At the 2014 Alzheimer’s Association International Conference, Roche presented data from two phase II studies investigating whether crenezumab can delay cognitive and functional decline in patients with mild to moderate Alzheimer’s disease.
Although the larger study, known as ABBY, did not meet its primary end points in patients with mild to moderate Alzheimer’s disease, it provided initial evidence of a treatment effect in patients with mild Alzheimer’s disease. Similar effects on clinical decline were observed in BLAZE, a smaller biomarker study.
In the ABBY study, crenezumab treatment in patients with mild to moderate Alzheimer’s disease tended to slow the decline of cognitive abilities, as measured by the 12-item cognitive subscale of the Alzheimer’s Disease Assessment Scale (ADAS-cog12), but had no effect on global functioning, as measured by Clinical Dementia Rating-Sum of Boxes. These outcomes were the study’s primary end points. In an exploratory analysis of patients with milder disease treated with IV crenezumab, the researchers observed a positive trend toward greater reduction in cognitive decline in progressively milder subsets of patients, relative to placebo.
In the BLAZE study, which enrolled people who tested positive for an amyloid imaging biomarker, the primary end point was a change in brain amyloid load. In a secondary end point analysis, treatment with IV crenezumab was associated with a trend toward slowing cognitive decline in patients with mild disease (as measured by ADAS-cog12). Biomarker results from the ABBY and BLAZE studies will be presented at an upcoming meeting.
“Data from these phase II studies provide valuable information about crenezumab’s potential clinical activity in people with Alzheimer’s disease, where there is a great need for treatment options,” said Richard Scheller, PhD, Executive Vice President and Head of Genentech Research and Early Development. “These findings support the importance of testing potential disease-modifying agents, such as beta-amyloid antibodies, early in the course of the disease.”