First described more than 100 years ago, Alzheimer’s disease (AD) has no cure or lasting, effective treatment. Currently, more than 5 million people in the United States suffer from it and its incidence is projected to increase dramatically over the next 20 years.

The Alzheimer’s Disease Neuroimaging Initiative (ADNI) is conducted by the National Institute on Aging, in conjunction with other federal agencies and private-sector corporations and organizations. The NIH’s largest public-private partnership on brain research, ADNI tracks normal, mildly cognitively impaired (MCI), and Alzheimer’s disease brain changes to measure the progression of the condition. This study is co-funded by NIH and the private sector through support provided to the foundation by 20 pharmaceutical companies and two non-profit organizations.

ADNI is using MRI and PET imaging, as well as laboratory and cognitive testing of 821 normal, mildly cognitively impaired and Alzheimer’s disease patients. Among the goals of the study is to provide better tools for carrying out effective clinical trials and identifying biomarkers that can predict clinical outcome.

ADNI has, in fact, led to improved understanding of how to conduct such trials in a multi-center setting by employing imaging technologies to analyze blood and cerebrospinal fluid biomarkers. As a result, pharmaceutical companies developing Alzheimer’s disease drugs have begun using ADNI methodologies in their clinical trials. The idea is that by using drugs to treat validated biomarkers of Alzheimer’s disease instead of treating less-precise cognitive measures, the cost and length of drug trials can be reduced.

Already, more than 400 investigators from across the world have accessed ADNI data for their own analyses. The study has also fostered similar projects in Australia, Japan, Europe and China. Additional projects are being discussed in Korea, India and South America. The establishment of worldwide standards and a worldwide network for clinical trials has huge implications for the scientific community.

Growing data from ADNI’s subjects at 57 sites across the United States and Canada are being published, as well as findings and other materials on ADNI’s two web sites, www.loni.ucla.edu/ADNI and www.adni-info.org.

ADNI was also the subject of an October 16, 2009 article in Science, “Alzheimer’s Biomarker Initiative Hits Its Stride.”

The Foundation for NIH has raised $27 million from the private sector to support this $67 million initiative.

Partners
Abbott
Alzheimer's Association
Alzheimer's Drug Discovery Foundation
AstraZeneca
Bayer Healthcare Pharmaceuticals Inc.
Bristol-Myers Squibb Company
Eisai Inc.
Elan Pharmaceuticals, Inc.
GE Healthcare
Genentech, Inc.
GlaxoSmithKline
Innogenetics N.V.
Johnson & Johnson
Eli Lilly & Company
Medpace, Inc.
Merck & Co., Inc.
Novartis Pharmaceuticals Corporation
Pfizer Inc
F. Hoffmann-La Roche Ltd.
Schering-Plough
Synarc
Wyeth

ADNI PROJECTS

ADNI GENOTYPING ANALYSIS
In 2009, this project announced that a high-density, genome wide analysis of ADNI participants was nearly complete, with data available to scientists worldwide for further analysis. This data will be used by researchers to search for genes that contribute to the development of Alzheimer’s disease. One major gene identified with Alzheimer’s disease risk, APOE, has been consistently shown to be associated with the form of the disease arising later in life that accounts for 95 percent of all cases. Variants in other groups of genes are suspected to play a role in susceptibility to Alzheimer’s disease and may influence the age of onset, expression and rate of progression of other neurodegenerative changes in the brain.

Partners
Anonymous Foundation
Gene Network Sciences
Merck & Co., Inc.
Pfizer Inc.

ADNI- Cerebrospinal Fluid Collection Extension
This project makes possible the collection and measurement of longitudinal changes in cerebrospinal fluid, Tau and A beta biomarkers over a three-year span, up from the one-year timeline funded in the original ADNI grant, in 50 cognitively normal, 50 mildly cognitively impaired and 50 Alzheimer’s Disease subjects. 

Partners
Alzheimer’s Association
Anonymous Foundation
AstraZeneca
Cure Alzheimer’s Fund
Merck & Co., Inc.
Pfizer Inc

ADNI Pittsburgh Compound B (PIB) Substudy
This project is using PET and Pittsburgh Compound B (PIB) as tools to develop neuroimaging and/or biochemical markers that may serve as surrogate endpoints in mildly cognitively impaired/Alzheimer’s Disease clinical trials. The use of PIB enables physicians to see the pathologic progression of the disease (demonstration of the presence of beta-amyloid plaques and neurofibrillary tangles), which previously was typically available only at autopsy.

Partners
Alzheimer’s Association
GE Healthcare

ADNI II

As many as 5.3 million Americans are currently living with Alzheimer's disease. Today there is no cure, no disease-modifying treatment, and no way to prevent the disease.

Launched in 2004, ADNI is scheduled to conclude in late 2010. Study investigators have submitted a grant renewal application to NIH, which would continue the ADNI study for an additional five years (from late 2010 to late 2015). ADNI II would continue to track the current ADNI subjects and would enroll additional normal, mildly cognitively impaired, and Alzheimer’s disease patients, as well as people with early or very mild cognitive impairment. Additional plans for ADNI II include PET imaging scans on every new patient enrolled.

ADNI II Partners

Abbott
Alzheimer’s Association
Alzheimer’s Drug Discovery Foundation
Amorfix Life Sciences
AstraZeneca
Bayer HealthCare
BioClinica
Biogen Idec
Bristol-Myers Squibb
Canadian Institutes of Health Research
Eisai, Inc.
Elan Pharmaceuticals
Eli Lilly and Company
Roche
GE Healthcare
Genentech
Innogenetics
Janssen Alzheimer Immunotherapy
Johnson & Johnson
Medpace
Merck
Meso Scale Diagnostics
Novartis Pharmaceuticals
Pfizer, Inc.
Servier
Synarc
Takeda