Phase 3 Studies Fail to Show Benefit of Drugs in Alzheimer's
(HealthDay News) – For patients with mild-to-moderate Alzheimer's disease, neither bapineuzumab nor solanezumab improves cognitive outcomes, according to two studies published in the Jan. 23 issue of the New England Journal of Medicine.
Stephen Salloway, MD, from the Butler Hospital in Providence, RI, and colleagues conducted two Phase 3 trials involving 1,121 carriers of the apolipoprotein E ε4 allele and 1,331 noncarriers, all with mild-to-moderate Alzheimer's disease and randomized to receive bapineuzumab or placebo. The researchers observed no significant between-group differences in the primary outcome of changes in the 11-item cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-cog11) or the Disability Assessment for Dementia scores among carriers (−0.2 [P=0.8] and −1.2 [P=0.34], respectively) and noncarriers (−0.3 [P=0.64] and 2.8 [P=0.07], respectively, for the 0.5mg/kg dose, and 0.4 [P=0.62] and 0.9 [P=0.55], respectively, for the 1-mg-per-kg dose).
Rachelle S. Doody, MD, PhD, from Baylor College of Medicine in Houston, and colleagues conducted two Phase 3 trials in which 1,012 and 1,040 patients with mild-to-moderate Alzheimer's disease were randomized to placebo or solanezumab every four weeks for 18 months. The researchers observed no significant improvement in the primary outcome (changes from baseline to Week 80 in scores on the ADAS-cog11), with a difference between the groups of −0.8 points (P=0.24) and −1.3 (P=0.06) in the two trials.
"Solanezumab, a humanized monoclonal antibody that binds amyloid, failed to improve cognition or functional ability," Doody and colleagues write.
The Salloway study was partially funded by Janssen Alzheimer Immunotherapy Research and Development and Pfizer; the Doody study was funded by Eli Lilly.