Clinical trial NCT06439992: Beta Amyloid PET Imaging for Alzheimer Disease With [18F]-Fluselenamyl
Official title: Beta Amyloid PET Imaging for Alzheimer Disease: [18F]-Fluselenamyl (Alternative Vehicle) Comparison With [11C]-PIB (FSA-PIB AD)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alzheimer Disease
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2024-06-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Aim 1: Dosimetry group - 8 healthy adult normal volunteers (4 M, and 4 F) will undergo whole-body PET/CT imaging to assess the safety, dosimetry, and metabolism of 18F-FSA.

Aim 2: Proof of Concept group - 36 participants (18 healthy and 18 participants with mild cognitive impairment) will undergo 18F-FSA imaging of the brain and neck, 11C-PIB imaging of the brain and neck, MRI, and Cognitive testing.

Aim 3: Performance group- Aim 2 participants will be invited for additional imaging.

Aim 3A- 10 participants from Aim 2 will undergo repeat 18F-FSA imaging \~ 1 month after baseline imaging

Aim 3B- 18 participants from Aim 2 will have a longitudinal follow-up visit \~ 18 months after the initial study. They will undergo repeat 18F-FSA, 11C-PIB, MRI, and Cognitive testing.

Brief summary: 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.

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.

Primary outcomes:
measure: To evaluate the safety of the new formulation of Fluselenamy PET Imaging in 8 healthy adult normal volunteers.
timeFrame: Through study completion, an average of 1 year
measure: PET imaging of [18F]-Fluselenamyl in healthy normal control participants and participants with mild cognitive impairment.
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Tammie Benzinger, MD., PhD
role: PRINCIPAL_INVESTIGATOR
References: