Phase 1 Test-retest Evaluation of [18F]MNI-958 PET

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Brief Title

Phase 1 Test-retest Evaluation of [18F]MNI-958 PET

Official Title

Phase 1 Test-retest Evaluation of [18F]MNI-958 PET as an Imaging Marker for Tau Protein in the Brain of Patients With Alzheimer's Disease and Probable PSP as Compared to Healthy Volunteers

Brief Summary

      The overall goal of this protocol is to evaluate [18F]MNI-958 also known as APN-0000455 or
      PM-PBB3, a tau targeted radiopharmaceutical.
    

Detailed Description

      The overall goal of this protocol is to evaluate [18F]MNI-958 also known as APN-0000455 or
      PM-PBB3, a tau targeted radiopharmaceutical. The specific objectives are:

        -  To measure the dynamic uptake and washout of [18F]MNI- 958 in brain using positron
           emission tomography (PET) in patients with Alzheimer's disease, Progressive Supranuclear
           Palsy and healthy volunteers.

        -  To measure blood metabolites of [18F]MNI-958 and perform kinetic modeling to assess its
           ability to measure tau protein in brain using the tracer plasma concentration or a
           reference region as indirect input.

        -  To obtain test/retest reliability of the tracer binding parameters in patients with
           Alzheimer's disease, Progressive Supranuclear Palsy and healthy volunteers.

        -  To acquire safety data following injection of [18F]MNI-958.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Tracer uptake will be evaluated in regions of interest for analysis of regional [18F]MNI-958 binding/uptake and expressed in SUV by using established methods for normalization for 4 AD, 7 PSP, and 3 HV subjects.


Condition

Healthy Volunteers

Intervention

[18F]MNI-958

Study Arms / Comparison Groups

 [18F]MNI-958
Description:  To measure blood metabolites of [18F]MNI-958 and perform kinetic modeling to assess its ability to measure tau protein in brain using the tracer plasma concentration or a reference region as indirect input.

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

16

Start Date

March 12, 2018

Completion Date

February 6, 2020

Primary Completion Date

February 6, 2020

Eligibility 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 or, if they are of childbearing
             potential, must commit to use a barrier contraception method for the duration of the
             study.

          -  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 for male subjects for
             the study duration.

          -  Male subjects must not donate sperm for the study duration.

          -  Willing and able to cooperate with study procedures

        Inclusion criteria for healthy volunteer subjects

          -  Males and females aged ≥50 years. Healthy with no clinically relevant finding on
             physical examination at screening and upon reporting for the [18F]MNI-958 imaging
             visit.

          -  No cognitive impairment from neuropsychological battery as judged by the investigator

          -  Have screening or prior (in the last 90 days) amyloid PET imaging demonstrating no
             significant amyloid binding based on qualitative (visual read).

          -  No family history of Alzheimer's disease or neurological disease associated with
             dementia

          -  Have a CDR global score=0

          -  Have an MMSE score ≥28

          -  Willing and able to cooperate with study procedures

        Inclusion criteria for subjects with a diagnosis of probable

        Alzheimer's disease (AD):

          -  Males and females aged 50 to 80 years.

          -  Have probable Alzheimer's disease dementia, based on the NINCDS/ADRDA and DSM-IV
             criteria, with mild severity and amnestic presentation

          -  Have a CDR score ≥ 0.5 at screening

          -  Have a MMSE score between ≤ 28.

          -  Have screening or prior (in the last 12 months) amyloid PET imaging demonstrating
             amyloid binding based on qualitative analysis (visual read). Amyloid PET imaging
             results will be shared with participants, and scans may be used by participants for
             future research use.

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

          -  Medications taken for symptomatic treatment of AD must be maintained on a stable
             dosage regimen for at least 30 days before screening visit.

          -  The subject has an appropriate caregiver capable of accompanying subject on all
             visits.

          -  Signed and dated written informed consent obtained from the subject and the subject's
             legally authorized representative or caregiver (if applicable).

        Inclusion criteria for subjects with a diagnosis of Progressive Supranuclear Palsy (PSP)

          -  Males and females aged 50 to 90 years.

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

          -  Have screening or prior DaTscan SPECT imaging demonstrating evidence of dopamine
             transporter deficit based on visual read.

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

          -  Medications taken for symptomatic treatment of PSP must be maintained on a stable
             dosage regimen for at least 30 days before screening visit.

          -  The subject has an appropriate caregiver capable of accompanying subject, if
             necessary.

          -  Signed and dated written informed consent obtained from the subject and the subject's
             legally authorized representative or caregiver (if applicable).

        Exclusion Criteria:

          -  Exclusion Criteria (for All subjects)

               -  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.

               -  Subject 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.

               -  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 FLAIR sequence that is ≥20 mm in
                  any dimension), infectious disease, space-occupying lesions, normal pressure
                  hydrocephalus or any other abnormalities associated with CNS 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.

        Exclusion criteria for subjects with AD:

        • Has received treatment that targeted Aβ or tau within the last 3 months.

        Exclusion criteria for subjects PSP:

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

          -  Subjects may take stable doses of bupropion, however this medication must be held for
             at least 12 hours prior to DaTscan imaging.
      

Gender

All

Ages

18 Years - 55 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

David Russell, M.D., Ph. D, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03545789

Organization ID

[18F]MNI-958 Test-Retest


Responsible Party

Sponsor

Study Sponsor

Invicro


Study Sponsor

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


Verification Date

February 2020