Titusville, NJ, May 17, 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 called 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, which were serious in nature, have been observed in some study participants who received the Janssen BACE inhibitor, atabecestat. After a thorough evaluation of all available liver safety data from our studies, Janssen has concluded that the benefit-risk ratio is no longer favorable to continue development of atabecestat for people who have late-onset preclinical stage Alzheimer’s disease.
We are stopping the screening, randomization and dosing of 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.
More information about these studies can be found at the following links:
https://clinicaltrials.gov/ct2/show/NCT02569398?term=JNJ-54861911&rank=3
https://www.clinicaltrialsregister.eu/ctr-search/search?query=atabecestat
We are informing the clinical trial investigators, study participants, health authorities, ethics committees, and institutional review boards about this matter.
All participants in both studies will be offered safety and efficacy evaluations. We are updating the study protocol for longer-term follow up of participants who received atabecestat after they discontinue treatment. More than 600 people have received the study drug or placebo in these clinical trials.
Janssen continues to maintain a strong commitment to discovering and developing new treatments for this devastating disease. We thank all the volunteer study participants, their family members, and others who served as their study partners, and the staffs of the clinical study sites, for their time and dedication.