Using [18F]-APN-1607 PET scans to detect Alzheimer's-related cognitive changes

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 will test whether [18F]-APN-1607 PET scans can detect Alzheimer's-related brain changes in people aged 50 and older with mild cognitive impairment, Alzheimer's dementia, or normal cognition.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 316 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: JYAMS PET Research & Development Limited (Industry-sponsored)
• Drugs / interventions: immunotherapy
• Locations: 2 sites (Wuhan, Hubei and 1 other locations)
• Trial ID: NCT07422857 on ClinicalTrials.gov

What this trial studies

This Phase 3 interventional trial gives participants an injection of the radiotracer [18F]-APN-1607 followed by PET imaging, with MRI tolerated as part of the imaging protocol. The trial enrolls people with MCI due to AD, AD dementia, and cognitively normal controls to compare PET signal across these groups. Safety monitoring for adverse reactions to the tracer and imaging procedures is included alongside image analysis to determine diagnostic performance. The trial is conducted at academic medical centers in Wuhan and Shanghai.

Who should consider this trial

Good fit: Ideal candidates are people aged 50 or older who have mild cognitive impairment due to AD, AD dementia, or normal cognition, can tolerate MRI and PET scans, and can give informed consent and follow contraception rules where applicable.

Not a fit: People with atypical clinical AD phenotypes, suspected frontotemporal degeneration, those unable to undergo MRI/PET, people under age 50, or those with contraindications to the tracer or imaging are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the tracer could improve imaging of Alzheimer's-related brain changes and help clinicians diagnose and track disease more accurately.

How similar studies have performed: Other PET tracers for Alzheimer's pathology (including amyloid and several tau tracers) have demonstrated utility in detecting disease-related changes, and earlier-phase work with APN-1607 has shown promising imaging results though broader validation is still ongoing.

Eligibility criteria

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.

Where this trial is running

Wuhan, Hubei and 1 other locations

• Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, Hubei, China (Not_yet_recruiting)
• Huashan Hospital of Fudan University — Shanghai, Province, China (Recruiting)

Conditions Subjects With Mild Cognitive Impairment of AD, Alzheimer's Disease Dementia