A new phase of the Alzheimer’s Disease Neuroimaging Initiative will start in the fall of 2016.
The ongoing Alzheimer’s Disease Neuroimaging Initiative (ADNI) recently received a $40 million award from the National Institutes of Health (NIH) to launch a new phase of the study.
A contribution of $20 million is also anticipated from private contributors through the Foundation for the National Institutes of Health (FNIH). Current private sector funding has gained more than $14 million in contributions from various organizations, including big name pharmaceutical companies such as AbbVie, Merck, and Pfizer.
The funding will be distributed over the next 5 years to the 12-year ongoing study, which analyzes brain and fluid biomarkers of Alzheimer’s disease. The new phase, ANDI3, will use new technologies in brain imaging to further develop ways to speed clinical trials by providing scientists with Alzheimer’s disease-related biomarkers, according to the NIH.
ADNI3 will enroll up to 1200 patients over 55-years-old, and will include the 800 current patients. Patients enrolled will have normal cognition, mild cognitive impairment, and Alzheimer’s disease.
“These insights are vital to researchers and clinicians working worldwide in their selection of clinical trial volunteers and the testing of promising interventions,” said Richard J. Hodes, MD, director, National Institute on Aging, a supporter of the study.
In the ongoing study, investigators identified changes in clinical and cognitive tests with biomarkers in the blood, cerebrospinal fluid, and DNA samples that have been donated. Current brain scans can identify alternations in brain volume, white matter, connectivity between brain regions, glucose metabolism, and amyloid plaques.
In the newest phase of the study, brain scans will also be able to detect tau protein tangles, which have been shown to spread through extracellular space surrounding brain cells, and contributing to the disease. Researchers will examine how and where the protein builds, and how it can affect amyloid plaques, according to the NIH.
Research regarding biomarkers has led to the identification of risk factors, and show how brain changes correspond with clinical findings. New ADNI discoveries have also led to a more advanced clinical design, and have led to testing promising treatments early in the disease, according to the National Institutes of Health.
“ADNI3 will move the bar higher still in this collaborative effort to gain a clear understanding of the subtle Alzheimer’s-related brain changes in volunteers, long before symptoms appear, and the biological changes that mark its progression,” said NIA Director Richard J. Hodes, MD. “These insights are vital to researchers and clinicians working worldwide in their selection of clinical trial volunteers and the testing of promising interventions.”
Researchers also analyze connections between the structure and function of brain changes. They will also use the Financial Capacity Instrument to see how patients handle money and pay bills, since difficulty with these skills is associated with the early stages of Alzheimer’s disease, according to the NIH.
If the findings are validated, researchers may be able to create a function test that can be used in clinical settings. Participants will also regularly fill out questionnaires about their health, lifestyle, and medical history, as well as taking computerized tests to measure cognitive function.
“We are thrilled to embark on this next phase of discovery, enhanced by sophisticated new technologies and computational methods that we could only dream about when we launched the study in 2004,” said principal investigator Michael Weiner, MD. “ADNI has made a profound difference in clinical trials, developing and refining the biomarker tools needed to see Alzheimer’s-related brain changes in the living brain—even in people free of symptoms. ADNI3 will play an even more influential role as these biomarkers are enlisted in the search for treatments for this devastating disorder.”