Study Objectives

The three phases of the ADNI study have created a linear evolution in the research. Some participants were carried forward from previous phases for continued monitoring and new participants were added with each phase to further investigate the evolution of Alzheimer’s disease.

The distinct goals of each phase are outlined below.

ADNI1

Participant Pool:

  • 200 Normal Controls
  • 400 MCI
  • 200 Mild AD
  1. Develop improved methods that create uniform standards for acquiring longitudinal, multi-site MRI and PET data on patients with Alzheimer’s disease (AD), mild cognitive impairment (MCI), and elderly controls.
  2. Acquire a generally accessible data repository which describes longitudinal changes in brain structure and metabolism as well as clinical cognitive and biomarker data for the validation of imaging surrogates.
  3. Develop methods which will provide maximum power to determine treatment effects in trials involving these patients.
  4. Test a series of hypotheses based on the clinical and biomarker data.

ADNI GO

Participant Pool:

  • 200 EMCI (new)
  • 500 Normal Controls and MCI from ADNI1
  1. Define and characterize the stage of the AD spectrum that precedes MCI by enrolling 200 subjects in the mildest symptomatic phase of AD (EMCI).
  2. Perform F18 amyloid imaging on the CN and LMCI subjects from ADNI1 and the newly enrolled EMCI subjects. FDG PET will be performed in association with F18 amyloid imaging.
  3. Establish a national network for F18 amyloid imaging and test hypotheses concerning the prevalence and severity of brain amyloid accumulation and its relationship to current and previous changes of clinical state, MRI, FDG-PET, CSF and plasma biomarkers from ADNI1.
  4. Collect 3T MRI on all newly enrolled subjects at Baseline, Month 3, Month 6, and Month 12.
  5. Continue longitudinal clinical/cognitive and 1.5T MRI studies of approximately 500 LMCI and Cognitively Normal subjects from ADNI1 for an additional 2 years.
  6. Collect and analyze blood and CSF biomarkers from all newly enrolled EMCI and follow-up subjects.
  7. Collect blood samples for DNA and RNA extraction. Newly enrolled subjects will also have samples collected for Cell Immortalization and APOE genotyping.

ADNI2

Participant Pool:

  • 150 Normal Controls (new)
  • 450-500 CN and MCI from ADNI1 (approximate)
  • 150 EMCI (new)
  • 200 EMCI from ADNI GO (approximate)
  • 150 LMCI (new)
  • 200 mild AD (new)
  1. Determine the relationships among clinical, imaging, genetic, and biochemical biomarker characteristics of the entire spectrum of Alzheimer’s disease (AD), as the pathology evolves.
  2. Inform the neuroscience of AD, identify diagnostic and prognostic markers and outcome measures that can be used in clinical trials, and help develop the most effective clinical trial scenarios.
  3. Develop uniform standards for acquiring longitudinal multisite MRI and PET data on patients with AD, MCI, and elderly controls.
  4. Perform longitudinal clinical, cognitive, MRI, PET (18F-Florbetapir and FDG), and blood and CSF biomarker studies on 550 newly enrolled subjects in addition to continuing these studies for approximately 700 subjects from ADNI1 and ADNI GO for an additional 5 years.
  5. Collect blood samples for DNA and RNA extraction. Newly enrolled subjects will also have samples collected for Cell Immortalization and APOE genotyping.
  6. Validate the clinical diagnoses and imaging and biomarker surrogates through europathological examination of ADNI1, GO and ADNI2 participants who come to autopsy.

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