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Find more clinical trials

Fluselenamyl Tracer for Amyloid PET Imaging of Alzheimer's Disease

Start: Nov. 18, 2022
End: March 2024
Enrollment: 60

What Is This Study About?

Amyloid is a protein that forms plaques and is one of the hallmarks of Alzheimer's disease. During an amyloid PET brain scan, small amounts of a radioactive tracer are used to visualize amyloid in the brain. This study will test the safety and effectiveness of the radioactive tracer 18F-Fluselenamyl in people with normal cognition or early Alzheimer's. In the first stage of the study, participants with normal cognition will receive whole body PET-CT scans using different amounts of the 18F-Fluselenamyl tracer to determine dosage. In stage 2, all participants will complete cognitive tests and undergo PET imaging of the head and neck with the 18F-Fluselenamyl tracer. For comparison, an MRI scan and PET scan with another tracer, 11C-PIB, will also be collected. After 18 months, the imaging tests in stage 2 will be repeated in all participants. Throughout the study, all participants will be monitored for side effects.

Do I Qualify To Participate in This Study?

Minimum Age: 18 Years

Maximum Age: N/A

Must have:

  • Normal cognition, mild cognitive impairment, or Alzheimer's disease

Must NOT have:

  • Allergy to 18F-Fluselenamyl, 11C-PIB, or any of their components
  • Unwilling or unable to undergo PET scan tracer injections
  • Unwilling or unable to undergo MRI brain scan, including any condition that may make having an MRI brain scan unsafe (e.g., metal shrapnel, heart pacemaker, severe claustrophobia, epilepsy
  • Current or past participation within the last year in another research study involving radioactive agents such that, combined with this study, would exceed safe radiation limits
  • Women must not be pregnant or breastfeeding
  • Any medical condition (e.g., renal or liver failure, advanced cancer) that could:
    • Increase study risk for the participant
    • Limit the participant's ability to tolerate the study procedures, or
    • Interfere with the collection or analysis of the study data

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

 
Study Contact
Jayashree Rajamanickam
Kelley Jackson

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Where Is This Study Located?

Missouri
Washington University School of Medicine
Saint Louis, MO 63110
Recruiting
Jayashree Rajamanickam

Who Sponsors This Study?

Lead: Washington University School of Medicine in St. Louis

Source: ClinicalTrials.gov ID: NCT05731440

 

alzheimers.gov

An official website of the U.S. government, managed by the National Institute on Aging at the National Institutes of Health