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[18F]Florbetazine ([18F]92) for Beta Amyloid PET Imaging in Alzheimer's Disease

NCT06141356 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2023-11-21

No results posted yet for this study

Summary

\[18F\]Florbetazine (\[18F\]92) is a molecularly targeted imaging agent for Aβ protein with a novel diaryl-azine scaffold. It has shown specific binding affinity to Aβ aggregates in postmortem human AD brains and excellent brain pharmacokinetic properties with little non-specific retention in white matter in animal studies and a limited number of patients with Alzheimer's Disease (AD).

The purpose of the current study is to examine the binding properties of \[18F\]Florbetazine in human subjects and to compare the cortical and white matter binding with \[11C\]PiB or \[18F\]Florbetapir in the same subjects.

Imaging of the brain will be completed in healthy adult normal control participants and participants with cognitive impairment (including probable AD and dementia due to other conditions) to characterize \[18F\]Florbetazine uptake in the brain and its binding properties. \[11C\]PIB or \[18F\]Florbetapir PET imaging along with MRI will be completed in the same participants and the data will be compared with 18F-\[18F\]Florbetazine.

Conditions

Interventions

DRUG

[18F]Florbetazine ([18F]92)

Participants will receive a single intravenous bolus injection of 10 mCi ± 20% of the investigational radiotracer \[18F\]Florbetazine and will undergo a PET/CT scan.

DRUG

[11C]PIB

Participants will receive a single intravenous bolus injection of 6.0-20.0mCi of the investigational radiotracer \[11C\]PIB and will undergo a PET/CT scan.

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Eligibility

Min Age
40 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-30
Primary Completion
2024-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06141356 on ClinicalTrials.gov