Tau Tracer Comparison in Healthy Controls and Alzheimer's Disease Patients

Inclusion Criteria

• •Male and female subjects 50 to 100 years of age
• •Female subjects must be either surgically sterile or post-menopausal for at least 1 year or,
• •Women of child bearing potential must commit to use a barrier contraception method for the duration of the study in addition to either an intra uterine device or hormonal contraception started at least 1 month prior to the first dose of radiotracer and until follow-up.
• •Male subjects and their partners of childbearing potential must agree to use an effective method of contraception and will not donate sperm during the study. Barrier method must include use of a spermicide.
• •Subjects who sign an IRB approved informed consent prior to any study procedures. Subjects deemed incapable of informed consent must provide assent and informed consent provided by, a legally authorized representative.
• •Subjects who in the opinion of the investigator based on medical history and physical exam can tolerate the PET scan procedures.
• •If subjects are on any concomitant medication, the indication and dosage of these medicines should be stable for at least 4 weeks prior to study start with the expectation that no relevant changes in use or dose will occur throughout the trial.
• •Body mass index BMI between 18 and 32 kg per m2, Body weight less than 300 pounds.
• •Normal cognitive function, including a normal Mini-Mental State Exam (MMSE) (\>28) score as judged by the investigator for Control Subjects.
• •Capacity for consent will be determined using the Alzheimer's Association Guidelines, developed at Johns Hopkins and described in Alzheimer's Association Consensus Recommendation Research consent for cognitively impaired adults Guidelines for Institutional Review Boards and Investigators Alzheimer's Association 2004.
• •Have a reliable study partner able to accompany the subject to all visits and answer questions about the subject.
• •Have a diagnosis of probable AD, according to the National Institute of Neurological and Communicative Disorders and Stroke Alzheimer's Disease and Related Disorders Association criteria
• •MMSE score of between 16 and 26, inclusive.
• •In the opinion of the investigator based on medical history and physical examination, can safely tolerate tracer administration and the scanning procedures.
• •A positive visual read as per local procedures for florbetapir or similar procedures for other amyloid tracers of an amyloid PET scan, or amyloid-beta and tau cerebrospinal fluid (CSF) levels, which in the opinion of the principal investigator is consistent with a diagnosis of AD.