Phase III Study of the Correlation Between Florbetapir F18 PET Imaging and Amyloid Pathology in the Brain
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease; Amyloidosis
Intervention: florbetapir F 18
Intervention description: Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 226.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: florbetapir F 18 PET; amyloid imaging; Amyloid pathology in the brain

Summary:

      The study is designed to test the relationship between measurements of brain amyloid using
      florbetapir F 18 PET imaging and true levels of amyloid by dissection of the brain at
      autopsy. Amyloid in the brain is a key feature of Alzheimer's Disease (AD).
    

Eligibility criteria:

        Inclusion Criteria (autopsy cohort):

          -  Have a projected life expectancy of ≤ 6 months as determined by the principal
             investigator (e.g. terminal medical condition) or are already enrolled in a
             longitudinal study of aging with an autopsy component;

          -  Can tolerate a 10 minute PET scan; and

          -  Give informed consent for study procedures and brain donation consistent with the
             legal requirements of the State in which they are enrolled and the State in which they
             die.

        Inclusion Criteria (specificity cohort):

          -  Cognitively and neurologically healthy males and females 18 to 40 years of age;

          -  Who had no known risk factors for AD, including:

          -  Known genetic risk factors for AD, including an ApoE ε4 allele (note: ApoE genotype
             was determined after enrollment and was not disclosed to healthy control subjects).
             Scans from subjects carrying an ApoE ε4 allele were not included in the primary
             specificity analysis, but were included in an exploratory analysis;

          -  First degree relative with a known progressive dementing disorder;

          -  History of cognitive decline;

          -  History of neurologic, neurodegenerative, or psychiatric disease;

          -  History of head trauma; or

          -  Evidence of brain abnormality on a MRI scan;

          -  Who performed in an age-appropriate normal range on the Wechsler Logical Memory I &
             II, story A;

          -  Who could tolerate a 10-minute PET scan; and

          -  Who provided informed consent before any study procedures were performed.

        Exclusion Criteria:

          -  Have primary brain tumor, known metastases to the brain, central nervous system (CNS)
             lymphoma;

          -  Have any major, focal structural loss of brain matter;

          -  Are aggressively being treated with life sustaining measures (e.g. currently on
             respirator; receiving high dose chemotherapy);

          -  Have a clinically significant infectious disease, including Acquired Immune Deficiency
             Syndrome (AIDS), Human Immunodeficiency Virus (HIV) infection, previous positive test
             for hepatitis or HIV or Creutzfeldt-Jakob disease (CJD);

          -  Are receiving any investigational medications, or have participated in a trial with
             investigational medications within the last 30 days;

          -  Have ever participated in an experimental study with an amyloid targeting agent (e.g.
             anti-amyloid immunotherapy, secretase inhibitor);

          -  Have had a radiopharmaceutical imaging or treatment procedure within 7 days prior to
             the study imaging session; or

          -  Are females of childbearing potential who are pregnant or not using adequate
             contraception.