HCLSIG BioRDF Subgroup/Demo Thoughts/ADNI

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Alzheimer's Disease NeuroImaging Initiative

Overall Goals

ADNI will compare neuroimaging, biological and clinical information from study participants seeking correlations among the data that will track the progress of memory loss from its earliest stages. Neuroimaging research has suggested that PET or MRI may serve as a more sensitive and consistent measure of disease progression than the neuropsychological and cognitive assessments now typically used in research. Ultimately, standardizing the methodology for neuroimaging could provide a better way to compare results from different trials and studies, a major goal of the Initiative.

  • A longitudinal, prospective, naturalistic study of normal aging, mild cognitive impairment, and early AD to evaluate neuroimaging and potential biomarkers.
  • A public database, in which investigators participating and those not participating in the initiative can use the data for analyses.
  • Identify neuroimaging and biomarkers that can track the progress of the MCI and AD and monitor the effectiveness of new treatments.
  • Validate imaging and biomarker data by correlating with neuropsych and behavioral data.
  • Improve methods for clinical trials
  • Funding from the NIH, and private partners include Pfizer, Wyeth, Lilly, Merck, GSK, AZ, and Novartis.

Subject Design

  • MCI (n=400): 0, 6, 12, 18, 24, 36 months
  • AD (n=200): 0, 6, 12, 24 months
  • Controls (n=200): 0, 6, 12, 18, 24, 36 months
  • Clinical, MRI (1.5T) at all time points
  • FDG PET at all time points in 50%
  • 3T MRI at all time points in 25%
  • Blood and urine at all time points from all subject, CSF from 20% of subjects less often
  • Patient enrollment began April-July 2005 and ended July 2006. Completion of project in 2009.

Data Sharing Agreement

Data Use and Publications Policy Data Use Agreement

Biomarker Core

  • Biomarker core is led by John Trojanowski at the University of Pennsylvania.
  • Goal is to create an ADNI biological fluid bank in the biomarker core.
  • Measure the following analytes in ADNI subjects: ApoE genotype, Homocysteine (blood), Isoprostanes (blood, urine, CSF), Tau and AB (CSF), and Sulfatides (CSF).

Image Core

  • Many studies have shown changes in the brain of normal aging and AD.
  • Structural MRI shows shrinkage, especially of median temporal lobe and cortex.
  • FDG PET shows reduced metabolism.
  • AD biomarkers can improve diagnosis and reflect disease progression
  • Great potential for use in clinical trials and for early detection.