The statement below is an update to our May 17, 2018, announcement found here.
Titusville, New Jersey, May 25, 2018 - At Janssen, the safety and well-being of people who participate in our clinical trials are of utmost importance to us. For the past several years, we have been studying an investigational drug, atabecestat, which is a BACE inhibitor. The goal of this research is to slow cognitive decline in people at risk for Alzheimer’s dementia.
Elevations of liver enzymes have been observed in some study participants who received atabecestat, including two patients who had high elevations of liver enzymes, placing them at increased risk for severe liver injury. These patients remain clinically stable, and their liver enzyme levels have normalized.
Earlier this month we announced that we stopped studying atabecestat in our Phase 2b/3 EARLY study in late-onset preclinical stage Alzheimer’s disease and in a Phase 2 long-term safety study.
In collaboration with the Dominantly Inherited Alzheimer’s Network Trial Unit (DIAN-TU), we recently started a clinical trial of atabecestat to test the mechanism of beta secretase inhibition in people who have dominantly inherited genetic mutations that cause early-onset Alzheimer’s disease.
Given the different prognosis of patients with dominantly inherited Alzheimer’s disease, we have decided to continue dosing of patients who are receiving atabecestat or placebo in the Dominantly Inherited Alzheimer’s Network Trial Unit (DIAN-TU) study, but have suspended enrollment while we and the DIAN-TU team explore options to improve the benefit / risk for these patients. We have increased monitoring and other measures to improve hepatic (liver) safety.
Working closely with the DIAN-TU, we are informing study participants, health authorities, the study ethics committee, and institutional review board about our decision.
Janssen continues to maintain a strong commitment to discovering and developing new treatments for Alzheimer’s dementia.
We are particularly grateful to the people who may be at risk for Alzheimer’s dementia who volunteer to participate in the DIAN-TU study. We also thank their family members and study partners, and the DIAN-TU scientists and staff at Washington University in St. Louis, Missouri and the international investigators for their time and dedication.