#AAIC21 – Aduhelm Shows Range of Benefits in EMERGE
Treatment with Aduhelm (aducanumab) slows the clinical decline observed in in Alzheimer’s across a range of cognitive and functional measurements, according to a new analysis of data from a Phase 3 clinical trial.
The results were presented at the Alzheimer’s Association International Conference (AAIC) 2021, held July 26–30 both virtually and in Denver, Colorado. The poster was titled, “Item-level analysis of clinical measures in patients with early symptomatic Alzheimer’s disease following treatment with high-dose aducanumab in the Phase 3 study EMERGE.”
Aduhelm, developed by Biogen and Eisai, recently was granted accelerated approval by the U.S. Food and Drug Administration (FDA) as a treatment for mild cognitive impairment (MCI) and early Alzheimer’s. The accelerated approval was based on early clinical trial data that showed Aduhelm treatment could reduce levels of amyloid plaques, which are abnormal protein deposits that occur in the brains of Alzheimer’s patients.
At AAIC, researchers from Biogen and other institutions presented a new analysis from a Phase 3 clinical trial called EMERGE (NCT02484547), which enrolled 1,643 participants with MCI or early Alzhiemer’s.
Previously released results from EMERGE showed that the treatment significantly reduced — by 22% — the decline in participants’ cognitive and functional abilities, as measured with the Clinical Dementia Rating scale Sum of Boxes (CDR-SB). Of note, an identically designed trial called ENGAGE (NCT02477800) showed no such benefit.
In the new analysis, researchers looked at the effect of treatment on individual components of the Clinical Dementia Rating-Sum of Boxes (CDR-SB). This standardized assessment measures cognition and function across six domains: memory; orientation; judgment and problem solving; community affairs; home and hobbies; and personal care.
The analysis showed that, after 78 weeks, participants on the now-approved dose (10 mg/kg) of Aduhelm had markedly slower decline across all six measurements, compared to those on a placebo. The average treatment effect ranged from 15% for personal care, to 28% for memory.
Analyses of another standardized assessment, called the Alzheimer’s Disease Assessment Scale – Cognitive Subscale (ADAS-Cog13), showed that patients treated with Aduhelm experienced a slower decline in certain cognitive abilities, like the ability to recognize and recall words, which typically shows impairment early on in the course of Alzheimer’s.
Results from another standardized measurement — the Alzheimer’s Disease Cooperative Study-Activities of Daily Living Inventory, Mild Cognitive Impairment version (ADCS-ADL-MCI) — indicated the treatment slowed the decline in a variety of factors related to daily living.
The treatment also appeared to slow the decline of certain psychiatric and behavioral issues commonly associated with Alzheimer’s, such as depression, aggression, and anxiety, based on data from the Neuropsychiatric Inventory-10 (NPI-10), which also was reflected in a decrease of caregiver distress.
Overall, “The results demonstrate the consistency of the aducanumab treatment effect in slowing decline across cognitive, functional, and behavioral domains in early Alzheimer’s disease,” the researchers concluded.