Alzheimer's DiseasePhase 3NCT07752784
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.
A Phase 3 study testing [18F]-APN-1607 in people with Alzheimer's Disease, run by JYAMS PET Research & Development Limited at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- [18F]-APN-1607
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2026to 15 Aug 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 join
- 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 participating in any investigational clinical trial.
- Previous participation in clinical studies of amyloid or tau-targeting agents.
- Suspected hepatic encephalopathy.
- Allergy to the investigational drug or any of its components.
- Currently pregnant or breastfeeding.
- Currently having a disease or condition that prolongs the QT interval.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
Yan li Zhang, 010-5997-5698, centralbrainbank@ncrcnd.org.cn
Yue Huang, Ph.D
About this study
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.
- 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.
- 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.
- To evaluate the safety of [18F]-APN-1607 injection.
- Conditions
- Alzheimer's Disease
- Being tested
- [18F]-APN-1607
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]-APN-1607Drug
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
| Study group | Role | What they receive |
|---|---|---|
| Cognitively Normal (HV) | Experimental | Cognitively Normal will undergo PET imaging using [18F]-APN-1607 Receives: Drug: [18F]-APN-1607 |
| Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI) | Experimental | Alzheimer's Disease or Mild Cognitive Impairment subjects will undergo PET imaging using [18F]-APN-1607 Receives: Drug: [18F]-APN-1607 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the consistency between the visual interpretation results of [18F]-APN-1607 injection PET imaging and the authenticity standards.
Summary of visual reads by 5 blinded readers and concordance analysis between NIA-AA postmortem neuropathology and [18F]-APN-1607 PET visual reads.
Measured: 8 months
Secondary outcomes (2)
Correlation between the results of semi-quantitative PET imaging analysis (SUVR) and brain tissue pathological NFT scores.
Correlation analysis between categorized NFT scores and regional PET SUVRs
Measured: 8 months
Evaluation of the safety of [18F]-APN-1607 injection.
Safety for the administration of [18F]-APN-1607 and PET scanning is measured by number of participants with Adverse events / Serious adverse events
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start15 Aug 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion15 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JYAMS PET Research & Development Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07752784
- Sponsor's protocol ID
- DCAMS-F10-303
- Status last verified
- Aug 2026
- First submitted
- 29 Jul 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07752784
- Acronym / sponsor ID
- DCAMS-F10-303
- Conditions
- Alzheimer's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- JYAMS PET Research & Development LimitedIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 15 Aug 2027 (estimated)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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.
- To evaluate the safety of [18F]-APN-1607 injection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitively Normal (HV) | Experimental | Drug: [18F]-APN-1607Cognitively Normal will undergo PET imaging using [18F]-APN-1607 |
| Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI) | Experimental | Drug: [18F]-APN-1607Alzheimer's Disease or Mild Cognitive Impairment subjects will undergo PET imaging using [18F]-APN-1607 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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 participating in any investigational clinical trial.
- Previous participation in clinical studies of amyloid or tau-targeting agents.
- Suspected hepatic encephalopathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]-APN-1607Participants 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 | Drug | Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI), Cognitively Normal (HV) |
Primary outcome
Evaluate the consistency between the visual interpretation results of [18F]-APN-1607 injection PET imaging and the authenticity standards.
Time frame: 8 months
Summary of visual reads by 5 blinded readers and concordance analysis between NIA-AA postmortem neuropathology and [18F]-APN-1607 PET visual reads.
2 secondary outcomes
Correlation between the results of semi-quantitative PET imaging analysis (SUVR) and brain tissue pathological NFT scores.
Time frame: 8 months
Evaluation of the safety of [18F]-APN-1607 injection.
Time frame: 8 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing [18F]-APN-1607 in people with Alzheimer's Disease, run by JYAMS PET Research & Development Limited at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qian Tang (025-86166196, tangqian@pet-tracer.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the consistency between the visual interpretation results of [18F]-APN-1607 injection PET imaging and the authenticity standards. (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.