Alzheimer's DiseasePhase 3NCT05542953
[18F]APN-1607 PET in Subjects With AD Compared to HC
A Phase 3 study testing [18F]APN-1607 in people with Alzheimer's Disease and Mild Cognitive Impairment Due to Alzheimer's Disease, run by APRINOIA Therapeutics at 1 site in China.
Trial summary
The overall objective of this study is to compare the overall pattern of [18F]APN-1607 uptake in subjects with MCI, subjects with AD dementia, and healthy subjects. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, Mild Cognitive Impairment Due to Alzheimer's Disease, Healthy Volunteers
- 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
- 230 participants
- Where
- 1 siteChina
- Study dates
- 21 Jan 2022to 25 Dec 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent must be obtained before any assessment is performed.
- Female subjects must be documented by medical records or physician's note to be either surgically sterile (by means of hysterectomy, bilateral oophorectomy, or tubal ligation) or post-menopausal for at least 1 year (ie, 12 consecutive months with no menses without an alternative medical cause) or, if they are of childbearing potential, must commit to use a barrier contraception method or to abstinence for the duration of the study and must have negative serum and urine pregnancy tests.
- Male subjects and their partners of childbearing potential must commit to the use of two methods of contraception, one of which is a barrier method (ie, condom), or to abstinence for the study duration.
- Male subjects must not donate sperm for the study duration.
- Willing and able to participate in all study procedures.
- Medically healthy with no clinically relevant finding on physical examination, laboratory profiles, VS, or ECG at screening and upon reporting for the [18F]APN-1607 Imaging Visit.
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- No cognitive impairment based on neuropsychological battery and as judged by the Investigator.
- No first-degree family history of early-onset AD or other neurological disease associated with dementia (prior to age 65).
- Written informed consent must be obtained before any assessment is performed.
- Must meet all of the clinical criteria for MCI according to NIA-AA criteria, including lack of functional impairment sufficient to warrant a diagnosis of dementia.
- Has a diagnosis of AD dementia according to NIA-AA criteria, including significant impairment of activities of daily living.
- Medications taken for symptomatic treatment of AD must have been stable for 30 days prior to screening and through completion of the neuropsychological battery.
Who cannot join
- Current or prior history (within the last 10 years) of alcohol or drug abuse.
- Known hypersensitivity to [18F]APN-1607 or its excipients.
- Clinically significant active or unstable medical illness or planned surgical procedures during the study period. History of cancer (other than nonmelanoma skin cancers or stable, local prostate cancer), unless without evidence of active disease within the last 3 years and without ongoing medical or surgical therapy.
- Laboratory tests with clinically significant abnormalities or a history or evidence of clinically significant unstable medical illness.
- Prior participation in other research protocols or clinical care in the last year in addition to the radiation exposure expected from participation in this clinical study, such that radiation exposure exceeds local guidelines.
- Pregnant, lactating or breastfeeding.
- Unsuitable veins for repeated venipuncture.
- Implants, or history of claustrophobia in MRI.
Trial locations and contacts
1 site in 1 country.
China1 site
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430000
About this study
Official title: A Phase 3, Multicenter Study of [18F]APN-1607 Positron Emission Tomography in Subjects With Alzheimer's Disease Compared to Healthy Subjects
The overall objective of this study is to compare the overall pattern of [18F]APN-1607 uptake in subjects with MCI, subjects with AD dementia, and healthy subjects.
- Conditions
- Alzheimer's Disease, Mild Cognitive Impairment Due to Alzheimer's Disease, Healthy Volunteers
- Being tested
- [18F]APN-1607
- Keywords
- AD, MCI, HV, 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
In this study, all patients will receive one injection of [18F]APN-1607, a PET radiopharmaceutical selective for fibrillar tau. For the injection, subjects will receive a target dose of 5-7 mCi IV as a bolus injection. [18F]APN-1607 injection will be followed by a 10 ml saline flush.
| 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 | Experimental | 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.
Assessment of [18F]APN-1607 Uptake Patterns by Regional SUVR Values
Regional [18F]APN-1607 uptake patterns will be assessed in regions of interest (ROIs) and an iROI that are relevant to AD pathology. [18F]APN-1607 uptake patterns identified by regional analysis will be compared among healthy subjects, subjects with MDAD, and subjects with AD dementia. Standard uptake value (SUV) will be calculated for each ROI, and SUVRs will be calculated by normalizing SUV of ROIs to the SUV of relevant reference region.
