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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: PET scans, MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of 18F-Fluselenamyl, a radioactive tracer used in PET scans to make pictures inside the body. It is for adults who are healthy or have Alzheimer's disease.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Male or female, of any race.
  • Healthy or have Alzheimer's disease.

Who can't join

  • Allergic to 18F-Fluselenamyl or any of its ingredients.
  • Allergic to 11C-PIB, another tracer, or any of its ingredients.
  • Unable to give written consent and do not have a legally approved person who can give consent for you.
  • Unwilling or unable to have PET scans or tracer injections.
  • Unwilling or unable to have an MRI scan for study parts 2 and 3.
  • Have a condition that the study doctor thinks could make the study unsafe, make procedures hard to handle, or affect the study results, such as kidney or liver failure or advanced cancer.
  • Currently pregnant or breastfeeding.
  • Taking part now, or within the past 12 months before screening, in research using radioactive substances that would put your yearly research radiation exposure above U.S. legal limits.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

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