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Evaluate the Use of [18F]-APN-1607 PET in Subjects With AD-related Cognitive Impairment and Subjects With Normal Cognitive Function | Clinical Trials | Clareo Health

RECRUITINGPHASE3

Evaluate the Use of [18F]-APN-1607 PET in Subjects With AD-related Cognitive Impairment and Subjects With Normal Cognitive Function

Phase III Multicenter Clinical Trial Evaluating the Use of [18F]-APN-1607 Injection in Positron Emission Tomography in Subjects With AD-related Cognitive Impairment and Subjects With Normal Cognitive Function

NCT07422857•JYAMS PET Research & Development Limited

View on ClinicalTrials.gov

Summary

This study is to evaluate the efficacy and safety of \[18F\]-APN-1607 Injection in PET imaging for detecting AD-related cognitive impairment.

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Subjects must be able to understand and voluntarily sign a written informed consent form (ICF);
•2. Age ≥ 50 years, regardless of gender;
•3. Subjects with HV, MCI, and AD should meet the clinical diagnostic criteria
•4. Can tolerate brain MRI and PET imaging examinations;
•5. For women of potential fertility (not yet menopausal or within 2 years of menopause), effective contraception must be used during the study and for 3 months after the study (effective contraception refers to sterilization, intrauterine hormonal devices, condoms, birth control pills, abstinence, or partner vasectomy, etc.); male participants should agree to use contraception during the study and for 3 months after the study.

Exclusion Criteria

•1. Specific clinical phenotypes of atypical AD as defined in the 2014 IWG-2 criteria
•2. Possible presence of frontotemporal degeneration (FTLD), characterized by progressive psych behavioral abnormalities and executive dysfunction，Characterized primarily by impairment and language function, progressive aphasia
•3. The core symptoms of Lewy body dementia include fluctuating cognitive changes accompanied by significant attention and arousal abnormalities, recurrent typical visual hallucinations, and spontaneous symptoms of Parkinson's syndrome;
•4. Currently suffering from significant mental illness. Subjects with accompanying psychiatric symptoms need to be carefully evaluated by the researchers to determine whether they can complete the imaging process;
•5. Brain structural abnormalities confirmed by MRI, such as large strokes (infarct area greater than 4 cm) or intracranial space-occupying lesions;
•6. Suffering from claustrophobia or unable to tolerate imaging procedures for other reasons;
•7. History of alcohol or drug abuse/dependency;
•8. Hypersensitivity to the investigational drug or any of its components;
•9. Currently pregnant or breastfeeding;
•10. Received non-vaccine investigational treatment for Alzheimer's disease or other dementia within 3 months prior to screening, or received passive immunotherapy (antibody) for the treatment of Alzheimer's disease or other dementia within 6 months prior to screening, or previously received a vaccine for the treatment of Alzheimer's disease or other dementia; or participated in other new drug clinical trials within 30 days prior to enrollment;
+3 more criteria

Locations (2)

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Huashan Hospital of Fudan University

Shanghai, Province, China

Key Dates

Start Date

January 22, 2026

Primary Completion Date

December 1, 2026

Completion Date

February 1, 2027

Last Updated

February 20, 2026

Enrollment

316

ESTIMATED participants

Conditions

Subjects With Mild Cognitive Impairment (MCI) of AD, Alzheimer's Disease (AD) Dementia

Interventions

[18F]-APN-1607

DRUG