The trial will also include a planned long-term extension to collect treatment data for up to 48 months. The primary endpoint for the trial will be measured by the Clinical Dementia Rating–Sum of Boxes (CDR-SB) at 18 months, as announced in January 2022.
The Phase 4 study will be a global, placebo-controlled trial, aiming to enroll around 1,500 patients with early Alzheimer’s disease and confirmation of amyloid beta pathology. However, the link between amyloid beta reduction and clinical improvement has been questioned (the European Medicines Agency, for example, said this link ‘has not been established’ when it rejected the drug’s application in December) In trials supporting the drug’s application for approval, patients receiving the treatment had significant dose-and time-dependent reduction of amyloid beta plaque, while patients in the control arm of the studies had no reduction of amyloid beta plaque (amyloid beta plaque being a hallmark of Alzheimer’s disease). Clinical benefitĪduhelm (aducanumab-avwa) represents the first new treatment approved for Alzheimer’s since 2003 and is the first therapy that targets the fundamental pathophysiology of the disease. It expects to start patient screening in May with the primary completion of the trial expected four years after the start of the study.
The drug was approved by the FDA in June, with the agency asking for a new randomized controlled clinical trial to verify the drug’s clinical benefit.īiogen has now submitted the final study protocol for the Phase 4 Envision trial to the FDA for review.