Alzheimer’s Disease Neuroimaging Initiative (ADNI)

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Summary

  • Study director: Howard Rosen, MD
  • Sponsor: National Institute on Aging (NIA)
  • Recruiting?: Yes
  • Official study title: Alzheimer’s Disease Neuroimaging Initiative (ADNI)
  • Conditions studied: Mild cognitive impairment (MCI), Alzheimer's disease (AD) and healthy aging
  • Purpose: The goal of this study is to identify the best imaging modalities and methods of analysis for tracking Alzheimer’s Disease (AD) over time. The results from this study will be used to aid clinical drug trials that will use neuroimaging data as an outcome measure. The study will also provide additional information about the relative value of different imaging techniques for diagnosis, and the value of imaging versus other blood and cerebrospinal fluid (CSF) biomarkers.

Eligibility

  • Inclusion criteria: Participants must be between the ages of 55 and 90 and be in good general health with memory problems or concerns. Participants will need a reliable study partner who has frequent contact with the participant, is available to provide information about the participant, and who can accompany the participant to research visits as needed. All participants must be willing and able to undergo testing procedures, including neuroimaging, and agree to longitudinal follow-up.
  • Exclusion criteria: Any significant neurological disease other than Alzheimer's disease including Parkinson’s disease, multi-infarct dementia, Huntington’s disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy (PSP), seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurological deficits or known structural brain abnormalities. Any significant systemic illness or unstable medical condition. Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body. Longstanding (>10 years) history of alcohol or substance abuse with continuous abuse up to and including the time that the symptoms leading to clinical presentation developed. History of major depression, bipolar disorder or schizophrenia that puts assessment of cognitive impairment into question. Clinically significant abnormalities in B12, RPR or TFTs that might interfere with the study.

What is Involved?

  • Testing: Neurological and physical examinations; interview with study partner; MRIs; PET scans; cognitive testing; detailed family history; blood and urine specimen collection for cell line generation and biomarker analysis; lumbar punctures (LP) for CSF specimen collection and biomarker analysis; questionnaires for participant and study partner.
  • Frequency of visits: After an initial screening visit and MRI, there will be a baseline visit, a 6-month visit, and then 1 visit every 12 months for 48 months from the baseline. Additionally, there will be telephone calls at the 6-month mark between each yearly visit, up to 54 months from the start of the study. Participants will be assessed in Moffitt Hospital in the Clinical & Translational Science Institute (CTSI) Clinical Research Center, as well as at the UCSF Memory and Aging Center. MRIs will be done at the Neuroscience Imaging Center (NIC), and PET scans will be conducted at the UCSF China Basin campus.
  • Materials needed prior to evaluation: None
  • Costs: No costs will be charged for any of the study procedures. Participants will be sent a check for $100 for every clinic visit and $200 for every lumbar puncture.

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