Menu
Recruiting NCT06439992

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

— Observational Alzheimer Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 18F-Fluselenamyl.
Who it may be relevant to
Registry conditions: Alzheimer Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Beta Amyloid PET Imaging for Alzheimer Disease: [18F]-Fluselenamyl (Alternative Vehicle) Comparison With [11C]-PIB (FSA-PIB AD)

Overview

The purpose of this research study is to determine the safety of a radiotracer 18F-Fluselenamyl using positron emission tomography (PET) imaging.

Detailed description

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.

Interventions

  • Drug 18F-Fluselenamyl
    Participants will receive a single intravenous bolus injection of 10 mCi ± 20% of the investigational radiotracer 18F-Fluselenamyl and will undergo an 18F-Fluselenamyl PET/CT scan of the head and neck.

Primary outcome measures

  • To evaluate the safety of the new formulation of Fluselenamy PET Imaging in 8 healthy adult normal volunteers. [Time frame: Through study completion, an average of 1 year]
  • PET imaging of [18F]-Fluselenamyl in healthy normal control participants and participants with mild cognitive impairment. [Time frame: Through study completion, an average of 2 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

United States · 1 center
  • Washington University School of Medicine — St Louis

Identifiers

NCT: NCT06439992 · FSA-PIB AD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