Using a new imaging agent to study Alzheimer's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research aims to assess the safety of the radiotracer 18F-Fluselenamyl through positron emission tomography (PET) imaging. Initially, whole-body PET dosimetry studies will be conducted in healthy volunteers to determine the radiation dose for human subjects. Following this, brain and neck imaging will be performed on both healthy participants and those with mild cognitive impairment to evaluate the uptake of 18F-Fluselenamyl and its binding to beta-amyloid plaques. The study will also compare the imaging results between normal controls and Alzheimer's disease patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• Washington University School of Medicine
  St Louis, Missouri, United States Recruiting

Study contacts

• Principal investigator: Tammie Benzinger, MD., PhD — Washington University School of Medicine
• Study coordinator: Jayashree Rajamanickam
• Email: jayashree.r@wustl.edu
• Phone: 314 273 6140

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.