Tau Imaging in Subjects With Progressive Supranuclear Palsy, Corticobasal Degeneration and Healthy Volunteers
Condition: Progressive Supranuclear Palsy; Corticobasal Degeneration
MeSH terms: Supranuclear Palsy, Progressive; Corticobasal Degeneration
Intervention: Flortaucipir F18; Brain PET scan
Intervention description: IV injection, 370 megabecquerel (MBq) (10 mCi); positron emission tomography (PET) scan of the brain 75-105 minutes post-injection
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate flortaucipir for brain imaging of tau in subjects with progressive
      supranuclear palsy (PSP), corticobasal degeneration (CBD) and healthy volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

        Cognitively Healthy Volunteers

          -  Mini-mental state examination (MMSE) ≥ 28

          -  No history of cognitive decline or parkinsonian motor disorder

        CBD and PSP subjects

          -  Able to walk 10 steps with minimal assistance

          -  MMSE ≥ 14 and ≤ 30

          -  Subject has a reliable study partner who agrees to accompany subject to visits and
             spends at least 5 hours per week with the subject

        PSP subjects only

          -  Meet National Institute of Neurological Disorders and Stroke - Society for Progressive
             Supranuclear Palsy (NINDS-SPSP) probable or possible PSP criteria as modified for the
             Neuroprotection and Natural History Parkinson Plus Syndromes (NNIPPS) clinical trial

        CBD subjects only

          -  Meets 2013 consensus criteria for possible or probable corticobasal degeneration,
             corticobasal syndrome (CBS) subtype

        Exclusion Criteria:

        All subjects

          -  Have evidence of structural abnormalities such as vascular disease, large strokes or
             severe white matter disease or other mass lesion on screening MRI

          -  Claustrophobia

          -  Current clinically significant cardiovascular disease or clinically significant
             abnormalities on screening electrocardiogram (e.g. corrected QT interval >450 msec)

          -  Have a history of risk factors for Torsades de Pointes (e.g. heart failure,
             hypokalemia, family history of long QT syndrome)

          -  Have a current clinically significant infectious disease, endocrine or metabolic
             disease, pulmonary, renal or hepatic impairment, or cancer

          -  Females of childbearing potential who are not surgically sterile, not refraining from
             sexual activity or not using reliable methods of contraception

          -  Have received or participated in a trial with investigational medications in the past
             30 days

          -  Have had a non-study related radiopharmaceutical imaging or treatment procedure within
             7 days prior to the study imaging session

          -  Have a history of neuroleptic use for a prolonged period of time or within the past 6
             months

        PSP and CBD subjects

          -  Have evidence of amyloid deposition

          -  Meet National Institute on Aging-Alzheimer's Association criteria for probable
             Alzheimer's Disease

          -  Have any other neurological condition other than CBS or PSP that could account for
             cognitive or motor deficits

          -  Serum or plasma progranulin level less than one standard deviation below the normal
             subject mean for the laboratory performing the assay

          -  Have a high-risk family history suggestive of tar DNA binding protein (TDP)-43
             pathology or known mutations