Biotechnology company Biogen released clinical trial data it said represented a significant reduction in amyloid plaques in the brains of people affected by Alzheimer’s disease.
The findings were presented to the Alzheimer’s Association International Conference.
Biogen’s PRIME study is an ongoing Phase 1b randomized, double-blind, placebo-controlled, multiple-dose study evaluating the safety, tolerability and clinical effects of aducanumab in patients with mild Alzheimer’s disease.
Previously the researchers reported that the one, three, and 10 mg/kg dose showed the reduction of beta amyloid plaques and a slowing of clinical decline (compared to placebo) at 54 weeks.
The current analysis presented at the Alzheimer’s Association includes data from the 6 mg/kg dose against placebo.
In this analysis, patients with mild Alzheimer’s disease were treated for up to 54 weeks with a 6 mg/kg dose of aducanumab. The company says this dose passed the safety and tolerability test. The new findings were consistent with the early PRIME results.
Clinically too, the 6 mg/kg dose showed a decline in the symptoms of Alzheimer’s disease, especially cognitive decline. These were measured using the MMSE (Mini Mental State Examination) and Clinical Dementia Rating sum of boxes (CDR-SB) scales.
The company said it has already begun screening patients for the Phase 3 of PRIME clinical trials.