Actively Recruiting

Phase 3
Age: 50Years +
All Genders
Healthy Volunteers
NCT07422857

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

Led by JYAMS PET Research & Development Limited · Updated on 2026-02-20

316

Participants Needed

2

Research Sites

53 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 50Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to understand and voluntarily sign informed consent
  • Age 50 years or older, any gender
  • Diagnosed with healthy volunteer status, mild cognitive impairment, or Alzheimer's disease according to clinical criteria
  • Able to tolerate brain MRI and PET imaging examinations
  • Women of childbearing potential must use effective contraception during and for 3 months after the study; male participants must agree to contraception during and for 3 months after the study
Not Eligible

You will not qualify if you...

  • Atypical Alzheimer's disease clinical phenotypes as defined by 2014 IWG-2 criteria
  • Possible frontotemporal degeneration with progressive behavioral and language impairments
  • Symptoms of Lewy body dementia including fluctuating cognition and Parkinsonian signs
  • Significant mental illness or psychiatric symptoms interfering with imaging
  • Brain abnormalities such as large strokes or space-occupying lesions seen on MRI
  • Claustrophobia or inability to tolerate imaging procedures
  • History of alcohol or drug abuse or dependency
  • Hypersensitivity to the investigational drug or its components
  • Currently pregnant or breastfeeding
  • Received investigational Alzheimer's or dementia treatments within specified recent time frames
  • Serious infectious, endocrine, metabolic, cardiac, liver, lung, or kidney diseases
  • Conditions or medications causing QT interval prolongation
  • Any other conditions judged by researchers as unsuitable for participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China, 430000

Not Yet Recruiting

2

Huashan Hospital of Fudan University

Shanghai, Province, China, 201199

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

3

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