$40M NIH Award Expands Groundbreaking Alzheimer’s Study; Recruitment to Begin Soon

The National Institutes of Health’s recent $40 million award over the next five years will provide a new stage of research for the Alzheimer’s Disease Neuroimaging Initiative (ADNI), an NIH public-private partnership.

The ADNI is supported by the Foundation for the National Institutes of Health (FNIH), which anticipates $20 million in contributions from the private sector. The two awards will fund ADNI3, an extension of the global research effort that supports the investigation and development of treatments that slow or stop the progression of Alzheimer’s disease. Recruitment of hundreds of new volunteers for ADNI3 is planned to begin this fall.

ADNI3 is a five-year extension of the ADNI study, which is now on its 12th year. The multi-site, longitudinal study assesses clinical, imaging, genetic, and biospecimen biomarkers through the process of normal aging to early mild cognitive impairment (EMCI), to late mild cognitive impairment (LMCI), to dementia or Alzheimer’s.

Using established methods for imaging and biomarker collection and analysis, ADNI facilitates a way for scientists to conduct research and share compatible data with other scientists around the globe.

ADNI3 will use cutting-edge methods in brain imaging to speed clinical trials by offering investigators the biomarkers required to detect the onset of Alzheimer’s and track the progression of the disease.

The study matches clinical and cognitive testing changes with Alzheimer’s-related changes detected in the volunteers’ blood, cerebrospinal fluid, and DNA.

Brain scans are used to detect brain volume changes as well as white matter integrity, functional connectivity between brain regions, glucose metabolism, and the buildup of amyloid protein plaques — a hallmark of Alzheimer’s. ADNI3 will add brain scans that detect tau protein tangles, another Alzheimer’s indicator.

The ADNI unites researchers with study data as they work to define the progression of Alzheimer’s disease. ADNI researchers collect, validate, and utilize data such as MRI and PET images, genetics, cognitive tests, CSF and blood biomarkers as predictors for the disease.

ADNI is supported by the NIH’s National Institute on Aging (NIA) through a grant to the Northern California Institute for Research and Education in San Francisco. The study’s prinicipal investigator is Dr. Michael Weiner, MD, of the San Francisco Department of Veterans Affairs Medical Center and the University of California, San Francisco (UCSF).

By identifying and validating such biomarkers as abnormal levels of amyloid protein, ADNI has led to insights on who may be at risk of developing Alzheimer’s and how disease-related brain changes match clinical findings.

“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,” NIA Director Dr. Richard J. Hodes, MD., said in a press release. “These insights are vital to researchers and clinicians working worldwide in their selection of clinical trial volunteers and the testing of promising interventions.”

Weiner said he and his team are thrilled to begin the newest phase of discovery, “enhanced by sophisticated new technologies and computational methods that we could only dream about when we launched the study in 2004.”

“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,” Weiner said. “ADNI3 will play an even more influential role as these biomarkers are enlisted in the search for treatments for this devastating disorder.”

ADNI3 will use new tools and measures such as tracers that image tau protein tangles in volunteers’ living brains, which will offer scientists knowledge about where and how the protein builds in the brain, and how it may interact with amyloid protein plaques to drive the progression of Alzheimer’s disease.

ADNI3 will also use MRIs of the brain with methods developed by the Human Connectome Project to seek to understand how the connections between the structure and function of the brain change in Alzheimer’s patients.

Also, because handling money is often an early sign of Alzheimer’s, the Financial Capacity Instrument (FCI) will be used to evaluate volunteers on real-life money skills. Declines in the FCI performance will the used to assess who is at risk for developing Alzheimer’s among those with normal cognitive skills or mild cognitive impairment.

Up to 1,200 volunteers over the age of 55 years will join the 800 volunteers now taking part in the study at 60 research sites in the U.S. and Canada. The volunteers include people with normal cognition, mild cognitive impairment, and those with full blown Alzheimer’s.

Volunteers will be recruited and tracked online from the Brain Health Registry. They will be asked to complete questionnaires about their medical history, lifestyle, and health, and will be assessed via computerized tests on their memory, attention, and other cognition measures.

ADNI3 builds upon the successes of earlier ADNI study phases (ADNI, ADNI-GO, and ADNI2), and it is also uses insights gained from a study supported by the U.S. Department of Defense on the role of traumatic brain injury and post-traumatic stress disorder on developing Alzheimer’s in Vietnam veteran volunteers.

More information about ADNI3 and recruitment for the the study can be found by visiting http://adni.brainhealthregistry.org or by calling 1-888-2-ADNI-95 (888-223-6495).