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

This is an interventional diagnostic trial for Healthy Read More

Inclusion Criteria (All):

• 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.

Inclusion Criteria for Subjects with a Diagnosis of Probable Alzheimer's disease

• 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.

Exclusion Criteria:

• History or presence of a neurological diagnosis other than AD that may influence the outcome or analysis of the scan results examples include but are not limited to stroke, traumatic brain injury, space occupying lesions, non-Alzheimer's tauopathies, and Parkinson's disease.
• Subjects with a medical history that includes known autosomal dominant AD mutations in amyloid precursor protein (APP) or presenilin (PS) 1, PS 2 or mutations in genes that cause other types of autosomal dominant familial dementia, e.g., microtubule-associated protein tau (MAPT)
• History or presence of any clinically relevant hematological, hepatic, respiratory, cardiovascular, renal, metabolic, endocrine, or central nervous system (CNS) disease or other medical conditions that are not well controlled, may put the subject at risk, could interfere with the objectives of the study, or make the subject unsuitable for participation in the study for any other reason in the opinion of the principal investigator.
• Clinically relevant pathological findings in physical examination, ECG, or laboratory values at the screening assessment that could interfere with the objectives of the study.
• Known history of clinically significant infectious disease including AIDS or serological indication of acute or chronic hepatitis B or C or HIV infection.
• Women of childbearing potential must not be pregnant, or nursing and serum human chorionic gonadotropin (HCG) must be negative at the time of Screening Visit, and urine HCG must be negative on all subsequent visits.
• Loss or donation of more than 450 mL blood in the 4 months before screening or donation of plasma within 14 days of screening.
• Current symptoms of allergy and or severe allergy to drugs in medical history.
• History of drug or alcohol abuse or positive result from urine screen for drugs of abuse AD subjects on prescribed narcotics medications will not be excluded if urine drug screen is positive for the documented narcotic drugs.
• Have received an investigational medication within the last 3 months or 5 elimination half-life, whichever is longer, prior to administration of the radiotracer.
• Has had or is planning to have exposure to ionizing radiation that in combination with the study related tracer administrations and scanning procedures would result in a cumulative exposure that exceeds recommended exposure limits.
• Contraindications of MRI
• History of, or suffers from, claustrophobia or feels that he or she will be unable to lie still on their back in the MRI or PET scanner.