Diagnostics Key to Effective Alzheimer’s Clinical Trials

Nearly one-third of all subjects enrolled in Alzheimer’s trials don’t match the protocol because they don’t actually have the disease, according to Dave Ricks, senior vice president and president with Lilly Bio-Medicines at Eli Lilly and Company. Weak diagnostics is one of the biggest problems, he added. “We need diagnostics before the symptoms appear,” he told attendees of the Pathways to Prevention policy discussion event on research and treatment for Alzheimer’s held in Washington, D.C., on June 23.

Clinical researchers and others recognize the need for advanced diagnostics, says Laurie Ryan, PhD, chief of the Dementias of Aging Branch and program director for Alzheimer’s disease clinical trials with the National Institute on Aging, National Institutes of Health (NIH). Calling it an “exciting time,” Ryan noted that NIH researchers are actively engaged in a number of trials to improve diagnostic capabilities, including brain scans to detect plaque build-up, blood tests to identity early signs of Alzheimer’s, and ways to identify other biomarkers that can serve as early warning systems and guide preventive treatment.

In comparison to other diseases, Alzheimer’s research is made even more difficult because it requires identifying tools in a number of areas to produce combination therapies, says Ronald Petersen, PhD, MD, director of the Mayo Clinic Alzheimer’s Disease Research Center.

The event was held in part to announce Lilly’s Alzheimer’s Readiness Project, an initiative designed to combine efforts to advocate on behalf of those with the disease, encourage effective and efficient research, and ensure a regulatory system that reflects the latest in scientific theories and conclusions.

For more details on the Readiness Project and Pathways to Prevention, visit: