Widespread use of biomarkers to screen Alzheimer’s patients in clinical trials offers greater precision than cognitive assessment tools in measuring dementia progression and enhances confidence that patients are accurately diagnosed, according to recommendations from the Alzheimer’s Disease Biomarker Expert Working Group.

Biomarkers have the potential to speed the identification of effective disease-modifying treatments and should be used for enrollment and as an outcome in clinical trials, said the Working Group.

"We view this white paper as representing a tipping point and a message to regulators that certain biomarkers already hold much promise to improve the process of testing new disease-modifying therapies for Alzheimer's," said Dennis J. Selkoe, professor at the Center for Neurologic Diseases at Brigham and Women's Hospital, Harvard and Harvard Medical School. "We recommend that investigators embrace the use of these biomarkers, as more frequent uptake can further hone their effectiveness."

Alzheimer’s biomarkers include structural MRI, brain amyloid imaging and cerebrospinal fluid levels of amyloid beta-protein 42 (AB42) and tau.

The Working Group was convened by the non-profit Alliance for Aging Research in cooperation with the U.S. Food & Drug Administration. The recommendations are published in a special issue of the journal Neurobiology of Aging.