Donanemab slows cognitive, functional decline in early Alzheimer’s
Click Here to Manage Email Alerts
Key takeaways:
- Eli Lilly & Co.’s donanemab slowed cognitive and functional decline in people with early Alzheimer’s.
- The phase 3 results support Lilly’s submission to the FDA.
Donanemab slowed cognitive and functional decline in early Alzheimer’s disease, according to the results of a phase 3 study.
The randomized, double-blind, placebo-controlled TRAILBLAZER-ALZ 2 study enrolled participants with early symptomatic AD. After 18 months, donanemab slowed cognitive decline by 35% (P < .0001) as measured by the integrated AD Rating Scale (iADRS). Donanemab also slowed functional decline by 36% (P < .0001) over 18 months as measured by the Clinical Dementia Rating-Sum of Boxes (CDR-SB), according to a press release from Eli Lilly & Co.
Secondary analyses revealed that 47% of participants using donanemab compared with 29% of participants on placebo had no functional decline at 1 year (P < .001). Further, donanemab lowered the risk for disease progression by 39% compared with placebo, according to the release.
Among 552 participants with higher baseline levels of tau and 1,726 participants with intermediate baseline tau levels, the CDR-SB demonstrated a 29% slowing of functional decline and the iADRS demonstrated a 22% slowing of cognitive decline.
“Over the last 20 years, Lilly scientists have blazed new trails in the fight against Alzheimer’s disease by elucidating basic mechanisms of AD pathology and discovering imaging and blood biomarker tools to track the pathology,” Daniel Skovronsky, MD, PhD, chief scientific and medical officer of Lilly and president of Lilly Research Laboratories, said in the release. “We are extremely pleased that donanemab yielded positive clinical results with compelling statistical significance for people with Alzheimer’s disease in this trial. This is the first phase 3 trial of any investigational medicine for Alzheimer’s disease to deliver 35% slowing of clinical and functional decline.”
Lilly plans to pursue global regulatory submissions and anticipates submitting to the FDA this quarter.
Perspective
Back to Top
The trial met all of its primary and secondary endpoints, and notably, nearly half of the participants on donanemab had no clinical progression of the disease for 1 year. This means that, for people in the earliest stages of Alzheimer’s, donanemab can significantly change the course of the disease, allowing people more time at or near their full abilities to participate in daily life, remain independent and make future health care decisions.
These data further underscore the scientific validity of this pathway, as well as the personal benefit this type of treatment can have when people can get access to it. The progress we’ve seen in this class of treatments, as well as the diversification of potential new therapies over the past few years, provides hope to those impacted by this devastating disease. Yet, the CMS policy to block Medicare access to FDA-approved Alzheimer’s treatments is in stark contrast to what we’re seeing in the science. It is unprecedented and must be reversed immediately.
Read more about
Click Here to Manage Email Alerts