Evaluation of [18F]MNI-777 PET as a Marker of Tau Pathology in Subjects With Tauopathies Compared to Healthy Subjects

Brief Title

Evaluation of [18F]MNI-777 PET as a Marker of Tau Pathology in Subjects With Tauopathies Compared to Healthy Subjects

Official Title

Evaluation of [18F]MNI-777 PET as a Marker of Tau Pathology in Subjects With Clinically Diagnosed Tauopathies in Comparison to Healthy Subjects

Brief Summary

      The goal of this study is to assess [18F]MNI-777 PET imaging as a tool to detect tau
      pathology in the brain of individuals who carry a clinical diagnosis of a tauopathy,
      including: Alzheimer's Disease (AD),Parkinson's disease (PD) Progressive Supranuclear Palsy
      (PSP), chronic traumatic encephalopathy (CTE) and Frontal Temporal Dementia (FTD) and age-
      and gender-matched healthy subjects.
    

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Brain uptake of [18F]T807 ([18F]MNI-777)

Condition

Alzheimer's Disease (AD)

Intervention

[18F]T807 ([18F]MNI-777)

Study Arms / Comparison Groups

 [18F]T807 ([18F]MNI-777)

Description:  At the [18F]MNI-777 PET imaging visit, subjects will be injected with no more than 10 mCi (370 MBq) of [18F]MNI-777).

Publications

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

Recruitment Status

Drug

Estimated Enrollment

16

Start Date

February 2014

Completion Date

September 2016

Primary Completion Date

August 2016

Eligibility Criteria

        Inclusion Criteria:

        For all subjects:

          -  Written informed consent or assent is obtained.

          -  Willing and able to cooperate with study procedures.

          -  For females, non-child bearing potential or negative urine pregnancy test on day of
             [18F]MNI-777 injection.

        Alzheimer Disease subjects:

          -  The participant is 50 years or older.

          -  Participants have a clinical diagnosis of Alzheimer's disease based on National
             Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease
             and Related Disorders Association (NINCDS/ADRDA) criteria (McKann, 1984)

          -  Modified Hachinski Ischemia Scale score of ≤ 4.

        Parkinson's Disease subjects:

          -  The participant is 30 years or older.

          -  Participants have a clinical diagnosis of PD based on the UK Brain Bank Criteria
             (Hughes, et al., 1982).

          -  The duration of diagnosis of PD is <20 years prior to the imaging visit

          -  PD subjects must be on stable doses of medications for a period of at least 30 days
             prior to the imaging visit.

          -  Treatment with dopamine replacement therapies or other symptomatic therapies for PD is
             permitted; however, subjects must be on a stable dose of medications 30 days prior to
             the imaging visit.

        Progressive Supranuclear Palsy subjects:

          -  The participant is 30 years or older.

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

        Chronic Traumatic Encephalopathy subjects:

          -  The participant is 18 years or older.

          -  Subjects with a diagnosis of probable CTE based on a prior history of repetitive brain
             trauma and at least one concussion, and a current mood disorder (depression, apathy,
             irritability, suicidal ideation), cognitive symptoms (memory loss, impaired executive
             function) or behavioral symptoms (disinhibition, aggression and increased violence)
             (Jordan, 2013).

        Frontal Temporal Dementia/Pick's disease subjects:

          -  The participant is 50 years or older.

          -  Participants have a clinical diagnosis of FTD based on consensus for clinical
             diagnosis of frontotemporal dementia (Neary, et al., 1998)

        Healthy Control subjects:

          -  The participant is 18 - 85 years old.

          -  Negative history of neurological or psychiatric illness based on evaluation by a
             research physician.

          -  MMSE score must be 29 or above.

        Exclusion Criteria:

        All subjects will be excluded from participation for the following reasons:

          -  The subject has a clinically significant abnormal laboratory value and/or clinically
             significant unstable medical or psychiatric illness.

          -  The subject has any disorder that may interfere with drug absorption distribution,
             metabolism, or excretion (including gastrointestinal surgery).

          -  The subject has evidence of a structural lesion on MRI that may interfere with
             interpretation of PET imaging.

          -  The subject has evidence of clinically significant gastrointestinal, cardiovascular,
             hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency,
             pulmonary, or other disorder or disease.

          -  The subject has participated in another clinical study within the previous 30 days.

          -  Pregnancy or women who are nursing or breastfeeding
      

Gender

All

Ages

18 Years - 85 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Danna Jennings, MD, , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT02103894

Organization ID

MNI-777

Responsible Party

Principal Investigator

Study Sponsor

Molecular NeuroImaging

Collaborators

 Institute for Neurodegenerative Disorders

Study Sponsor

Danna Jennings, MD, Principal Investigator, Institute for Neurodegenerative Disorders

Verification Date

December 2016