Biogen/Eisai highlights details for Phase 4 Aduhelm study in Alzheimer's disease
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Biogen (NASDAQ:BIIB) and Eisai (OTCPK:ESALF) announce additional details about the Phase 4 confirmatory study, ENVISION, of Aduhelm (aducanumab-avwa) 100 mg/mL injection for intravenous use in early Alzheimerâs disease (AD).
The primary endpoint for ENVISION trial will be measured by the Clinical Dementia RatingâSum of Boxes (CDR-SB) at 18 months after treatment initiation with Aduhelm.

Biogen aims to enroll 18% of U.S. participants in the study from Black/African American and Latinx populations.
The update also includes an increase in the previously announced enrollment, from 1,300 to 1,500 people with early AD.
Secondary endpoints include AD Assessment Scale-Cognitive Subscale (ADAS-Cog 13), AD Cooperative Study - Activities of Daily Living Inventory - Mild Cognitive Impairment Version (ADCS-ADL-MCI), Integrated AD Rating Scale (iADRS), Mini-Mental State Examination (MMSE) and Neuropsychiatric Inventory (NPI-10).
The initiation of patient screening for ENVISION is planned for May 2022. The primary completion date is expected to be approximately four years after the study begins.
Previously, in July 2021, the companies set another diversity goal in the observational Phase 4 ICARE AD trial, which aims to enroll a total of approx. 6,000 patients.