Update on the DIAN-TU-001 TRIAL

July 18, 2018

Update on the DIAN-TU-001 TRIAL:  Janssen BACE Inhibitor (JNJ-54861911/atabecestat) DRUG ARM DISCONTINUATION

The statement below is an update to the May 25^th announcement found on Janssen’s website.

Previously, Janssen observed elevations of liver enzymes 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.

After further consideration and consultation, Janssen has concluded that the benefit-risk balance of JNJ‑54861911 (atabecestat) is no longer favorable to continue development of atabecestat (Read more here). Therefore, all randomized participants in the DIAN-TU-001 trial’s atabecestat arm will be instructed to stop dosing with study drug.  The DIAN-TU is informing study participants, health authorities, the study ethics committees, and institutional review boards about this decision.

To facilitate transitioning the trial arm to another study drug, the DIAN-TU is modifying the current protocol to include a cognitive run-in period prior to randomization into study drug arms. This run-in period is intended to improve power, continue engagement of participants, and decrease total duration of the trial.  This cognitive run-in period was included in the funded NIH DIAN-TU NexGen trial grant (NIH R01AG053267, DIAN-TU Next Generation Prevention Trials).

We are in the process of considering the next drug for the third drug arm.  The DIAN-TU trial platform was designed to quickly adapt to new information about drugs as they are developed, and we plan to be doing this soon.

Thank you and the participants for your continued commitment.

Best regards,