Evaluation of [18F]APN-1607 as a PET Biomarker

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Brief Title

Evaluation of [18F]APN-1607 as a PET Biomarker

Official Title

Evaluation of [18F]APN-1607 as a PET Biomarker for Longitudinal Change in Tau Pathology in Participants With Progressive Supranuclear Palsy

Brief Summary

      The overall goal of this protocol is to evaluate [18F]APN-1607 as a PET radiotracer for
      measuring longitudinal change in tau pathology in participants with PSP.
    

Detailed Description

      The overall goal of this protocol is to evaluate [18F]APN-1607 as a PET radiotracer for
      measuring longitudinal change in tau pathology in participants with PSP. The specific
      objectives are:

        -  To characterize and demonstrate the longitudinal progression of tau deposition in vivo
           in participants with PSP.

        -  To determine optimal PET analysis parameters for [18F]APN-1607 quantification.

        -  To characterize the stability of tau deposition in vivo over time in healthy volunteers
           (HVs).

        -  To evaluate consistency of [18F]APN-1607 quantification in characterizing tau
           deposition.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Change in standardized uptake value ratios (SUVRs) of regional [18F]APN-1607.


Condition

Progressive Supranuclear Palsy

Intervention

[18F] APN-1607

Study Arms / Comparison Groups

 [18F]APN-1607
Description:  Participants will receive an IV bolus injection of [18F]APN-1607, followed by PET brain imaging.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

18

Start Date

May 25, 2021

Completion Date

June 1, 2023

Primary Completion Date

June 1, 2022

Eligibility Criteria

        Inclusion Criteria for all participants:

          -  Males or females from 50 to 80 years of age at Screening, inclusive.

          -  Body weight range of ≥ 43 kg to ≤ 120 kg.

          -  Score ≥20 on the MMSE at Screening.

          -  For women of childbearing potential, agreement to remain abstinent (refrain from
             heterosexual intercourse) or use contraception, and agreement to refrain from donating
             eggs, as defined below:

               -  A woman is considered to be of childbearing potential if she is postmenarchal,
                  has not reached a postmenopausal state (12 continuous months of amenorrhea with
                  no identified cause other than menopause), and is not permanently infertile due
                  to surgery (ie, removal of ovaries, fallopian tubes, and/or uterus) or another
                  cause as determined by the Investigator (eg, Müllerian agenesis). The definition
                  of childbearing potential may be adapted for alignment with local guidelines or
                  regulations.

               -  Women of childbearing potential must remain abstinent or use 2 methods of
                  contraception, one of which is a barrier method (ie, male or female condom), for
                  the study duration and 30 days after the last dose.

          -  Male participants with partners of childbearing potential must commit to the use of 2
             methods of contraception, one of which is a barrier method (ie, male condom with or
             without spermicidal jelly), for the study duration and 90 days after the last dose.

          -  Male participants must not donate sperm for the duration of the study and 90 days
             after the last dose.

          -  For participants receiving arterial cannulation, adequate circulation to the hand for
             safe placement of arterial line (as determined by Allen's test) and blood clotting
             (prothrombin time and partial thromboplastin time [PT & PTT]).

        Additional Inclusion Criteria for HVs

          -  Understand the study procedures and agree to participate by providing written informed
             consent.

          -  Healthy with no clinically relevant finding on physical examination at Screening.

          -  No cognitive impairment based on neuropsychological testing, as judged by the
             Investigator.

          -  No family history of neurological disease associated with dementia.

        Additional Inclusion Criteria for Participants with PSP

          -  Agree to participate by providing written informed consent or written assent with
             informed consent from the participant's LAR or caregiver.

          -  Has a clinical diagnosis of probable PSP based on the National Institute of
             Neurological Disorders and Stroke and the Society for PSP (NINDS-SPSP) criteria
             (Litvan, et al 1996).

          -  Have Screening or prior DaTscan SPECT imaging demonstrating evidence of DaT deficit,
             based on visual read.

          -  A brain MRI scan that supports a diagnosis of PSP, with no other evidence of
             significant neurologic pathology.

          -  Deemed by the opinion of the Principal Investigator to be physically able to
             participate in all visits throughout the duration of the trial.

          -  Medications taken for symptomatic treatment of PSP should be maintained on a stable
             dosage regimen for at least 30 days before Screening, if possible.

          -  The participant has an appropriate caregiver capable of accompanying participant, if
             applicable.

        Exclusion Criteria for all participants:

          -  Participants are only eligible if they do not fulfill any of the exclusion criteria
             for the participant group.

               -  Current or prior history (in the last 12 months) of any alcohol or drug abuse.

               -  Laboratory tests with clinically significant abnormalities and/or clinically
                  significant unstable medical illness.

               -  Participants with QT interval corrected for heart rate using Fridericia's formula
                  (QTcF) >450 msec (males) or >470 msec (females) at Screening will be excluded.
                  ECG measurements may be repeated once.

               -  Has received an investigational drug or device within 30 days of Screening.

               -  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 the effective dose of 50
                  mSv, which would be above the acceptable annual limit established by the US
                  Federal Guidelines.

               -  Pregnancy, 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 or contraindication to arterial blood
                  sampling (for participants who will receive arterial blood sampling).

               -  MRI exclusion criteria include: Findings that may be responsible for the
                  neurologic status of the participant such as significant evidence of
                  cerebrovascular disease (more than 2 lacunar infarcts, any territorial infarct >1
                  cm3, 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 (other than
                  findings consistent with PSP for participants with PSP).

               -  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.

               -  Use of over the counter (OTC) medication (except acetaminophen), dietary
                  supplements, or vitamins, within 2 weeks prior to initial dosing, unless approved
                  by the Investigator.

               -  Has a known hypersensitivity to any component of the formulation of [18F]APN-1607
                  or related compounds.

               -  Major surgery, or donation or loss of 400 mL or more of blood within 4 weeks
                  prior to initial dosing, or longer, if required by local regulation.

               -  History of immunodeficiency diseases, including a positive HIV test result.

               -  A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody test
                  result.

               -  Participant is, in the opinion of the Investigator, unsuitable in any other way
                  to participate in this study.

               -  If available, evidence of amyloid deposition on amyloid PET.

               -  Any new or change in prescription drugs prior to initial dosing, unless approved
                  by the Investigator.

        Additional Exclusion Criteria for HVs

        • The participant is currently exposed to nicotine products or had regular nicotine
        exposure within a six-month period, to be verified by urine cotinine screening

        Additional Exclusion Criteria for Participants With PSP

          -  Ongoing treatment with methylphenidate, modafinil, metoclopramide, alpha methyldopa,
             reserpine, or amphetamine derivative, for participants requiring DaTscan imaging.

          -  Participant has known hypersensitivity to iodine or potassium iodide (KI) in the
             opinion of the Investigator.
      

Gender

All

Ages

50 Years - 80 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

David Russell, M.D., Ph.D., 203-401-4300, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT05005819

Organization ID

APN-1607 (9646)


Responsible Party

Sponsor

Study Sponsor

Invicro


Study Sponsor

David Russell, M.D., Ph.D., Principal Investigator, Invicro


Verification Date

August 2021