Imaging Tau in Alzheimer's Disease and Normal Aging
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: 18F-THK-5351; Lumbar Puncture (optional)
Intervention description: 18F-THK-5351 is a PET radioligand that binds abnormal tangles made of the protein tau. These tau tangles develop in the brain in people with Alzheimer's disease.; Subjects have the option to have lumbar puncture performed for the measurement of Alzheimer's disease biomarkers in cerebrospinal fluid.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: inflammation; aging; mild cognitive impairment

Summary:

      This study is being done to learn about tau tangles in Alzheimer's disease. A type of PET
      scan is used to measure the abnormal accumulation of protein called tau in the brain. These
      are thought to be involved in Alzheimer's disease. The investigators will also perform brain
      MRI and to tests to measure the participant's memory and thinking.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 50 and older.

          2. Meet criteria for either a) amnestic mild cognitive impairment (single or mixed
             domain) or mild Alzheimer's disease, or b) have no cognitive impairment, based on
             history, exam, neuropsychological testing, and consensus diagnosis. MCI and mild AD
             patients must have Clinical Dementia Rating scale score of 0.5 or 1. Unimpaired
             subjects must have Clinical Dementia Rating scale score of 0.

          3. Subjects unable to provide informed consent must have a surrogate decision maker.

          4. Written and oral fluency in English or Spanish.

          5. Able to participate in all scheduled evaluations and to complete all required tests
             and procedures.

          6. In the opinion of the investigator, the subject must be considered likely to comply
             with the study protocol and to have a high probability of completing the study.

        Exclusion Criteria:

          1. Past or present history of certain brain disorders other than MCI or AD.

          2. Certain significant medical conditions, which make study procedures of the current
             study unsafe. Such serious medical conditions include uncontrolled epilepsy and
             multiple serious injuries.

          3. Contraindication to MRI scanning.

          4. Conditions precluding entry into the scanners (e.g. morbid obesity, claustrophobia,
             etc.).

          5. History of kidney disease or presence of impaired kidney function based on laboratory
             tests at the screening visit.

          6. History of liver disease or presence of impaired liver function based on laboratory
             tests at the screening visit.

          7. Participation in the last year in a clinical trial for a disease-modifying drug for
             AD.

          8. Inability to have a catheter in subject's vein for the injection of radioligand.

          9. Inability to have blood drawn from subject's veins.