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

The Washington University

Status: Enrolling

Conditions: Alzheimer Disease

Treatments: Drug: 18F-Fluselenamyl

Study type: Observational

Funder types: Other

Identifiers

NCT06439992

FSA-PIB AD

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

60 participants in 2 patient groups

Healthy participants

Description:

Healthy participants with normal cognition will be recruited and receive the following interventions: Drug: \[18F\]-Fluselenamyl. A dosage range of 10 mCi +/- 20% of Fluselenamyl will be injected by a PET-certified medical professional followed by 10 ml 0.9% sodium chloride (normal saline) flush. Drug: \[11C\]-Pittsburgh Compound (\[11C\]PIB) A dosage range between 6.0-20.0 mCi is planned. A PET-certified professional will prepare and administer the \[11C\]-PIB tracer. Participants will receive the PIB injection followed by a 10 ml 0.9% sodium chloride (normal saline) flush.

Treatment:

Drug: 18F-Fluselenamyl

Participants with mild cognitive impairment

Description:

Participants with mild cognitive impairment will be recruited and receive the following interventions: Drug: \[18F\]-Fluselenamyl. A dosage range of 10 mCi +/- 20% of Fluselenamyl will be injected by a PET-certified medical professional followed by 10 ml 0.9% sodium chloride (normal saline) flush. Drug: \[11C\]-Pittsburgh Compound (\[11C\]PIB) A dosage range between 6.0-20.0 mCi is planned. A PET-certified professional will prepare and administer the \[11C\]-PIB tracer. Participants will receive the PIB injection followed by a 10 ml 0.9% sodium chloride (normal saline) flush.

Treatment:

Drug: 18F-Fluselenamyl