The goal of this study is to determine whether imaging of the brain every six months can help predict the onset and monitor the progression of Alzheimer’s disease(AD). The imaging methods used are Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET) scans. In addition to imaging, the study is testing blood, and for some participants, cerebrospinal fluid (from lumbar puncture) to determine if biomarkers can predict and monitor the disease.

The Alzheimer’s Disease Neuroimaging Initiative (ADNI) study is in its fourth full year. Enrollment began in September 2005 and closed in August 2007 with 822 participants at 58 academic medical centers across the United States and Canada: 188 with Alzheimer’s disease, 405 with mild cognitive impairment (MCI) and 229 with normal memory. Enrollment was achieved at a swift pace; in fact, it was record breaking. Michael Weiner, M.D., professor of medicine, radiology, Psychiatry, and Neurology at the University of California, San Francisco, is directing the study.

The amount of new exciting information has been enormous. For example almost 100 scientific papers concerning ADNI data were presented at the 2008 International Conference on Alzheimer’s Disease. ADNI methods are now being used by pharmaceutical companies in their clinical studies of new drugs and the results of ADNI are being used by academic labs and industry to design future treatment studies. ADNI is accomplishing its goal to provide new methods and data which facilitate the testing of new treatments for Alzheimer’s.

The expeditious recruitment effort for ADNI would not have been possible without the support, enthusiastic cooperation and active involvement of the study’s participants. Without them researchers could not conduct this essential research that we predict will help us identify imaging and biological markers to measure the progression of MCI and the early stages of AD.

Background

The Alzheimer’s Disease Neuroimaging Initiative (ADNI), a landmark study that began in 2004, is a public-private research partnership tasked with identifying biomarkers to detect Alzheimer’s disease (AD). The study has gathered and analyzed thousands of brain scans, genetic profiles and biomarkers in blood and cerebrospinal fluid (CSF). The study was designed to enable researchers to follow AD as it progresses in an individual, from various points in the disease process.

In 2009, ADNI made a significant step forward in providing validation for a test that helps diagnose the beginning stages of AD sooner and more accurately by measuring levels of two biomarkers—tau and beta-amyloid proteins—in cerebrospinal fluid. Biomarkers in cerebrospinal fluid are revealing other changes that could identify which patients with MCI may develop Alzheimer’s.

The ADNI study includes scientists at 55 research centers in U.S. and Canada. Currently the study involves over 800 study participants from those without memory problems to mild cognitive impairment to AD. The study results are expected to provide researchers with a better understanding of AD progression in its earliest stages.

In 2010, funded by the federal stimulus package, the ADNI study moved into the “ADNI GO” phase. The ADNI GO research effort is the first of its kind to focus on participants who exhibit the earliest signs of memory loss in mild cognitive impairment – both thought to be precursors to AD. While the ADNI GO project work continues, the overall ADNI effort is rapidly moving into a third phase – known as “ADNI 2”.

ADNI 2

ADNI 2 will build upon the successes of earlier ADNI phases to identify the earliest signs of Alzheimer’s disease. Researchers are eager to determine when damage to the brain begins. Scientists suspect that identifiable changes to the brain take place well before AD symptoms appear. The ADNI2 phase of the study includes a large number of new volunteers in the earliest stages of cognitive impairment.

Researchers are seeking new volunteers to join those already participating in the study as it enters the ADNI2 phase. The study participants will be followed to define any changes in brain structure and function as people transition from normal cognitive aging to mild cognitive impairment (MCI) to AD. Like the previous phases of the study researchers will use imaging techniques and biomarker measures in blood and CSF specially developed to track changes in the living brain.

ADNI Technologies and Biomarkers

Some of the leading-edge technologies used in the ADNI studies are brain-imaging techniques, such as positron emission tomography (PET), including FDG-PET (which measures glucose metabolism in the brain); PET using a radioactive compound (Florbetapir F 18) that measures brain amyloid accumulation; that measures brain beta-amyloid; and structural MRI. Brain scans are showing scientists how the brain’s structure and function change as AD starts and progresses. Moreover, biomarkers in CSF are revealing other changes that could identify which patients with MCI will develop Alzheimer’s. ADNI 2 researchers are committed to identifying who is at risk for Alzheimer’s and to developing measurements to accurately track the progression of the disease in an individual. Moreover, ADNI 2 researchers hope to develop tests to measure the effectiveness of potential AD treatment interventions.

Volunteering for ADNI 2

ADNI 2 is actively enrolling through August 2013 and the study will run through 2017.

Researchers are looking for 550 volunteers between the ages of 55 and 90:

• 150 with no apparent memory problems
• 100 with a significant memory concern
• 100 with early mild cognitive impairment (eMCI)
• 150 with late mild cognitive impairment (lMCI)
• 150 with mild AD

All ADNI 2 volunteers should be:

• In good general health
• Fluent in English or Spanish
• Willing and able to undergo the test procedures)
• Accompanied by a study partner – a friend or relative who can go with the volunteer to all clinic visits and has at least 10 hours of contact per week with the volunteer.

U.S. Clinical Study Research Sites Participating in the ADNI 2 Study:

Canadian Clinical Study Research Sites Participating in the ADNI 2 Study:

For more information on this study go to: