Biogen Inc Aducanumab Phase 3 Topline Results Transcript
All right. Good morning. My name is Samantha Budd Haeberlein. And on behalf of my co-authors here, I would like to present the EMERGE and ENGAGE top line results. These were 2 identically designed Phase III studies to evaluate the effectiveness of aducanumab in patients with early Alzheimer's disease.
Here are the disclosure of the authors. And I would like to remind you that aducanumab is an investigational compound and is not yet approved in any country. The aducanumab Phase III studies called EMERGE and ENGAGE were 2 18-month randomized, double-blind, placebo-controlled Phase III studies. They recruited 3,285 patients in 348 sites in 20 countries. The population that was enrolled in these studies was patients with MCI due to Alzheimer's disease and patients with mild Alzheimer's disease dementia with a baseline MMSE of 24 to 30 inclusive and a CDR of 0.5. There were 2 dosing regimens that were tested, a low and a high dose, and these were randomized 1:1:1 with placebo. The primary end point was the CDR sum of boxes changed from
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