Potential of Florbetapir F 18 PET to Inform Clinical Diagnosis and Management of Patients With Progressive Cognitive Decline
Condition: Progressive Cognitive Decline
MeSH terms: Cognitive Dysfunction
Intervention: florbetapir F 18
Intervention description: IV injection, 370 megabecquerel (MBq) (10 millicurie [mCi]), single dose
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 239.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      The study is designed to evaluate whether a florbetapir F 18 PET scan can impact clinical
      thinking when physicians are determining the likely cause of a subject's cognitive
      impairment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are one of the following:

               1. Group A: Recently completed (within the past 18 months) a comprehensive clinical
                  evaluation for progressive cognitive decline.

               2. Group B: Currently being evaluated for progressive cognitive decline with further
                  clinical or laboratory testing still planned.

          -  Have a site enrolling physician who has

               1. less than high confidence in their diagnosis for the subject related to the
                  cognitive decline at the time of enrollment. The level of confidence in the
                  diagnosis should be rated by the physician as less than 85%, and should be
                  interpreted as the physician estimating that their diagnosis will be correct in
                  less than 85% of patients with the same presentation as the subject; and

               2. suspicion that the subject's cognitive decline is caused, at least in part, by
                  Alzheimer's disease. The level of suspicion should be rated by the physician as
                  there being at least 15% of patients with the same presentation as the subject
                  would have Alzheimer's disease;

          -  Can tolerate a 10 minute PET scan. The Principal Investigator will carefully assess
             each subject and use sound medical judgment to determine whether the subject can
             tolerate the PET scan procedure;

          -  Have the ability to cooperate and comply with all study procedures;

          -  Have a study partner willing to accompany the subject on all of the study visits; and

          -  Give informed consent for study procedures (If the subject is incapable of giving
             informed consent, the subject's designated decision maker may consent on behalf of the
             subject but the subject must still confirm assent. This person may serve as the study
             partner as well).

        Exclusion Criteria:

          -  Subject or site enrolling physician knows the result of a previous amyloid imaging
             scan.

          -  Are considered medically unstable;

          -  Require additional laboratory tests or workup between enrollment and completion of the
             florbetapir F 18 PET scan;

          -  Have a clinically significant infectious disease, including Acquired Immunodeficiency
             Syndrome (AIDS) or Human Immunodeficiency Virus (HIV) infection;

          -  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 unless
             it can be documented that the subject received only placebo during the course of the
             trial;

          -  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 not surgically sterile, not refraining
             from sexual activity or not using reliable methods of contraception. Females of
             childbearing potential must not be pregnant (negative serum β-hCG at the time of
             screening and negative urine β-hCG on the day of imaging) or breast feeding at
             screening. Females must avoid becoming pregnant, and must agree to refrain from sexual
             activity or to use reliable contraceptive methods such as prescribed birth control or
             intrauterine device (IUD) for 24 hours following administration of florbetapir F 18.