Alzheimer's Disease Neuroimaging Initiative 2
Condition: Mild Cognitive Impairment (MCI); Alzheimer's Disease (AD); Significant Memory Concern (SMC); Early Mild Cognitive Impairment (EMCI); Late Mild Cognitive Impairment (LMCI)
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Study type: Observational

Summary: 
      The purpose of this study is to build upon the information obtained in the original
      Alzheimer's Disease Neuroimaging Initiative (ADNI1) and ADNI-GO (Grand Opportunity; a study
      funded through an NIH grant under the American Recovery and Reinvestment Act), to examine how
      brain imaging technology can be used with other tests to measure the progression of mild
      cognitive impairment (MCI) and early Alzheimer's disease (AD). ADNI2 seeks to inform the
      neuroscience of AD. This information will aid in the early detection of AD, and in measuring
      the effectiveness of treatments in future clinical trials.
    

Detailed description: 
      The Alzheimer's Disease Neuroimaging Initiative (ADNI) began in October 2004 as a landmark
      study with a public-private partnership that gathered and analyzed thousands of brain scans,
      genetic profiles and biomarkers in blood and cerebrospinal fluid (CSF). Although the original
      goal was to define biomarkers for use in clinical trials to determine the best way to measure
      treatment effects of Alzheimer's disease (AD), the goal has been expanded to using biomarkers
      to identify AD at a pre-dementia stage. ADNI1 involves scientists at 59 research centers, 54
      in the U.S. and five in Canada. Originally 800 participants were enrolled. This group was
      comprised of 200 participants with AD, 400 with mild cognitive impairment (MCI) and 200 with
      normal cognition. In ADNI-GO, an estimated 200 participants with early amnestic MCI (EMCI)
      were enrolled to understand and characterize the mildest symptomatic phase of AD. An
      additional 650 participants will be enrolled under ADNI2.

      Some of the leading-edge technologies under study are brain-imaging techniques, such as
      positron emission tomography (PET), including FDG-PET (which measures glucose metabolism in
      the brain); PET using a radioactive compound (Florbetapir F 18) that measures brain
      beta-amyloid; and structural MRI. Brain scans are showing scientists how the brain's
      structure and function change as AD starts and progresses. Biomarkers in cerebrospinal fluid
      are revealing other changes that could identify which patients with MCI will develop
      Alzheimer's. Scientists are looking at levels of beta-amyloid and tau in cerebrospinal fluid.
      (Abnormal amounts of the amyloid and tau proteins in the brain are hallmarks of Alzheimer's
      disease.)

      ADNI2 extends the work of ADNI1 and ADNI GO to understand the progression of AD. The overall
      goal is to determine the relationships among the clinical, cognitive, imaging, genetic and
      biochemical biomarker characteristics of the entire spectrum of AD, as the pathology evolves
      from normal aging through very mild symptoms, to MCI, to dementia.

      The overall impact of this study will be increased knowledge concerning the sequence and
      timing of events leading to MCI and AD, development of better clinical and imaging/fluid
      biomarker methods for early detection and for monitoring the progression of these conditions,
      and facilitation of clinical trials to slow disease progression, ultimately contributing to
      the prevention of AD.
    

Intervention name(s): Florbetapir; Flortaucipir
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive a single bolus intravenous injection of 10 mCi (370 MBq) (+/- 10%) florbetapir F18. At approximately 50-minutes post dose, scanning will begin. An approximately 20-minute image acquisition scan will be performed.; Participants will receive a single bolus intravenous injection of 10 mCi (370 MBq) flortaucipir injection followed by a saline flush. At approximately 75-minutes post dose, scanning will begin. An approximately 30-minute image acquisition scan will be performed.
Other intervention name(s): 18F-AV-45, LY3078786; 18F-AV-1451 (also known as [F-18]T807 or LY3191748)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Community Sample
      
Biospecimen description: 
      blood, urine, cerebrospinal fluid
    
Keywords: amyloid; plaques; neuroimaging; biomarkers; cognition disorder; early detection; Amnestic MCI; pre-dementia; dementia; Alzheimer's disease; tau