Effectiveness of Florbetapir (18F) PET Imaging in Changing Patient Management and the Relationship Between Scan Status and Cognitive Decline
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Intervention: florbetapir (18F)
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 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 641.0
Sex: All
Minimum age: 50 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      This study is designed to determine the effectiveness of florbetapir (18F) in changing
      patient management and to evaluate the association between scan status and cognitive decline.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients may be enrolled in the mild impairment (not demented) group if the following
        criteria are met:

          1. Males or females ≥ 50 to <= 90 years of age.

          2. Have cognitive decline verified by a study partner or cognitive impairment verified by
             the study physician.

          3. Have a study partner who provides separate consent and is willing to accompany the
             patient on all of the study visits.

          4. Have an MMSE score of 24 to 30 inclusive.

          5. Can tolerate a 10-minute PET scan.

          6. Have the ability to cooperate and comply with all study procedures.

          7. Have an enrolling physician who has less than high confidence in their diagnosis for
             the patient related to the cognitive decline at the time of enrollment.

          8. Ability to provide informed consent for study procedures.

        Patients may be enrolled in the dementia group if the following criteria are met:

          1. Are males or females ≥ 50 to <= 90 years of age.

          2. Meet clinical criteria for dementia.

          3. Have a caregiver who provides separate consent and is willing to accompany the patient
             on all of the study visits.

          4. Have an MMSE score of 16 to 24 inclusive.

          5. Have not received a clinical examination and/or laboratory test results that strongly
             indicates a non-neurodegenerative cause for the patients cognitive impairment.

          6. Can tolerate a 10-minute PET scan.

          7. Have the ability to cooperate and comply with all study procedures.

          8. Have an enrolling physician who has less than high confidence in their diagnosis for
             the patient related to the cognitive decline at the time of enrollment.

          9. Ability to provide informed consent for study procedures. (If the patient is incapable
             of giving informed consent, the patient's legal representative may consent on behalf
             of the patient but the patient must still confirm assent. This person may serve as the
             study partner as well).

        Exclusion Criteria:

        Patients will be excluded from enrollment if they:

          1. Have a current serious or unstable illness;

          2. The patient or enrolling physician knows the result of a previous amyloid imaging
             scan;

          3. The patient has a known brain lesion, pathology or alternative diagnosis that strongly
             explains the patient's clinical presentation;

          4. Are receiving any investigational medications, or have participated in a trial with
             investigational medications within the last 30 days;

          5. Have ever participated in an experimental study with an amyloid targeting agent (e.g.
             anti-amyloid immunotherapy, γ -secretase or β -secretase inhibitor) unless it can be
             documented that the patient received only placebo during the course of the trial;

          6. Have had a radiopharmaceutical imaging or treatment procedure within 7 days prior to
             the study imaging session; or

          7. Are females of childbearing potential who are not surgically sterile, not refraining
             from sexual activity or not using reliable methods of contraception.

        Patients will also be excluded from enrollment if their enrolling physician:

          1. Does not consider Alzheimer's disease as a potential cause of the patient's cognitive
             decline.

          2. Is not the primary physician taking care of the patient with respect to the management
             of their cognitive impairment.

          3. Cannot categorize the patient as either: a) having a documented and completed
             evaluation for cognitive decline within the past 18 months old; or b) currently
             undergoing evaluation for cognitive decline.

          4. Is unwilling to suspend all testing and other evaluation procedures between the time
             of the baseline evaluation of the enrolling physician's diagnosis and management plan
             and the time the completion of the PET scan.