Subjects With Mild Cognitive Impairment (MCI) of AD, Alzheimer's Disease (AD) DementiaPhase 3NCT07422857
Evaluate the Use of [18F]-APN-1607 PET in Subjects With AD-related Cognitive Impairment and Subjects With Normal Cognitive Function
A Phase 3 study testing [18F]-APN-1607 in people with Subjects With Mild Cognitive Impairment (MCI) of AD, Alzheimer's Disease (AD) Dementia, run by JYAMS PET Research & Development Limited at 2 sites in China.
Trial summary
This study is to evaluate the efficacy and safety of [18F]-APN-1607 Injection in PET imaging for detecting AD-related cognitive impairment. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Subjects With Mild Cognitive Impairment (MCI) of AD, Alzheimer's Disease (AD) Dementia
- 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
- 316 participants
- Where
- 2 sitesChina
- Study dates
- 22 Jan 2026to 1 Feb 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
- 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.
Who cannot join
- Specific clinical phenotypes of atypical AD as defined in the 2014 IWG-2 criteria
- 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;
- 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;
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- History of alcohol or drug abuse/dependency;
- Hypersensitivity to the investigational drug or any of its components;
- Currently pregnant or breastfeeding;
- 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;
- 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
- 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
- There are other situations that researchers consider unsuitable for participating in the experiment.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Huashan Hospital of Fudan University
Shanghai, Province, 201199
Jintai Yu, M.D., 021-52889999, jintai_yu@fudan.edu.cn
- Not yet recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430000
About this study
Official title: 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
This study is to evaluate the efficacy and safety of [18F]-APN-1607 Injection in PET imaging for detecting AD-related cognitive impairment.
- Being tested
- [18F]-APN-1607
- Medical subject headings
- Alzheimer Disease, Dementia
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 |
|---|---|---|
| Alzheimer's Disease | Experimental | AD subjects will undergo PET imaging using [18F]APN-1607. Receives: Drug: [18F]-APN-1607 |
| Mild Cognitive Impairment Due to Alzheimer's Disease | Experimental | MCI subjects will undergo PET imaging using [18F]APN-1607. Receives: Drug: [18F]-APN-1607 |
| Healthy Volunteers | Other | Healthy control 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 effectiveness of visual reading results of [18 F]-APN-1607 injection PET imaging in detecting tau NFTs（Neurofibrillary Tangles）
Sensitivity and specificity of PET imaging visual interpretation results of [ 18 F]-APN-1607 injection compared with true standards
Measured: 15 months
Secondary outcomes (2)
Assessment of [18 F]-APN-1607 Uptake Patterns by Regional SUVR Values and the capability in differentiating different groups
Based on [18F]-APN-1607 PET, the sensitivity and specificity of area under the curve (AUC) with semi-quantitative analysis of standardized uptake values (SUVR) of brain regions of comprehensive interest (iROI) in the brain to distinguish HV subjects from AD-related cognitive impairment subjects (MCI+AD), as well as MCI subjects from AD subjects.
Measured: 15 months
Safety and Tolerability Profile Measured by Adverse Events (AEs)
Safety for theadministration of [18F]APN-1607 and PET scanning is measured by number of participants with Adverse events / Serious adverse events
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start22 Jan 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjects With Mild Cognitive Impairment (MCI) of AD, Alzheimer's Disease (AD) DementiaStudies 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
- 316 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
- NCT07422857
- Sponsor's protocol ID
- DCAMS-F10-302
- Status last verified
- Feb 2026
- First submitted
- 29 Jan 2026
- Last updated
- 20 Feb 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 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07422857
- Acronym / sponsor ID
- DCAMS-F10-302
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 316 participants (estimated)
- Lead sponsor
- JYAMS PET Research & Development LimitedIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 20 Feb 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.
This study is to evaluate the efficacy and safety of [18F]-APN-1607 Injection in PET imaging for detecting AD-related cognitive impairment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alzheimer's Disease | Experimental | Drug: [18F]-APN-1607AD subjects will undergo PET imaging using [18F]APN-1607. |
| Mild Cognitive Impairment Due to Alzheimer's Disease | Experimental | Drug: [18F]-APN-1607MCI subjects will undergo PET imaging using [18F]APN-1607. |
| Healthy Volunteers | Other | Drug: [18F]-APN-1607Healthy control 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 (5 listed)
- 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.
Key exclusion criteria (13 listed)
- Specific clinical phenotypes of atypical AD as defined in the 2014 IWG-2 criteria
- 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;
- Brain structural abnormalities confirmed by MRI, such as large strokes (infarct area greater than 4 cm) or intracranial space-occupying lesions;
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, Healthy Volunteers, Mild Cognitive Impairment Due to Alzheimer's Disease |
Primary outcome
Evaluate the effectiveness of visual reading results of [18 F]-APN-1607 injection PET imaging in detecting tau NFTs（Neurofibrillary Tangles）
Time frame: 15 months
Sensitivity and specificity of PET imaging visual interpretation results of [ 18 F]-APN-1607 injection compared with true standards
2 secondary outcomes
Assessment of [18 F]-APN-1607 Uptake Patterns by Regional SUVR Values and the capability in differentiating different groups
Time frame: 15 months
Safety and Tolerability Profile Measured by Adverse Events (AEs)
Time frame: 15 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 20 Feb 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.
2 sites 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 Subjects With Mild Cognitive Impairment (MCI) of AD, Alzheimer's Disease (AD) Dementia, run by JYAMS PET Research & Development Limited at 2 sites 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 5 inclusion and 13 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 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the effectiveness of visual reading results of [18 F]-APN-1607 injection PET imaging in detecting tau NFTs（Neurofibrillary Tangles） (time frame: 15 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 20 Feb 2026.