Beta Amyloid PET Imaging for Alzheimer Disease: [18F]-Fluselenamyl (Alternative Vehicle) Comparison With [11C]-PIB (FSA-PIB AD)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- To evaluate the safety of the new formulation of Fluselenamy PET Imaging in 8 healthy adult normal volunteers.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Healthy participants
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.
Intervention: 18F-Fluselenamyl (Drug)
Participants with mild cognitive impairment
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.
Intervention: 18F-Fluselenamyl (Drug)
Outcomes
Primary Outcomes
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
Whole-body PET/CT images (skull vertex to proximal thighs) will be obtained in 8 healthy volunteers (4 males and 4 females) for up to a maximum of 4.5 hours immediately following intravenous (IV) injection of 10 mCi ± 20% of \[18F\]-Fluselenamyl (dosage range calculated from rodent dosimetry data extrapolated to humans). The primary outcome measure is to quantify each organ's radiation exposure (rad/mCi).
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
To assess the sensitivity of \[18F\]-Fluselenamyl to image Amyloid beta in the setting of mild cognitive impairment, and conduct a comparative analysis of PET imaging data using \[11C\]-PIB imaging in the same participants.
Secondary Outcomes
No secondary outcomes reported
Investigators
Tammie L. S. Benzinger, MD, PhD
Professor of Radiology and Neurological Surgery
Washington University School of Medicine