Clinical Evaluation of Florbetapir F 18 (18F-AV-45)
Condition: Alzheimer Disease; Mild Cognitive Impairment; Neurodegenerative Diseases
MeSH terms: Alzheimer Disease; Neurodegenerative Diseases; Cognitive Dysfunction
Intervention: Florbetapir F 18
Intervention description: 370 MBq (10 mCi)
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1768.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Male or female subjects at least 18 years of age; AD; MCI

Summary:

      This protocol is designed to standardize imaging studies using florbetapir F 18 PET to
      provide information on amyloid burden in subjects participating in other studies (companion
      protocol) such as longitudinal studies of aging and studies of biomarkers for
      neurodegenerative diseases.
    

Eligibility criteria:

        Subjects who meet all of the following criteria are eligible to enroll in this study:

          1. Male or female subjects at least 18 years of age;

          2. Subjects who sign an IRB approved informed consent prior to any study procedures.
             Where subjects are deemed incapable of informed consent, a legally authorized
             representative may provide consent, with the subject's documented assent; and

          3. Subjects who in the opinion of the investigator can tolerate the PET scan procedures.

        Subjects will be excluded from enrollment if they:

          1. Have clinically significant hepatic, renal, pulmonary, metabolic, or endocrine
             disturbances as indicated by history, which in the opinion of the investigator might
             pose a potential safety risk to the subject;

          2. Have current clinically significant cardiovascular disease. Clinically significant
             cardiovascular disease usually includes one or more of the following:

               -  cardiac surgery or myocardial infarction within the last 4 weeks;

               -  unstable angina;

               -  acute decompensated congestive heart failure or class IV heart failure;

               -  current significant cardiac arrhythmia or conduction disturbance, particularly
                  those resulting in ventricular fibrillation, or causing syncope, or near syncope;

               -  uncontrolled high blood pressure; or

               -  QTc > 450 msec (by history or for patients with cardiac disease by screening
                  evaluation in companion study)

             Before enrolling a patient with any of the above conditions, the investigator must
             have performed a cardiac evaluation and obtain permission from the sponsor.

          3. Have a history of drug or alcohol abuse within the last year, or prior prolonged
             history of abuse;

          4. Women of childbearing potential who are not surgically sterile, not refraining from
             sexual activity or not using reliable methods of contraception. Women of childbearing
             potential must not be pregnant (negative urine beta-hCG at the time of screening and
             negative urine beta-hCG on the day of imaging) or breastfeeding at screening. Women
             must avoid becoming pregnant, and must agree to refrain from sexual activity or to use
             reliable contraceptive methods for 24 hours following administration of Florbetapir F
             18 Injection ( such as oral contraceptives for at least three months or an IUD for at
             least two months prior to the start of the screening visit, or various barrier
             methods, e.g., diaphragm or combination condom and spermicide);

          5. Have a history of relevant severe drug allergy or hypersensitivity (Relevant severe
             drug allergies should be determined by the PI, and any questions about a subject's
             eligibility can be directed to Avid. If a subject has a history of severe drug
             allergies, it may be dangerous for them to participate in a study);

          6. Are patients who have received an investigational medication under an FDA IND protocol
             within the last 30 days. Additionally, the time between the last dose of the previous
             experimental medication and enrollment (completion of screening assessments) must be
             at least equal to 5 times the terminal half-life of the previous experimental
             medication. Patients who have ever participated in an experimental study with an
             amyloid targeting therapy (e.g., immunotherapy, secretase inhibitor) may not be
             enrolled without prior sponsor approval unless it can be demonstrated that the patient
             received only placebo in the course of the trial;

          7. Are patients with current clinically significant unstable medical comorbidities, as
             indicated by history or physical exam, that pose a potential safety risk to the
             subject.

          8. Are patients who have received a radiopharmaceutical for imaging or therapy within the
             past 24 hours prior to the imaging session for this study. If another radiotracer is
             required in the companion protocol, patients may be able to receive a
             radiopharmaceutical for imaging or therapy within the 24 hours prior to the imaging
             session with prior sponsor approval and at the discretion of the investigator.; and

          9. Are patients who, in the opinion of the investigator, are otherwise unsuitable for a
             study of this type.

        If at the time of enrollment subjects do not meet all eligibility criteria, the subjects
        may still be enrolled if documentation is provided demonstrating that the subject will meet
        all criteria at the time of the first imaging procedure.