Fluselenamyl - Beta Amyloid PET Imaging for Alzheimer Disease

NCT ID: NCT05731440

Last Updated: 2025-06-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-18
• Study Completion Date: 2026-12-31

Brief 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.

Conditions

Alzheimer Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

18F-Fluselenamyl

Intervention Type: 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.

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.

18F-Fluselenamyl

Intervention Type: 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.

Interventions

18F-Fluselenamyl

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.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Tammie L. S. Benzinger, MD, PhD

Professor of Radiology and Neurological Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Other Identifiers

Fluselenamyl (FSA)

Identifier Type: -

Identifier Source: org_study_id