ADNI: Alzheimer's Disease Neuroimaging Initiative
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Observational

Summary: 
      The purpose of this study is 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). This information will aid future clinical trials by providing a standard
      assessment tool to measure the effects of treatments being studied.
    

Detailed description: 
      This study will test whether serial magnetic resonance imaging (MRI), positron emission
      tomography (PET), other biological markers, and clinical and neuropsychological assessment
      can be combined to measure the progression of mild cognitive impairment (MCI) and early
      Alzheimer's disease (AD). The information obtained by studying changes in the brain images of
      MCI and AD patients and healthy individuals, as well as other assessment tools, will be used
      to determine the best methods for measuring treatment effects in patients with MCI and AD.

      Approximately 800 participants, ranging in age from 55 to 90, will be recruited for the
      study: 400 patients with MCI, 200 with early AD, and 200 normal controls. Patients with MCI
      and normal controls will be followed for 3 years, and those with AD will be followed for 2
      years. At 6-month intervals, all participants will be seen in person or contacted by
      telephone. All participants will undergo repeated scanning and blood and urine biomarkers
      will be collected at the time of each scan. All patients will be asked if they are willing to
      undergo lumbar puncture at baseline and year one, with the goal of a minimum of 20% and as
      many as 50% of each group providing CSF (cerebrospinal fluid) samples for analysis and
      storage for future analyses.

      NOTE: Beginning in Spring 2007 a subset of the ADNI participants will be offered the
      opportunity to participate in a supplemental study. The PIB (Pittsburgh Compound B) study
      provides imaging of amyloid plaque burden. PIB PET scans will be conducted in 24 control, 48
      MCI, and 24 AD participants at approximately 16 ADNI PET sites. For entering participants
      with no previous PET FDG scans, controls and MCI participants will be scanned with PIB at
      entry (baseline), 12, 24, and 36 months, and AD participants will be scanned with PIB at
      entry (baseline), 12, and 24 months. For participants who have undergone previous (baseline
      and 6 month) PET FDG scans, controls and MCI participants will be scanned with PIB at 12, 24,
      and 36 months, and AD participants will be scanned with PIB at 12 and 24 months.
    

Intervention name(s): Magnetic Resonance Imaging (MRI); Positron Emission Tomography (PET); Lumbar Puncture (LP)
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): MRI scans; PET scans; collection of cerebrospinal fluid
Other intervention name(s): spinal tap
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        community sample
      
Biospecimen description: 
      blood, urine, cerebrospinal fluid
    
Keywords: neuroimaging; brain metabolism; biomarkers; cognition disorder; Mild Cognitive Impairment