Beta Amyloid PET Imaging for Alzheimer Disease With [18F]-Fluselenamyl

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT06439992
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 18F-Fluselenamyl — DRUG
    Participants will receive a single intravenous bolus injection of 10 mCi ± 20% of the investigational radiotracer 18F-Fluselenamyl and will undergo an 18F-Fluselenamyl PET/CT scan of the head and neck.

Study Details

The purpose of this research study is to determine the safety of a radiotracer 18F-Fluselenamyl using positron emission tomography (PET) imaging.

Key Dates

Start date
Nov 7, 2023
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Jayashree Rajamanickam
[email protected]
314 273 6140
Kelley Jackson
[email protected]
314 362 3613

Find similar trials in St Louis, MO

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Washington University School of Medicine· St Louis, MO

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