Alzheimers disease (AD) is a neurodegenerative disorder producing cognitive impairment and dementia in millions of elders. Currently no treatment is effective to slow the progression of AD. Major obstacles to developing effective treatments are: 1) a reliance on clinical symptoms and a lack of biomarkers for diagnosis 2) uncertainty concerning which biomarkers are best to identify disease stage and to predict progression 3) lack of standardization and 4) absence of naturalistic data to provide a basis for clinical trial design, problem in the field. To address these issues ADNI was funded for a total of $140 million, as a public/private partnership between the National Institute of Aging and a consortium of pharmaceutical companies (including Swiss companies). The goal of ADNI (from 2004-present see ADNI-info.org) has been to standardize and determine the value of MRI and PET imaging together with blood and CSF biomarkers for disease modifying Alzheimers treatment trials. In our initial project (ADNI1), we longitudinally studied: MCI (n= 400); AD (n= 200); Controls (n= 220) with clinical visits, neuropsychological assessments, MRI (1.5 T), FDG PET, blood and urine, and CSF. About 300 subjects from ADNI 1 continue to be followed. We found that the rate of hippocampal atrophy had high statistical power for measuring change over time. Normal healthy elders with APOE4 and/or low CSF Aβ amyloid have worse memory scores and higher rates of hippocampal atrophy, consistent with the view that about 30% of healthy elders in their 70s have preclinical AD pathology. Similar ADNI-like projects, with similar methods, are underway in Australia, Japan, Europe, China, Taiwan, and Korea leading to the World Wide ADNI network. The Parkinsons Progressive Markers Initiative (PPMI) has been modeled after ADNI. ADNI 2 with 3Tesla MRI and F18 amyloid PET imaging with Florbetapir on an additional 150 controls, 100 normal subjects with cognitive complaints, 300 subjects with early MCI, 150 subjects with late MCI , 150 subjects with dementia due to AD. Thus a total of about 1700 subjects have been enrolled and are followed longitudinally. Whole genome sequencing on 800 subjects is available. All ADNI data is available to all scientists in the world, on USC/LONI/ADNI, without embargo. Blood and CSF samples can be requested. ADNI methods are now widely used in clinical treatment trials, and have led to the development of the new research criteria. Over 600 papers have been written on ADNI data and all scientists are encouraged to explore this rich data set and publish their results. It is expected that ADNI will substantially contribute to identifying accurate diagnostic techniques and effective treatments to slow the progression and prevent Alzheimers disease.
Research And Development
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