Beta Amyloid PET Imaging for Alzheimer Disease With [18F]-Fluselenamyl

NCT06439992 | Recruiting DMC FDA Drug

• 1 other identifier: FSA-PIB AD
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to determine the safety of a radiotracer 18F-Fluselenamyl using positron emission tomography (PET) imaging.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (2)

• To evaluate the safety of the new formulation of Fluselenamy PET Imaging in 8 healthy adult normal volunteers.

  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 outcome measure is to quantify each organ's radiation exposure (rad/mCi).

  Through study completion, an average of 1 year

• PET imaging of [18F]-Fluselenamyl in healthy normal control participants and participants with mild cognitive impairment.

  To assess the sensitivity of \[18F\]-Fluselenamyl to image Amyloid beta in the setting of mild cognitive impairment, and conduct a comparative analysis of PET imaging data using \[11C\]-PIB imaging in the same participants.

  Through study completion, an average of 2 years

Study Arms (2)

Healthy participants

Healthy participants with normal cognition will be recruited and receive the following interventions: 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 a 10 ml 0.9% sodium chloride (normal saline) flush.

Drug: 18F-Fluselenamyl

Participants with mild cognitive impairment

Participants with mild cognitive impairment will be recruited and receive the following interventions: 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 a 10 ml 0.9% sodium chloride (normal saline) flush.

Drug: 18F-Fluselenamyl

Interventions

18F-Fluselenamyl DRUG

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 of the head and neck.

Also known as: 18F-FSA

Healthy participants; Participants with mild cognitive impairment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Aim 1: Dosimetry group - 8 healthy adult normal volunteers (4 M, and 4 F) will undergo whole-body PET/CT imaging to assess the safety, dosimetry, and metabolism of 18F-FSA. Aim 2: Proof of Concept group - 36 participants (18 healthy and 18 participants with mild cognitive impairment) will undergo 18F-FSA 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-FSA 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 will undergo repeat 18F-FSA, 11C-PIB, MRI, and Cognitive testing.

You may qualify if:

• Male or Female, any race
• Age ≥ 18 years
• Healthy volunteers or volunteers with Alzheimer's disease

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood for future use

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Tammie Benzinger, MD., PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jayashree Rajamanickam

CONTACT

314 273 6140; jayashree.r@wustl.edu

Kelley Jackson

CONTACT

kelleyj@wustl.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiology and Neurological Surgery

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: June 3, 2024
• Study Start: November 7, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 9, 2026

Record last verified: 2026-06

Locations

US (1)