ClinicalTrials.gg
RecruitingNCT07752784Updated Aug 17, 2026

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 interventional study of [18F]-APN-1607 in Alzheimer's Disease, sponsored by JYAMS PET Research & Development Limited. Recruiting at 1 site in China. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-17.

Sponsored by JYAMS PET Research & Development Limited · Phase 3, Interventional, and Diagnostic

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Phase
Phase 3
Study type
Interventional
Enrollment
12
Allocation
Non-randomized
Ages
50 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 260 studies in Alzheimer Disease with a site in China — 150 open to participants now, 162 under way, 21 of them phase 3. Alzheimer Disease · China.

Planned enrollment
165th of 176
12 · median 100
Started
2026
with 35 others
Phase 3
33 of 260
15 open now
Primary completion
2027-04
later than 73 of 161 live
Registered
245th of 260
by date

Among the 260 studies in Alzheimer Disease with a site in China, this one is the 165th largest by planned enrollment of the 176 interventional ones that give a count, is one of 36 that started in 2026, is one of 33 in phase 3, reaches primary completion later than 73 of the 161 other live ones, and was the 245th registered.

Alzheimer Disease

3,967 studies on the registry are indexed under Alzheimer Disease; 928 are open to participants now.

Browse Alzheimer Disease studies →

Open to participants now

150 of the 260 studies in Alzheimer Disease with a site in China are open now. Recruiting first, the newest first:

144 more — sign in →

All 150 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 642 Alzheimer Disease studies recruiting now, 283 (44%) set no upper age limit and 55 (9%) stop at 75 or younger; 34 take children under 18; 284 take healthy volunteers.

This study: 50 Years and older · all sexes · healthy volunteers too.

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02

Study 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. 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.
03

Conditions studied

  • Alzheimer's Disease

Browse trials for

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Confirmed brain structural abnormalities that may affect PET reading, e.g., large stroke (infarct area>4 cm) or intracranial space-occupying lesion.
  2. Currently having infectious diseases: , hepatitis, etc.
  3. Currently participating in any clinical trial.
  4. Previous participation in clinical studies of amyloid or tau-targeting agents.
  5. Suspected hepatic encephalopathy.
  6. Allergy to the investigational drug or any of its components.
  7. Currently pregnant or breastfeeding.
  8. Currently having a disease or condition that prolongs the .
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

05

Study design

Phase
Phase 3
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    Cognitively Normal (HV)

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

    Drug: [18F]-APN-1607

  • Experimental
    Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI)

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

    Drug: [18F]-APN-1607

Interventions

  • 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 8 months

Secondary outcomes

  1. 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

    Time frame: 8 months

  2. 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

    Time frame: 8 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2026; primary completion for Apr 2027, 8 months later.

Of 75 industry-sponsored phase 3 interventional studies under Alzheimer Disease, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 61. This study's planned 8 months is below that.

Counting every sponsor, half of 101 studies reached it within 47 months; a quarter within 28 and three quarters within 73.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 29, 2026
First posted
Aug 7, 2026
StartEst.
Aug 15, 2026
Primary completionEst.
Apr 30, 2027
CompletionEst.
Aug 15, 2027
Last update
Aug 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07752784
Lead sponsor
JYAMS PET Research & Development Limited
Responsible party
Sponsor
First posted
Aug 7, 2026
Start date
Aug 15, 2026 (estimated)
Primary completion
Apr 30, 2027 (estimated)
Completion
Aug 15, 2027 (estimated)
Last update
Aug 17, 2026

Study contacts

Qian Tang
Contact
tangqian@pet-tracer.com.cn
025-86166196
Heng He
Contact
heheng@pet-tracer.com.cn
025-86166196

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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