[18F]APN-1607 PET in Subjects With AD Compared to HC

September 1, 2025 updated by: APRINOIA Therapeutics

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
230

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Inclusion Criteria for All Subjects:

  • 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.

Inclusion Criteria for Healthy Subjects:

  • 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.
  • 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).

Inclusion Criteria for Subjects with MCI:

  • 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.

Inclusion Criteria for Subjects with AD:

  • 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.

Exclusion Criteria:

Exclusion Criteria for All Subjects:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Alzheimer's Disease
AD subjects will undergo PET imaging using [18F]APN-1607.
Drug: [18F]APN-1607
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.
Experimental: Mild Cognitive Impairment Due to Alzheimer's Disease
MCI subjects will undergo PET imaging using [18F]APN-1607.
Drug: [18F]APN-1607
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.
Experimental: Healthy Volunteers
Healthy control subjects will undergo PET imaging using [18F]APN-1607.
Drug: [18F]APN-1607
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
15 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety and Tolerability Profile Measured by Adverse Events (AEs)
Time Frame: 15 months
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).
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
APRINOIA Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 21, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 25, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 25, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • APN-1607-301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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