ACTIVE_NOT_RECRUITING

Fluselenamyl - Beta Amyloid PET Imaging for Alzheimer Disease

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Fluselenamyl - Beta Amyloid PET Imaging for Alzheimer Disease

Quick Facts

Study Start:2022-11-18
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05731440

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or Female, any race
  2. * Age ≥ 18 years
  3. * Healthy volunteers or volunteers with Alzheimer's disease
  1. * Has hypersensitivity to 18F-Fluselenamyl or any of its excipients ;
  2. * Has hypersensitivity to 11C-PIB or any of its excipients ;
  3. * Incapable of providing written informed consent or lacking a legally authorized representative (LAR) to provide informed consent ;
  4. * Unwilling or unable to undergo PET scans tracer injections ;
  5. * Unwilling or unable to undergo MRI (Aim 2 and Aim 3);
  6. * 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);
  7. * Women who are currently pregnant or breast-feeding;
  8. * 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.

Contacts and Locations

Study Locations (Sites)

Washington University School of Medicine
Saint Louis, Missouri, 63110
United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-18
Study Completion Date2026-12

Study Record Updates

Study Start Date2022-11-18
Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

  • Alzheimer Disease