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NCT05731440 · ClinicalTrials.gov registry record
Fluselenamyl - Beta Amyloid PET Imaging for Alzheimer Disease
A clinical trial of Alzheimer Disease, sponsored by Washington University School of Medicine.
- Active
- Registry status
- 60
- Enrollment target
- 1
- Study location
NCT05731440: Active study of Alzheimer Disease, sponsored by Washington University School of Medicine.
NCT05731440 is a study of Alzheimer Disease that is active but no longer recruiting, run by Washington University School of Medicine. The registered enrollment target is 60 participants, below the 2,751-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05731440, a study of Alzheimer Disease, is active but no longer recruiting, sponsored by Washington University School of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this research study is to determine the safety of a radiotracer 18F-Fluselenamyl using positron emission tomography (PET) imaging. 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 along with MRI 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.
Primary Outcome
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 objective is to evaluate the biodistribution, kinetics and calculate human dosimetry of this radioligand and confirm it's lack of toxicity in human subjects.
Conditions Studied
Interventions
- DRUG 18F-Fluselenamyl
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2022-11-18 |
| Est. Completion | 2026-12 |
What the registry record for NCT05731440 still lists
NCT05731440 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 2,751-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Alzheimer Disease appearing as the primary indexed condition, and to 1 intervention - of which 18F-Fluselenamyl is the first listed.
NCT05731440 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT05731440 about?
NCT05731440 is a clinical study titled "Fluselenamyl - Beta Amyloid PET Imaging for Alzheimer Disease". The purpose of this research study is to determine the safety of a radiotracer 18F-Fluselenamyl using positron emission tomography (PET) imaging. The investigators will first complete whole-body PET dosimetry studies in healthy adult normal volunteers to calculate the actual radiation dose of each ...
What is the current status of trial NCT05731440?
This trial is currently active not recruiting. The enrollment target is 60 participants. The study started on 2022-11-18. Estimated completion is 2026-12.
What conditions does trial NCT05731440 study?
This clinical trial studies the following conditions: Alzheimer Disease.
What interventions are being tested in trial NCT05731440?
The interventions under investigation include: 18F-Fluselenamyl (DRUG).
Who is sponsoring clinical trial NCT05731440?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05731440 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alzheimer Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05731440's enrollment target sits among peer trials
60 187th of 306 higher than 108 of 306 other Alzheimer Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimer Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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