A novel drug is showing promise for helping improve cognition in patients with mild to moderate Alzheimer's disease (AD), according to new topline results.
A phase 3 trial of more than 800 patients showed that those who were randomly assigned to receive oral GV-971 (Green Valley Pharmaceutical Co, China) met the primary endpoint of significant change from baseline to week 36 on the 12-item cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog 12) compared with those who received placebo.
"GV-971 is a novel, marine-derived oligosaccharide, which has multi-targeting mechanisms, including inhibition of amyloid-β fibril formation, neuroinflammation, and recondition of dysbiosis of gut microbiota," Meiyu Geng, PhD, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, said in a news release from the manufacturer.
"We are encouraged by our findings from this phase 3 clinical trial," added Geng.
The topline results were released at the 11th Clinical Trials on Alzheimer's Disease Conference in Barcelona, Spain.
In the double-blind, placebo-controlled trial, 818 patients across 34 sites in China were randomly assigned to receive oral GV-971 450 mg twice per day or matching placebo for 36 weeks. Participants (aged 50 to 85 years) met clinical criteria for mild to moderate AD and had scores of 11 to 26 on the Mini–Mental State Examination (MMSE).