Roche has discontinued CREAD I and CREAD 2 (BN29552 and BN29553) Phase III studies of the investigational anti-beta-amyloid molecule crenezumab in people with early sporadic Alzheimer’s disease (AD). The decision was based on the results of a pre-planned interim analysis assessing the safety and efficacy of crenezumab conducted by the Independent Data Monitoring Committee, which indicated that crenezumab was unlikely to meet the primary endpoint of change from baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score. No safety signals for crenezumab were observed in this analysis and the overall safety profile was similar to that seen in previous trials.

“While the results with crenezumab are disappointing, they meaningfully contribute to our understanding of Alzheimer’s disease,” said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development at Roche. “We gratefully acknowledge the participants in the CREAD trials and the efforts of everyone involved in this important programme. We remain dedicated to the Alzheimer’s community and will continue our Phase III GRADUATE trials with gantenerumab and Phase II TAURIEL trial with the anti-tau molecule RG6100, as well as our imaging and fluid-based diagnostic solutions.”

CREAD 1 and 2 are two-year global, randomized, double-blind, placebo-controlled, Phase III studies testing the efficacy and safety of crenezumab in 1,500 people with early AD with confirmed cerebral beta amyloid pathology.

Crenezumab continues to be studied in the Alzheimer’s Prevention Initiative (API) trial investigating a different study population, namely cognitively healthy individuals in Colombia with an autosomal dominant mutation who are at risk to develop familial AD.