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NCT07422857RecruitingPhase 3

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

Source: ClinicalTrials.gov · Last updated 20 Feb 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
316 (estimated)
First submitted
29 Jan 2026
Start date
22 Jan 2026
Primary completion date
1 Dec 2026
Lead sponsor
JYAMS PET Research & Development Limited
NCT number
NCT07422857

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 316
  • From 22 Jan 2026 to the primary completion date, 1 Dec 2026
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Hypersensitivity to the investigational drug or any of its components;
  • 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;

Other illness

  • Possible presence of frontotemporal degeneration (FTLD), characterized by progressive psych behavioral abnormalities and executive dysfunction,Characterized primarily by impairment and language function, progressive aphasia
  • 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;
  • 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;
  • History of alcohol or drug abuse/dependency;
  • 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

Lab values

  • 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

Other

  • Specific clinical phenotypes of atypical AD as defined in the 2014 IWG-2 criteria
  • Brain structural abnormalities confirmed by MRI, such as large strokes (infarct area greater than 4 cm) or intracranial space-occupying lesions;
  • Suffering from claustrophobia or unable to tolerate imaging procedures for other reasons;
  • Currently pregnant or breastfeeding;
  • There are other situations that researchers consider unsuitable for participating in the experiment.

Who the study is looking for

  • Subjects must be able to understand and voluntarily sign a written informed consent form (ICF);
  • Age ≥ 50 years, regardless of gender;
  • Subjects with HV, MCI, and AD should meet the clinical diagnostic criteria
  • Can tolerate brain MRI and PET imaging examinations;
  • 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.

Age in the registry: 50 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Huashan Hospital of Fudan University
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Coordinator of this site? Confirm its status
WuhanChinaNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.