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.
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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.