Cambridge, MA, Jan 28, 2022 – (JCN Newswire) – Biogen Inc. and Eisai Co., Ltd. (Tokyo, Japan) today announced additional details about the Phase 4 post-marketing confirmatory study, ENVISION, of ADUHELM (aducanumab- avwa) 100 mg/mL injection for intravenous use in early Alzheimer’s disease, including details of the study’s goal for diverse enrollment and primary endpoint.
Biogen aims to enroll 18 percent of US participants in ENVISION from Black/African American and Latinx populations. This goal is reflective of Biogen’s ongoing commitment to increase diversity in clinical trials.
“Historically, patients from diverse backgrounds have been poorly represented in Alzheimer’s disease clinical trials, and we are committed to changing this,” said Priya Singhal MD, MPH, Head of Global Safety & Regulatory Sciences and interim Head of Research & Development at Biogen. “This goal matches the diversity among Americans diagnosed with early Alzheimer’s disease, while at the same time, the trial will generate substantial data to verify the effectiveness of ADUHELM.”
Biogen will implement multiple strategies to help overcome barriers to diverse patient enrollment in Alzheimer’s disease trials, such as, lack of access to medical centers, familiarity with benefit/risk profile of treatment, and financial or logistical burdens.
“It’s important to see this ambitious focus on diversity being prioritized in enrollment and integrated as a key part of the ENVISION clinical trial, so that we can have data from patients who more closely represent what we see in the clinic,” said Dylan Wint, MD, Cleveland Clinic Lou Ruvo Center for Brain Health, Nevada.
The companies also announced today that the primary endpoint for the global, placebo-controlled ENVISION trial will be measured by the Clinical Dementia Rating Sum of Boxes (CDR-SB) at 18 months after treatment initiation with ADUHELM. The CDR-SB endpoint is a validated measure of both cognition and function that is widely used in clinical trials of patients with early symptomatic Alzheimer’s disease, is consistent with ADUHELM’s Phase 3 EMERGE and ENGAGE studies, and capable of generating robust outcomes. The update also includes an increase in the previously announced enrollment, from 1,300 to 1,500 people with early Alzheimer’s disease (Mild Cognitive Impairment due to Alzheimer’s disease and mild Alzheimer’s disease), with confirmation of amyloid beta pathology, to further strengthen the data provided by the study.
Although ENVISION and other ADUHELM clinical trials are already planned or underway, the Centers for Medicare and Medicaid Services (CMS) recently released a draft National Coverage Determination (NCD), which would restrict Medicare coverage of ADUHELM and other amyloid-targeting therapies to patients enrolled in additional clinical trials. Biogen is committed to engaging with CMS to avoid unnecessary duplication of clinical trials and work towards finding a path to offer immediate access to patients to the first FDA approved treatment for Alzheimer’s disease since 2003.
In addition to the primary endpoint, CDR-SB, secondary endpoints include Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog 13), Alzheimer’s Disease Cooperative Study – Activities of Daily Living Inventory – Mild Cognitive Impairment Version (ADCS-ADL-MCI) , Integrated Alzheimer’s Disease 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. Based on enrollment rates …