[18F]Fluorbetazine injection / Alzheimer's Disease (AD) / Mild Cognitive Impairment (MCI) · Phase 3 Trial

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

ClinicalTrials.gov · August 14, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a planned Phase 3 multicenter study registration evaluating [18F]Fluorbetazine PET imaging for detection of amyloid-β plaques across cognitive normal, MCI, and Alzheimer's disease populations. No results are reported in this registry record; the study is currently recruiting participants.

What was studied

Phase 3, Interventional, Single Group, Open label, Diagnostic purpose. Mild Cognitive Impairment (MCI), Alzheimer's Disease (AD); age from 40 Years; accepts healthy volunteers. Intervention: using [18F]Fluorbetazine injection.. n = 400. 1 site: China.

Key findings

Primary outcome: sensitivity and specificity of PET visual interpretation compared to true standards after single IV injection of [18F]Fluorbetazine in AD, MCI, and normal cognitive participants Planned enrollment: 400 participants (estimated) Study duration: 1 year follow-up for primary outcomes

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a clinical trial registry record describing a planned Phase 3 study with no results yet reported; enrollment is ongoing and primary outcomes have not been assessed.

Study design

As stated by the source record.

MethodsPrimary outcome measure: The sensitivity and specificity of PET imaging visual interpretation results compared to true standards after a single intravenous injection of [18F]Fluorbetazine injection in par… (assessed at 1 year)

DesignPhase 3, Interventional, Single Group, Open label, Diagnostic purpose

PopulationMild Cognitive Impairment (MCI), Alzheimer's Disease (AD); age from 40 Years; accepts healthy volunteers

Sample size400

Interventionusing [18F]Fluorbetazine injection.

Setting1 site: China

Reported figures

Quoted from the source exactly as published.

Planned sample size400

Primary outcome measureSensitivity and specificity of PET imaging visual interpretation versus true standards

Primary outcome timeframe1 year

Study phasePhase 3

Caveats

Registry record only; no results reported. Study is currently recruiting.
Per-arm or per-group sample sizes not specified; total enrollment is estimated at 400.
Study methods, randomization, blinding, and control group definition not detailed in registry record.
True standard or reference comparator against which sensitivity and specificity will be measured is not specified.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 3 multicenter interventional design planned; prospective with control comparisons implied.

Directness

strong

Direct evaluation of diagnostic performance against true standards in target populations.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record alone.

Risk of bias

insufficient

Study methods and blinding procedures not described in registry record.

Sample adequacy

moderate

Estimated enrollment of 400 participants across three diagnostic groups; specific per-group sizes not stated.

Source abstract

Registry record from ClinicalTrials.gov (NCT07764679). This is a study registration, not published results. Lead sponsor: HTA Co., Ltd.. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 400 participants (ESTIMATED). Conditions: Mild Cognitive Impairment (MCI), Alzheimer's Disease (AD). Interventions: DRUG: [18F]Fluorbetazine injection. Primary outcome measures: The sensitivity and specificity of PET imaging visual interpretation results compared to true standards after a single intravenous injection of [18F]Fluorbetazine injection in participants with AD induced MCI, AD dementia and normal cognitive. , 1 year. Brief 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

NCT07764679HTA Co.[18F]Fluorbetazine injectionAlzheimer's Disease (AD)Mild Cognitive Impairment (MCI)