Alzheimer’s Inhibitor BACE to Enter Worldwide Phase 2/3 Trial

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by Magdalena Kegel |

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A clinical trial managed by Jansen and University of Southern California’s Alzheimer's Therapeutic Research Institute will explore the efficacy of a BACE blocker in presymptomatic individuals.

Alzheimer’s Therapeutic Research Institute (ATRI) at the University of Southern California, and Janssen Research & Development will collaborate for a  Phase 2/3 clinical trial of Jansen’s BACE blocker intended to delay or even prevent Alzheimer’s symptoms.

The BACE blocker is a drug that prevents the action of an enzyme involved in the production main cause of plaque build-ups in the brains of Alzheimer’s patients – amyloid-β protein.

People who currently show no Alzheimer’s symptoms but are older than age 60 and have an accumulation of amyloid-β in their brains, will be the focus of the study.

Participants will be followed over time, while repeatedly being tested for amyloid-β levels and cognitive performance. The participants will be randomized to receive either the drug candidate or placebo in a double-blind manner.

“We are now looking at the stage of Alzheimer’s that precedes even mild symptoms,” said Paul Aisen, founding director of USC ATRI and professor of neurology at the Keck School of Medicine, in a news release. “It is our view that drugs such as BACE inhibitors may be most effective at the earliest stages of the disease.”

Enrolling 1,600 patients worldwide, the trial will encompass treatment centers in North America, Europe, Japan, and Australia. In North America alone, 660 participants across 75 centers will be included.

Aisen and Reisa Sperling, director of the Center for Alzheimer’s Research and Treatment at Harvard Medical School, will be co-principals of the investigation.

ATRI is being financially supported for the project via funding by Jansen. Both groups will oversee the study with ATRI managing study centers in the U.S. and Canada. Sites in the remaining nations will be managed by Quintiles.

“There is a lot of optimism that research may be ushering in a new era in Alzheimer’s drug development,” said Gary Romano, head of Alzheimer’s disease clinical development at Janssen. “We may be able to treat the disease using interventions before it becomes advanced, much like you treat high cholesterol to mitigate the risk of heart attacks.”

Jansen’s BACE blocker is licensed from the Japanese pharmaceutical company Shionogi & Co.