Title: New Blood Test Can Predict Alzheimer’s, Mild Dementia

A blood test that can predict with 90 percent accuracy if a healthy person will develop mild cognitive impairment (MCI) or Alzheimer’s disease within three years has been discovered and validated by researchers at Georgetown and six other institutions.

The study team explains in the April issue ofNature Medicine(the paper was published online today) how they discovered and then validated a set of 10 lipid biomarkers in the blood that predict both conditions.

The discovery heralds the possible development of earlier treatment options for Alzheimer’s, when therapy could be more effective at slowing or even preventing onset of the disease.

‘WINDOW OF OPPORTUNITY’

From left, Georgetown researchers Dr. Howard J. Federoff; Amrita K. Cheema, associate professor of oncology and co-director of GUMC’s metabolomics shared resource; and Dr. Massimo S. Fiandaca, associate professor of neurology, are among the co-inventors of a blood test that can predict with 90 percent accuracy if a healthy person will develop mild cognitive impairment (MCI) or Alzheimer’s disease within three years.

“Our novel blood test offers the potential to identify people at risk for progressive cognitive decline and can change how patients, their families and treating physicians plan for and manage the disorder,” says the study’s corresponding author, Dr. Howard J. Federoff, executive vice president of health sciences at Georgetown University Medical Center.

There is currently no cure or effective treatment for Alzheimer’s disease, which, according to the World Health Organization, is expected to double every 20 years worldwide – from 35.6 million individuals in 2010 to 115.4 million by 2050.

Federoff, also a professor of neurology, explains there have been many efforts to develop drugs to slow or reverse the progression of Alzheimer’s disease, but all of them have failed. He says one reason may be the drugs were evaluated too late in the disease process.

“The preclinical state of the disease offers a window of opportunity for timely disease-modifying intervention, and biomarkers defining this asymptomatic period are critical for successful development and application of these therapeutics,” says Federoff.

In addition to several Georgetown investigators, other team members include researchers from the University of Rochester, the University of California-Irvine, Rochester General Hospital, Unity Health System in Rochester, Temple University School of Medicine andRegis University School of Pharmacy in Denver.

‘MAJOR STEP FORWARD’

We consider our results a major step toward the commercialization of a preclinical disease biomarker test that could be useful for large-scale screening to identify at-risk individuals.”

—Dr. Howard J. Federoff, EXECUTIVE VICE PRESIDENT OF HEALTH SCIENCES

“The lipid panel was able to distinguish with 90 percent accuracy these two distinct groups – cognitively normal participants who would progress to MCI or AD within two to three years, and those who would remain normal in the near future,” says Federoff, who also serves as executive dean of the School of Medicine.

Researchers say the panel reveals changes in the breakdown of neural cell membranes resulting in 10 identifiable lipids, or metabolites, circulating in the blood. In particular, two of the 10 metabolites have strong links to the neuropathology of Alzheimer’s.

“We consider our results a major step toward the commercialization of a preclinical disease biomarker test that could be useful for large-scale screening to identify at-risk individuals,” Federoff concludes. “We’re intending to design a clinical trial where we’ll use this panel to identify people at high risk for Alzheimer’s to test a therapeutic agent that might delay or prevent the emergence of the disease.”

Federoff and Georgetown researchers Amrita K. Cheema and Massimo S. Fiandaca along with Mark Mapstone of the University of Rochester are named as co-inventors on a patent application filed by Georgetown and the University of Rochester related to the technology described.

The National Institutes of Health (R01AG030753) and the Department of Defense (W81XWH-09-1-0107) funded the study.