Practice Effects and Amyloid Imaging Using 18F-PIB or Flutemetamol PET and FDG-PET
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: 18F-Flutemetamol
Intervention description: All subjects will undergo a PET scan with 18F-PIB, within six months of also undergoing an FDG-PET scan (PET scans will occur on separate days).
For the 18F-PIB PET scan: Approximately 185 MBq (5 mCi) of 18F-PIB will be injected intravenously and PET data collected for each subject.
The FDG-PET scan will follow the same procedures as routine scans obtained in a clinical setting (approximately 370 MBq of 18F-FDG will be injected intravenously and PET data collected for each subject). FDG-PET data will be used to correlate metabolic changes and for anatomic co-registration of 18F-PIB images.
Intervention MeSH terms: Flutemetamol
Phase: Phase 2
Study type: Interventional
Primary purpose: Screening
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Alzheimer's disease; Mild cognitive impairment; PET; Practice effects

Summary:

      Alzheimer's disease (AD) is the most common cause of progressive cognitive decline in the
      United States. AD is characterized by severe impairments in learning, memory and other
      cognitive abilities that significantly interfere with daily functioning. The neuropathologic
      hallmarks of AD consist of neuritic plaques, neurofibrillary tangles, and selective neuronal
      cell loss. Amyloid plaques, which contain Abeta protein, are believed to play an integral
      role in the development of AD. Elevated levels of Abeta in the brain are also correlated with
      cognitive decline.

      Alzheimer's (AD) develops insidiously, making it difficult to identify early, yet treatment
      is most effective when begun during the early stages of the disease. Thus, it has become
      important for researchers to identify markers of early AD. This project will examine the
      relationship between four potential markers that may indicate the early development of AD:

        1. Mild cognitive impairment (MCI)or normal cognition

        2. Practice effects

        3. Amyloid plaque binding on 18F-PIB PET

        4. Glucose hypometabolism on FDG PET

      This project will recruit 25 subjects from an ongoing community-based study of memory and
      practice effects in cognitively normal, community-dwelling individuals who are age 65 and
      over (NIA #5K23AG028417-05). Each subject will undergo positron emission tomography (PET)
      with both 18F-Flutemetamol and FDG.

      The overall objective of this companion project is to study the biodistribution and binding
      of 18F-Flutemetamol in these subjects using PET imaging, which will provide biological
      evidence to support the overall hypothesis that failure to benefit from practice on a
      learning paradigm is an early marker of AD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must be currently enrolled in an NIA-sponsored, community-based study of
             practice effects in non-demented adults age 65 and older living independently (NIA
             #5K23AG028417-05)

        Exclusion Criteria:

          -  History of neurological disease known to affect cognition (e.g., stroke, head injury
             with loss of consciousness of >30 minutes, seizure disorder, demyelinating disorder,
             mental retardation, etc.)

          -  Dementia based on DSM-IV criteria

          -  Current or past major psychiatric illness (e.g., schizophrenia, bipolar affective
             disorder)

          -  30-item Geriatric Depression Score >14

          -  Evidence of stroke or mass lesion on CT or MRI scan

          -  History of alcoholism or other substance abuse

          -  Current use of cholinesterase inhibitors, other cognitive enhancers, antipsychotics,
             or anticonvulsant medications

          -  History of radiation therapy to the brain

          -  History of significant major medical illnesses, such as cancer or AIDS

          -  Uncontrolled diabetes or blood glucose >180 mg/dl on the day of the FDG-PET scan

          -  Currently pregnant