Beta Amyloid PET Imaging for Alzheimer Disease With [18F]-Fluselenamyl
- Registration Number
- NCT06439992
- Lead Sponsor
- Washington University School of Medicine
- 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.
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Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Male or Female, any race
- Age ≥ 18 years
- Healthy volunteers or volunteers with Alzheimer's disease
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants with mild cognitive impairment 18F-Fluselenamyl 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. Healthy participants 18F-Fluselenamyl 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.
- Primary Outcome Measures
Name Time Method To evaluate the safety of the new formulation of Fluselenamy PET Imaging in 8 healthy adult normal volunteers. 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).
...PET imaging of [18F]-Fluselenamyl in healthy normal control participants and participants with mild cognitive impairment. 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 Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States