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

September 13, 2022 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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

230

Phase

  • 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
        • Recruiting
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
        • Contact:

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

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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
Intervention / Treatment
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

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

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

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)

February 11, 2022

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

January 24, 2022

First Submitted That Met QC Criteria

September 13, 2022

First Posted (Actual)

September 16, 2022

Study Record Updates

Last Update Posted (Actual)

September 16, 2022

Last Update Submitted That Met QC Criteria

September 13, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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

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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