Measured: 15 months
Secondary outcomes (1)
Safety and Tolerability Profile Measured by Adverse Events (AEs)
Safety and tolerability profile for the administration of [18F]APN-1607 and positron emission tomography (PET) scanning are measured by number of participants with adverse events (AEs).
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 posted16 Sep 2022
- Study start21 Jan 2022
- Primary completion25 Dec 2023
- Study completion25 Dec 2023
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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- APRINOIA Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05542953
- Sponsor's protocol ID
- APN-1607-301
- Status last verified
- Sep 2025
- First submitted
- 24 Jan 2022
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter Study of [18F]APN-1607 Positron Emission Tomography in Subjects With Alzheimer's Disease Compared to Healthy Subjects
- ClinicalTrials.gov ID
- NCT05542953
- Acronym / sponsor ID
- APN-1607-301
- Conditions
- Alzheimer's Disease, Mild Cognitive Impairment Due to Alzheimer's Disease, Healthy Volunteers
- Keywords
- AD, MCI, HV, APN-1607
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- APRINOIA TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- 25 Dec 2023 (actual)
- Study completion
- 25 Dec 2023 (actual)
- First posted
- 16 Sep 2022 (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.
The overall objective of this study is to compare the overall pattern of [18F]APN-1607 uptake in subjects with MCI, subjects with AD dementia, and healthy subjects.
Study design
- Primary purpose
- Other
- 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 | Experimental | Drug: [18F]APN-1607Healthy control subjects will undergo PET imaging using [18F]APN-1607. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Written informed consent must be obtained before any assessment is performed.
- Female subjects must be documented by medical records or physician's note to be either surgically sterile (by means of hysterectomy, bilateral oophorectomy, or tubal ligation) or post-menopausal for at least 1 year (ie, 12 consecutive months with no menses without an alternative medical cause) or, if they are of childbearing potential, must commit to use a barrier contraception method or to abstinence for the duration of the study and must have negative serum and urine pregnancy tests.
- Male subjects and their partners of childbearing potential must commit to the use of two methods of contraception, one of which is a barrier method (ie, condom), or to abstinence for the study duration.
- Male subjects must not donate sperm for the study duration.
- Willing and able to participate in all study procedures.
Key exclusion criteria (8 listed)
- Current or prior history (within the last 10 years) of alcohol or drug abuse.
- Known hypersensitivity to [18F]APN-1607 or its excipients.
- Clinically significant active or unstable medical illness or planned surgical procedures during the study period. History of cancer (other than nonmelanoma skin cancers or stable, local prostate cancer), unless without evidence of active disease within the last 3 years and without ongoing medical or surgical therapy.
- Laboratory tests with clinically significant abnormalities or a history or evidence of clinically significant unstable medical illness.
- Prior participation in other research protocols or clinical care in the last year in addition to the radiation exposure expected from participation in this clinical study, such that radiation exposure exceeds local guidelines.
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-1607In this study, all patients will receive one injection of [18F]APN-1607, a PET radiopharmaceutical selective for fibrillar tau. For the injection, subjects will receive a target dose of 5-7 mCi IV as a bolus injection. [18F]APN-1607 injection will be followed by a 10 ml saline flush. | Drug | Alzheimer's Disease, Healthy Volunteers, Mild Cognitive Impairment Due to Alzheimer's Disease |
Primary outcome
Assessment of [18F]APN-1607 Uptake Patterns by Regional SUVR Values
Time frame: 15 months
Regional [18F]APN-1607 uptake patterns will be assessed in regions of interest (ROIs) and an iROI that are relevant to AD pathology. [18F]APN-1607 uptake patterns identified by regional analysis will be compared among healthy subjects, subjects with MDAD, and subjects with AD dementia. Standard uptake value (SUV) will be calculated for each ROI, and SUVRs will be calculated by normalizing SUV of ROIs to the SUV of relevant reference region.
1 secondary outcome
Safety and Tolerability Profile Measured by Adverse Events (AEs)
Time frame: 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 and Mild Cognitive Impairment Due to Alzheimer's Disease, run by APRINOIA Therapeutics 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 12 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: finished, as of the sponsor's last update on 8 Sep 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of [18F]APN-1607 Uptake Patterns by Regional SUVR Values (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 8 Sep 2025.