Alzheimer’s Therapy Elenbecestat Reduces Brain Amyloid Levels, is Safe and Well-Tolerated, Trial Shows

Alzheimer’s Therapy Elenbecestat Reduces Brain Amyloid Levels, is Safe and Well-Tolerated, Trial Shows
Treatment with the investigational compound elenbecestat reduced brain amyloid beta levels and was safe and well-tolerated, according to Phase 2 clinical trial results. The presence of amyloid beta plaques is a major characteristic of the brains of Alzheimer’s disease patients. Amyloid beta is produced through the work of a key enzyme called BACE (beta-amyloid cleaving enzyme). Elenbecestat is an oral inhibitor of BACE being developed by by Eisai and Biogen. The multicenter randomized, double-blind Phase 2 trial (NCT02322021), also known as Study 202, is assessing elenbecestat in patients with mild cognitive impairment (MCI) due to Alzheimer’s, or with mild-to-moderate dementia also due to Alzheimer’s, with amyloid beta buildup confirmed by positron emission tomography (PET) imaging. Seventy patients were enrolled and randomized to one of four groups receiving either 5, 15, or 50 mg of daily elenbecestat, or placebo. More than half of the patients who received 5 and 15 mg of elenbecestat switched to 50 mg for three months or more, representing a total of 38 subjects taking the higher therapeutic dose for a mean duration of nearly 11 months. Patients receiving 50 mg elenbecestat showed a significant decrease in brain amyloid beta level over 18 months in comparison to placebo. Cognitive function assessed with CDR-SB (
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