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A Clinical Study Evaluating the Diagnostic Performance and Safety of PET for the Deposition of Aβ Plaques in the Brain of Participants With Normal Cognitive Function, MCI and AD Using [18F]Fluorbetazine Injection

NCT07764679 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-08-14

No results posted yet for this study

Summary

A multicenter phase III clinical study evaluating the diagnostic performance and safety of PET for the deposition of Aβ plaques in the brain of participants with normal cognitive function, MCI and AD using \[18F\]Fluorbetazine injection.

Conditions

  • Mild Cognitive Impairment (MCI)
  • Alzheimer's Disease (AD)

Interventions

DRUG

[18F]Fluorbetazine injection

normal cognitive function, mild cognitive impairment (MCI) caused by Alzheimer's disease (AD) using \[18F\]Fluorbetazine injection.

Sponsors & Collaborators

  • HTA Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-20
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

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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 NCT07764679 on ClinicalTrials.gov