
| Participants with mild cognitive impairment | – | Drug: 18F-FluselenamylDrug: [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 10 ml 0.9% sodium chloride (normal saline) flush. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Aim 1: Dosimetry - 8 healthy adult normal volunteers (4 Males, 4 Females) will undergo whole-body PET/CT imaging for assessing the safety, dosimetry, and metabolism of 18F-Fluselenamyl. Aim 2: Proof of Concept- 36 participants (18 healthy and 18 participants with mild cognitive decline)will undergo 18F-Fluselenamyl imaging of the brain and neck, 11C-PIB imaging of the brain and neck, MRI, and Cognitive testing. Aim 3: Performance group- Aim 2 participants will be invited for additional imaging. Aim 3A- 10 participants from Aim 2 will undergo repeat 18F-Fluselenamyl imaging ~ 1 month after baseline imaging Aim 3B- 18 participants from Aim 2 will have a longitudinal follow-up visit ~ 18 months after the initial study. They undergo repeat 18F-Fluselenamyl, 11C-PIB, MRI, and Cognitive testing.
Key inclusion criteria (3 listed)
- Male or Female, any race
- Age ≥ 18 years
- Healthy volunteers or volunteers with Alzheimer's disease
Key exclusion criteria (8 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-FluselenamylParticipants 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. | Drug | Healthy participants, Participants with mild cognitive impairment |
Primary outcome
To determine the safety of the tracer [18F]-Fluselenamyl for PET Imaging.
Time frame: 1 year
Whole-body PET/CT images (skull vertex to proximal thighs) will be obtained in 8 healthy volunteers (4 males and 4 females) for up to a maximum of 4.5 hours immediately following intravenous (IV) injection of 10 mCi ± 20% of [18F]-Fluselenamyl (dosage range calculated from rodent dosimetry data extrapolated to humans). The primary objective is to evaluate the biodistribution, kinetics and calculate human dosimetry of this radioligand and confirm it's lack of toxicity in human subjects.
PET imaging of [18F]-Fluselenamyl in healthy normal control participants and human participants with mild cognitive impairment of Alzheimer's dementia.
Time frame: 2 years
To assess the sensitivity of [18F]-Fluselenamyl to image Amyloid beta in the setting of mild cognitive impairment, and conduct comparative analysis of PET imaging data using [11C]-PIB imaging in same participants.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the safety of the tracer [18F]-Fluselenamyl for PET Imaging. (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.