Beta Amyloid PET Imaging for Alzheimer Disease With [18F]-Fluselenamyl
Purpose
The purpose of this research study is to determine the safety of a radiotracer 18F-Fluselenamyl using positron emission tomography (PET) imaging.
Condition
- Alzheimer Disease
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible 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.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Case-Control
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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. |
|
| 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. |
|
Recruiting Locations
Washington University in St. Louis and nearby locations
St Louis 4407066, Missouri 4398678 63110
More Details
- NCT ID
- NCT06439992
- Status
- Recruiting
- Sponsor
- Washington University School of Medicine
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.