Clinical Evaluation of [18F]APN-1607 PET Uptake in Alzheimer's Disease Patients

September 12, 2023 updated by: FengWang, Nanjing First Hospital, Nanjing Medical University

Director of Nuclear Medicine Department

The overall objective of this study is to evaluate the overall pattern of [18F]APN-1607 uptake in subjects with AD dementia

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

  • To expand the safety and tolerability profile for the administration of [18F]APN-1607 and PET scanning.
  • To assess regional patterns of [18F]APN-1607 uptake.
  • To evaluate the relationship between regional measures of [18F]APN-1607 uptake and measurements of AD disease severity, such as National Institute on Aging and Alzheimer's Association (NIA-AA) diagnosis, Mini-mental Status Exam (MMSE) score, and Alzheimer's Disease Assessment Scale-cognitive subscale (ADAScog).

Study Type

Interventional

Enrollment (Estimated)

6

Phase

  • Early Phase 1

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • China
      • Nanjing, China
        • Recruiting
        • Nanjing First Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Feng Wang, Ph.D

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

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female aged 45 to 80 years, inclusive.
  • Has a diagnosis of AD dementia according to NIA-AA criteria, including significant impairment of activities of daily living.
  • Has a CDR score ≥ 0.5 at screening.
  • Has a MMSE score ≤ 25.
  • Brain MRI supports the diagnosis of AD and there is no evidence of other nervous system diseases.
  • Medications taken for symptomatic treatment of AD must have been stable for 30 days prior to screening and through completion of the neuropsychological battery.
  • If necessary, the subject can be accompanied by nursing staff.
  • 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.

Exclusion Criteria:

  • Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency, pulmonary, or other disorder or disease.
  • Implants, such as implanted cardiac pacemakers or defibrillators, insulin pumps, cochlear implants, metallic ocular foreign body, implanted neural stimulators, CNS aneurysm clips and other medical implants that have not been certified for MRI, or history of claustrophobia in MRI.
  • Intolerance to MRI noise or hermetic phobia.
  • 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, eg, above an effective dose of 50 mSv.
  • Current or prior history (within the last 10 years) of alcohol or drug abuse.
  • Pregnant, lactating or breastfeeding.
  • Unsuitable veins for repeated venipuncture
  • Has received any investigational drug or device for any purpose within 30 days of screening (or 5 half-lives of the drug, whichever is longer).
  • Known hypersensitivity to [18F]APN-1607 or its excipients
  • Has received a non-vaccine investigational treatment for Aβ within the last 3 months.
  • Has received a non-vaccine investigational treatment for tau within the last 3 months.
  • Any situation that the presiding officer of this study believes may cause harm or potential harm to any link related to this test.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: [18F]APN-1607
For the injection, subjects will receive a target dose of 0.1~0.15mCi/Kg [18F]APN-1607 as a bolus injection.
Drug: [18F]APN-1607
Subjects will receive one injection of [18F]APN-1607 (0.1~0.15mCi/Kg), a PET radiopharmaceutical selective for fibrillar tau. [18F]APN-1607 injection will be followed by a 10 ml saline flush.
Other Names:
  • [18F]PBB3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of [18F]APN-1607 Uptake Patterns by Regional SUV Values
Time Frame: 36 months
[18F]APN-1607 uptake patterns will be assessed in regions of interest (ROIs) which relevant to AD pathology. Standard uptake value (SUV) will be calculated for each ROI, and standardized uptake value ratios (SUVRs) will be calculated by normalizing SUV of ROIs to the SUV of relevant reference region.
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability Profile Measured by Adverse Events (AEs)
Time Frame: 36 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).
36 months

Collaborators and Investigators

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

Sponsor

Nanjing First Hospital, Nanjing Medical University

Investigators

  • Study Director: Feng Wang, Nanjing First Hospital, Nanjing Medical University

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)

September 10, 2021

Primary Completion (Estimated)

September 10, 2024

Study Completion (Estimated)

September 10, 2024

Study Registration Dates

First Submitted

September 13, 2021

First Submitted That Met QC Criteria

September 13, 2021

First Posted (Actual)

September 14, 2021

Study Record Updates

Last Update Posted (Actual)

September 14, 2023

Last Update Submitted That Met QC Criteria

September 12, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • wf-[18F]APN-1607

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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