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Taking people in ChinaPhase 3

Compares a brain PET scan tracer with tau changes in brain tissue

Tests a PET scan tracer against brain tissue findings in people with memory decline.

Key facts

Who runs it
JYAMS PET Research & Development Limited
Where
Beijing, ChinaSee the site
Trial code
Registry title
Evaluate the Concordance Between PET Imaging of [18F]-APN-1607 Injection and Postmortem Brain Tissue Tau Pathology in Individuals With HV and MCI or AD.
Status
Recruiting
Phase
Phase 3
People taking part
12 people, planned
Started
15 Aug 2026
Expected to end
15 Aug 2027
Type of study
Interventional, 2 groups
Treatments tested
  • [18F]-APN-1607
Record updated
17 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 50 or older who are either cognitively normal or have mild cognitive impairment or Alzheimer's dementia. It checks a brain PET scan against brain tissue after death.

Age
50 years or older
Sex
Men and women
Disease stage
Healthy volunteers with no personal or family history of Alzheimer's-type dementia, or people clinically diagnosed with mild cognitive impairment or dementia due to Alzheimer's disease.
Earlier treatment
People who took part in earlier studies of amyloid or tau drugs cannot join.

Main reasons for not taking part

  • Brain structure problems that could affect the PET scan, such as a large stroke (infarct area over 4 cm (1.6 in)) or a space-occupying lesion in the skull
  • Current clinically significant infection, such as HIV or hepatitis
  • Taking part in another investigational trial now
  • Pregnant or breastfeeding
  • A condition that prolongs the QT interval

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • Able to understand and voluntarily sign a written informed consent form (ICF)
  • Age≥50 years, male or female
  • Charlson Comorbidity Index (CCI)≥5
  • Able to tolerate imaging procedures
  • For MCI or AD subjects: clinically diagnosed as AD-derived cognitive impairment or Alzheimer's dementia
  • For HV subjects: no known personal or family history of AD-derived dementia

Who cannot take part

  • Previous participation in clinical studies of amyloid or tau-targeting agents
  • Allergy to the investigational drug or any of its components
  • Confirmed brain structural abnormalities that may affect PET reading, e.g., large stroke (infarct area>4 cm) or intracranial space-occupying lesion
  • Currently having clinically significant infectious diseases: HIV, hepatitis, etc
  • Currently having a disease or condition that prolongs the QT interval
  • Currently participating in any investigational clinical trial
  • Suspected hepatic encephalopathy
  • Currently pregnant or breastfeeding

Where in China

  • Beijing Tiantan Hospital,Capital Medical UniversityBeijing, ChinaContact: Yan li ZhangTaking people

About the trial

What the trial wants to find out

1. To evaluate the diagnostic performance of [18F]-APN-1607 injection PET imaging in detecting uptake patterns consistent with AD neuropathological changes as defined by the National Institute on Aging-Alzheimer's Association (NIA-AA) criteria. 2. To assess the association between [18F]-APN-1607 injection and Alzheimer's disease (AD)-related tau neurofibrillary pathology (as determined by post-mortem brain tissue histopathology), and detect the uptake pattern corresponding to neurofibrillary tangle (NFT) scores. 3. To evaluate the safety of [18F]-APN-1607 injection.

The 2 groups in the trial

  • Cognitively Normal (HV)Treatment being tested

    Cognitively Normal will undergo PET imaging using \[18F\]-APN-1607

    Treatment: [18F]-APN-1607

  • Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI)Treatment being tested

    Alzheimer's Disease or Mild Cognitive Impairment subjects will undergo PET imaging using \[18F\]-APN-1607

    Treatment: [18F]-APN-1607

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Clinicopathological Study to Evaluate the Concordance Between [18F]-APN-1607 Injection PET Imaging and Post-mortem Brain Tau Protein Pathological Changes in Cognitively Normal (HV) Subjects and Patients With AD-derived Mild Cognitive Impairment (MCI) or Alzheimer's Disease (AD) Dementia.
Plain-language title
Compares a brain PET scan tracer with tau changes in brain tissueGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Record updated
17 August 2026