June 10, 2021 – LSU Health Shreveport neurologists will be participating in the ICARE AD study to monitor the safety and efficacy of the drug ADUHELM which received accelerated approval by the FDA on June 7. ADUHELM is the first new drug in twenty years for the treatment of Alzheimer’s. The drug will be made available to any patient that qualifies and is covered by insurance at a cost of $56K a year.
The accelerated approval has been granted based on data from clinical trials demonstrating the effect of ADUHELM on reducing amyloid beta plaques, a biomarker that is reasonably likely to predict clinical benefit, in this case a reduction in clinical decline. However, the FDA mandated that a follow up study be conducted to monitor post release safety and efficacy. Continued approval for ADUHELM’s indication as a treatment for Alzheimer’s disease is likely contingent upon verification of clinical benefit in confirmatory trial(s). Treatment involves monthly infusions.
The efficacy of ADUHELM was evaluated in two Phase 3 clinical trials—EMERGE (Study 1) and ENGAGE (Study 2)—in patients with early stages of Alzheimer’s disease (mild cognitive impairment and mild dementia) with confirmed presence of amyloid pathology. The effects of ADUHELM were also assessed in the double-blind, randomized, placebo-controlled, dose-ranging Phase 1b study, PRIME (Study 3). In these studies, ADUHELM consistently showed a dose- and time-dependent effect on the lowering of amyloid beta plaques (by 59 percent [p<0.0001] in ENGAGE, 71 percent [p<0.0001] in EMERGE, and 61 percent [p<0.0001] in PRIME). For more information on ADULEM, visit https://investors.biogen.com/news-releases/news-release-details/fda-grants-accelerated-approval-aduhelmtm-first-and-only.
LSU Health Shreveport neurologists are also participating in the New IDEAS (Imaging Dementia – Evidence for Amyloid Scanning) study sponsored through the Alzheimer’s Association and the Centers for Medicare and Medicaid to assess the utility of cerebral PET imaging in dementia patients to determine which are most likely to respond to newer agents such as ADUHELM. If you are interested in participating in this study, please have your referring physician register you at https://app.ideas-study.org/