← Back to all trials
Recruiting
NCT05731440
Fluselenamyl - Beta Amyloid PET Imaging for Alzheimer Disease
Conditions: Alzheimer Disease
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Enrollment: 60
Sponsor: Washington University School of Medicine
Location: United States
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.
Eligibility Criteria
Inclusion Criteria:Male or Female, any raceAge ≥ 18 yearsHealthy volunteers or volunteers with Alzheimer's diseaseExclusion 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.
Source: ClinicalTrials.gov (NCT05731440). StuddyBuddy aggregates publicly available trial information.