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

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

Study Overview

• Status: Recruiting
• Conditions: Subjects With Mild Cognitive Impairment (MCI) of AD, Alzheimer's Disease (AD) Dementia
• Intervention / Treatment: Drug: [18F]-APN-1607

• Study Type: Interventional
• Enrollment (Estimated): 316
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Not yet recruiting
      • Union Hospital Tongji Medical College Huazhong University of Science and Technology
  • Province
    • Shanghai, Province, China, 201199
      • Recruiting
      • Huashan Hospital of Fudan University
      • Contact: Jintai Yu, M.D.; Phone Number: 021-52889999; Email: jintai_yu@fudan.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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;
11. At present, the researcher suffers from serious diseases, such as infectious diseases, infectious diseases, endocrine or metabolic diseases, as well as serious cardiac function, liver function, lung function, and kidney function damage, and believes that participation in this study will have adverse effects on the subject or the research results
12. Currently suffering from a disease or factor that causes QT interval prolongation, including torsades de pointes, QT prolongation syndrome, hyperkalemia, hypocalcemia, or taking medications that can prolong the QT interval, such as quinidine, amiodarone, or sotalol
13. There are other situations that researchers consider unsuitable for participating in the experiment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alzheimer's Disease; AD subjects will undergo PET imaging using [18F]APN-1607.	Drug: [18F]-APN-1607; Participants will receive a single intravenous injection of 5-7 mCi of [18F]-APN-1607, and a whole-body PET/CT scan will begin immediately after administration.
Experimental: Mild Cognitive Impairment Due to Alzheimer's Disease; MCI subjects will undergo PET imaging using [18F]APN-1607.	Drug: [18F]-APN-1607; Participants will receive a single intravenous injection of 5-7 mCi of [18F]-APN-1607, and a whole-body PET/CT scan will begin immediately after administration.
Other: Healthy Volunteers; Healthy control subjects will undergo PET imaging using [18F]APN-1607.	Drug: [18F]-APN-1607; Participants will receive a single intravenous injection of 5-7 mCi of [18F]-APN-1607, and a whole-body PET/CT scan will begin immediately after administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the effectiveness of visual reading results of [18 F]-APN-1607 injection PET imaging in detecting tau NFTs（Neurofibrillary Tangles）	Sensitivity and specificity of PET imaging visual interpretation results of [ 18 F]-APN-1607 injection compared with true standards	15 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of [18 F]-APN-1607 Uptake Patterns by Regional SUVR Values and the capability in differentiating different groups	Based on [18F]-APN-1607 PET, the sensitivity and specificity of area under the curve (AUC) with semi-quantitative analysis of standardized uptake values (SUVR) of brain regions of comprehensive interest (iROI) in the brain to distinguish HV subjects from AD-related cognitive impairment subjects (MCI+AD), as well as MCI subjects from AD subjects.	15 months
Safety and Tolerability Profile Measured by Adverse Events (AEs)	Safety for theadministration of [18F]APN-1607 and PET scanning is measured by number of participants with Adverse events / Serious adverse events	15 months

Collaborators and Investigators

• Sponsor: JYAMS PET Research & Development Limited

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: January 29, 2026
• First Submitted That Met QC Criteria: February 13, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease; Dementia
• Other Study ID Numbers: DCAMS-F10-302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No