Understanding Donanemab’s Clinical Relevance for Patients With Alzheimer Disease: Alireza Atri

“We’re in a great era, a hopeful era, but we’re at the end of the beginning. We’ve got a lot of work to do to translate these things, understand them. We understand they’re foundational, they’re not curative by any means. Part of this is that the measures we use in clinical trials are not medically understandable to even more trialists because we don’t use them in clinical practice.”
Over the years, there has been an increased interest in the outcomes of randomized controlled trials assessing agents for early-stage mild cognitive impairment (MCI) or mild dementia due to Alzheimer disease (AD). Following the controversial approval of aducanumab (Aduhelm; Biogen) in 2021, many in the field pleaded for more transparency among industry leaders with the presentation of data for potential therapies and the effects they demonstrate.

Earlier this year, Eli Lilly received a complete response letter from the FDA regarding donanemab, its investigational antiamyloid therapy, and the need for more longterm data before granting approval. In the phase 3 TRAILBLAZER-ALZ-2 study (NCT04437511), a confirmatory study, donanemab substantially slowed the rate of decline by 22% to 36% on both the integrated Alzheimer Disease Rating Scale (iADRS) and Clinical Dementia Rating Scale-sum of boxes (CDR-SB), respectively, after 76 weeks of treatment. Furthermore, donanemab significantly slowed progression of more widespread deficits in iADL such as performing hobbies, using appliances, and being left at home, and on multi-domain cognitive impairments of orientation and language.

At the 2023 Clinical Trials on Alzheimer’s Disease conference, held October 24 to 27, in Boston, Massachusetts, expert Alireza Atri, , gave a talk on the clinical relevance of donanemab and its effects seen on clinical outcomes. Atri, director of the Banner Sun Health Research Institute, sat down with NeurologyLive® following his presentation to give an overview of what he discussed and why translating the effects of potential therapies to patients is critical. In addition, he spoke on the day-to-day improvements patients in the study experienced while on donanemab and how they impact overall quality of life.

1. Sims JR, Zimmer JA, Evans CD, et al. Donanemab in early symptomatic Alzheimer disease: the TRAILBLAZER-ALZ 2 randomized clinical trial. JAMA. Published online July 17, 2023. doi:10.1001/jama.2023.13239

Source: www.neurologylive.com

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