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

NCT06439992 · Washington University School of Medicine
In plain English

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Official title
Beta Amyloid PET Imaging for Alzheimer Disease: [18F]-Fluselenamyl (Alternative Vehicle) Comparison With [11C]-PIB (FSA-PIB AD)
About this study
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 and MRI of the brain 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.
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 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.
Study design
Enrollment target: 60 participants
Age groups: adult, older_adult
Timeline
Starts: 2023-11-07
Estimated completion: 2026-12
Last updated: 2025-06-10
Interventions
Drug: 18F-Fluselenamyl
Primary outcomes
  • To evaluate the safety of the new formulation of Fluselenamy PET Imaging in 8 healthy adult normal volunteers. (Through study completion, an average of 1 year)
  • PET imaging of [18F]-Fluselenamyl in healthy normal control participants and participants with mild cognitive impairment. (Through study completion, an average of 2 years)
Sponsor
Washington University School of Medicine · other
Contacts & investigators
ContactJayashree Rajamanickam · contact · jayashree.r@wustl.edu · 314 273 6140
ContactKelley Jackson · contact · kelleyj@wustl.edu
InvestigatorTammie Benzinger, MD., PhD · principal_investigator, Washington University School of Medicine
All locations (1)
Washington University School of MedicineRecruiting
St Louis, Missouri, United States
Beta Amyloid PET Imaging for Alzheimer Disease With [18F]-Fluselenamyl · TrialPath