RecruitingNCT06439992

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

Beta Amyloid PET Imaging for Alzheimer Disease: [18F]-Fluselenamyl (Alternative Vehicle) Comparison With [11C]-PIB (FSA-PIB AD)

Sponsor

Washington University School of Medicine

Enrollment

60 participants

Start Date

Nov 7, 2023

Study Type

OBSERVATIONAL

Conditions

Alzheimer Disease

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria3

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

Exclusion Criteria8

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.

Interventions

DRUG18F-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 of the head and neck.