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Evaluation of [18F]APN-1607 PET Uptake in Alzheimer's Disease Patients Compared With Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04141150
Recruitment Status : Recruiting
First Posted : October 28, 2019
Last Update Posted : October 28, 2019
Sponsor:
Information provided by (Responsible Party):
Aprinoia Therapeutics Inc.

Tracking Information
First Submitted Date  ICMJE October 17, 2019
First Posted Date  ICMJE October 28, 2019
Last Update Posted Date October 28, 2019
Actual Study Start Date  ICMJE August 19, 2019
Estimated Primary Completion Date June 19, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 24, 2019)
Assessment of [18F]APN-1607 Uptake Patterns by Regional SUVR Values [ Time Frame: 22 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. Mean and standard deviation of [18F]APN-1607 uptake (ie, SUVR) will be calculated across healthy, MDAD and AD dementia cohorts. Differences between groups will be tested at a P-value of 0.05 using statistical analyses methods (eg, unpaired t-test, ANOVA).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2019)
Safety and Tolerability Profile Measured by Adverse Events (AEs) [ Time Frame: 22 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of [18F]APN-1607 PET Uptake in Alzheimer's Disease Patients Compared With Healthy Subjects
Official Title  ICMJE A Phase 2, Multicenter Study of [18F]APN-1607 Positron Emission Tomography in Subjects With Alzheimer's Disease Compared to Healthy Subjects
Brief Summary The overall objective of this study is to compare the overall pattern of [18F]APN-1607 uptake in subjects with MDAD, subjects with AD dementia, and healthy subjects.
Detailed Description

The overall objective of this study is to compare the overall pattern of [18F]APN-1607 uptake in subjects with MDAD, subjects with AD dementia, and healthy subjects.

The specific objectives are:

  • 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 determine the Braak stage equivalent reflected by [18F]APN-1607 uptake patterns.
  • To evaluate the relationship between regional measures of [18F]APN-1607 uptake and demographic characteristics, eg, age and gender; biological characteristics, eg, apolipoprotein E epsilon 4 (APOE4) carrier status and measures of Aβ burden; and clinical characteristics, eg, 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Alzheimer's Disease
  • Mild Cognitive Impairment Due to Alzheimer's Disease
  • Healthy Volunteers
Intervention  ICMJE 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 7 mCi IV as a bolus injection. [18F]APN-1607 injection will be followed by a 10 ml saline flush.
Study Arms  ICMJE Experimental: [18F]APN-1607
Subjects will undergo PET imaging using [18F]APN-1607.
Intervention: Drug: [18F]APN-1607
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 24, 2019)
130
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 19, 2021
Estimated Primary Completion Date June 19, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Inclusion Criteria for All Subjects:

  • Male or female aged 50 to 85 years, inclusive.
  • 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:

  • Written informed consent must be obtained before any assessment is performed.
  • 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).
  • Has a clinical dementia rating (CDR) score of 0.
  • Has a MMSE score ≥ 27.
  • The subject has an appropriate informant who agrees to accompany the subject to screening to provide information for the CDR. In the event that the informant cannot accompany the subject to screening, the interview may be performed via phone, at the discretion of the site Investigator.

Inclusion Criteria for Subjects with MDAD:

  • 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 CDR score = 0.5.
  • Has an MMSE score between 24 and 30, inclusive.
  • Has a positive screening amyloid PET scan.
  • Medications taken for symptomatic treatment of AD must have been stable for 30 days prior to screening and through completion of the neuropsychological battery.
  • The subject has an appropriate informant to accompany subject for CDR testing and any visits, if required for subject or staff comfort or safety.

Inclusion Criteria for Subjects with AD Dementia:

  • Written informed consent must be obtained before any assessment is performed. If in the Investigator's opinion the patient lacks capacity to consent, participation is only possible if the subject has a legally authorized representative (LAR) or responsible next of kin and that individual provides written informed consent in accordance with the local regulations and guidelines and the guidelines of the independent ethics committee (IEC) or institutional review board (IRB). When written informed consent is provided by a LAR or responsible next of kin, the patient's assent must also be obtained and documented.
  • 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 between 10 and 26, inclusive.
  • Medications taken for symptomatic treatment of AD must have been stable for 30 days prior to screening and through completion of the neuropsychological battery.
  • Has a positive screening amyloid PET scan.
  • Medications taken for symptomatic treatment of AD must have been stable for 30 days prior to screening and through completion of the neuropsychological battery.
  • The subject has an appropriate informant to accompany subject for CDR testing and any visits, if required for subject or staff comfort or safety.

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.
  • 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), has received a non-vaccine investigational treatment for AD or other cause of dementia within the last 3 months (or 5 half-lives of the drug, whichever is longer), or received a passive vaccine for the treatment of AD or other cause of dementia within the last 6 months, or has ever received an active vaccine for the treatment of AD or other cause of dementia.
  • 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 in the US.
  • Pregnant, lactating or breastfeeding.
  • Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency, pulmonary, or other disorder or disease.
  • Unsuitable veins for repeated venipuncture
  • MRI exclusion criteria include: Findings that may be responsible for the neurologic status of the patient such as significant evidence of cerebrovascular disease (more than two lacunar infarcts, any territorial infarct >1cm3, or deep white matter abnormality corresponding to an overall Fazekas scale of 3 with at least one confluent hyperintense lesion on the fluid-attenuated inversion recovery (FLAIR) sequence that is ≥20 mm in any dimension), infectious disease, space-occupying lesions, normal pressure hydrocephalus or any other abnormalities associated with central nervous system (CNS) disease. For subjects with MDAD or AD dementia, there may be evidence of atrophy compatible with AD.
  • 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.

Exclusion Criteria for Healthy Subjects:

  • Meets criteria for a diagnosis of MDAD or dementia or has ever had either diagnosis.
  • Has ever received treatment with a drug for cognitive impairment or dementia.

Exclusion Criteria for Subjects with MDAD:

• Meets criteria for a diagnosis of dementia due to AD.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Te-Yu Chen 886-2-2655-8868 tychen@aprinoia.com
Contact: Pou-Jou Chen 886-2-2655-8868 ext 886226558868 pjchen@aprinoia.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04141150
Other Study ID Numbers  ICMJE APN-1607-201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Aprinoia Therapeutics Inc.
Study Sponsor  ICMJE Aprinoia Therapeutics Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Russell, M.D., Ph.D Invicro
PRS Account Aprinoia Therapeutics Inc.
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP