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 | Recruiting Phase 3

• 2 other identifiers: HJG-YZGK-FBTQHTA Co., Ltd.
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

Secondary Outcomes (3)

• 1 Calculate and compare the standard uptake value ratio (SUVR) of cortical target areas (lateral temporal lobe, frontal lobe, posterior cingulate gyrus/anterior cingulate cortex, and parietal lobe) relative to the cerebellum between AD derived MCI/AD dem

  1year

• 2 Using Kappa coefficient to compare the consistency of visual analysis of PET imaging among independent readers, within readers, and overall

  1year

• 3 Calculate the cerebral gray matter to white matter SUV ratio (GWR) on PET images of AD derived MCI/AD dementia participants and cognitively normal participants, and evaluate image features.

  1year

Other Outcomes (1)

• The safety assessment is based on serious adverse events, adverse events

  From the first day of application to one week after administration

Study Arms (1)

using [18F]Fluorbetazine injection.

EXPERIMENTAL

Drug: [18F]Fluorbetazine injection

Interventions

[18F]Fluorbetazine injection DRUG

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

using [18F]Fluorbetazine injection.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women aged ≥ 40 years (including the threshold age). 2. Men or women with fertility must use effective contraceptive measures during the study period. Effective contraceptive measures include sterilization, intrauterine hormone devices, condoms, birth control pills, abstinence, or vasectomy.
• \. Meet the diagnostic criteria for normal cognitive function, Mild Cognitive Impairment (MCI), or Alzheimer's disease (AD).
• \. Participants voluntarily join the study, can cooperate with the experimental observations, and sign a written informed consent form. For participants with AD dementia, the informed consent form must be signed together with their legal guardian. If the participant is unable to sign the informed consent form due to limited cognitive ability or other reasons, the participant's signature space may be left blank, with the reason documented. The guardian should sign in the designated space for explanation.

You may not qualify if:

• Known allergy to \[18F\]Fluorbetazine injection or its excipients.
• Presence of previously implanted metal devices that are incompatible with MRI examinations, including pacemakers, defibrillators, insulin pumps, cochlear implants, intraocular metal implants, nerve stimulators, or CNS aneurysm clips; or suffering from claustrophobia or intolerance to imaging procedures for other reasons.
• Cognitive impairment caused by reasons other than Alzheimer's disease (AD).
• Cranial MRI scan shows one or more of the following results:
• More than 2 infarctions with a diameter greater than 2 cm in any part of the brain;
• Infarctions of any diameter in key areas such as the thalamus, hippocampus, entorhinal cortex, hippocampal gyrus, gyrus, cortex, or other subcortical gray matter nuclei;
• Fazekas Scale grading of white matter lesions \> 2;
• Presence of brain tumors, intracranial infections, or cerebral hemorrhage, and deemed unsuitable for participation in this study by the researchers.
• Current clinically significant psychiatric illnesses, such as severe depression or schizophrenia, based on medical history, and the researchers have assessed that the imaging process cannot be completed. Researchers should carefully consider whether participants with dementia and behavioral disorders who may require psychiatric medication can complete the imaging process.
• Received radiopharmaceutical imaging or treatment within at least 5 half-lives prior to screening.
• Suffering from other serious and/or poorly controlled and/or unstable diseases, and deemed unsuitable for participation in this study by the researcher.
• Positive test results for human immunodeficiency virus (HIV) antibodies or Treponema pallidum antibodies.
• History of alcohol or drug abuse.
• Pregnant or lactating women with positive pregnancy test results during the screening period (including premenopausal women who have not undergone surgical sterilization and women within one year after menopause).
• Participated in any clinical trials within 4 weeks prior to enrollment and used investigational drugs; or those who plan to participate in any clinical trials during the study period.

Sponsors & Collaborators

• HTA Co., Ltd.: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 102413, China

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Xiaomin Xu, Master

CONTACT

010-69357316; xuxiaomin@circ.com.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: August 14, 2026
• Study Start: June 20, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)