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On May 3, Eli Lilly and Company announced positive results of its study showing that Donanemab significantly slowed cognitive and functional decline in people with early symptomatic Alzheimer's disease.

In a press release issued the same day, the Alzheimer's Association said it, "enthusiastically welcomes the robustly positive topline data reported" by Eli Lilly on the TRAILBLAZER-ALZ2 Phase 3 clinical trial of Donanemab for the treatment of early symptomatic Alzheimer's disease."

"These Donanemab Phase 3 results are significant and further underscore the scientific evidence and personal benefit these types of treatments can have when people can get access to them" said Joanne Pike, DrPH, Alzheimer's Association president and CEO. "The Centers for Medicare & Medicaid Services' policy to block Medicare access to Food and Drug Administration (FDA)-approved Alzheimer's treatments is in stark contrast to scientific evidence, is unprecedented and must be reversed immediately."

The trial met all of its primary and secondary endpoints. Most encouragingly, the company reports that nearly half (47%) of the study participants taking Donanemab had no decline of cognition and function for one year (compared to 29% on placebo). Donanemab slowed clinical decline by 35% compared to placebo on the primary outcome measure, and resulted in 40% less decline in the ability to perform activities of daily living.

"These are the strongest phase 3 data for an Alzheimer's treatment to date," said Pike. "This further underscores the inflection point we are at for the Alzheimer's field. 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, Medicare stubbornly continues to block access for the people who could benefit."

For people in the earliest stages of Alzheimer's, these results suggest Donanemab will significantly change the course of the disease. Like the other treatments in its class already approved by the FDA, Aduhelm and Leqembi, these results indicate Donanemab gives people more time at or near their full abilities to participate in daily life, remain independent and make future health care decisions. Treatments that deliver these benefits are just as valuable as treatments that extend the lives of those with other diseases.

"Medicare beneficiaries living with Alzheimer's, a fatal disease, deserve the same immediate, full coverage under Medicare afforded to those with other diseases," said the Alzheimer's Association release. "As with other anti-amyloid treatments - in fact, every drug - this treatment has side effects. Patients living with a fatal disease should have the opportunity to talk with their doctors to develop a treatment plan that is right for them, including weighing the benefits and risks of approved therapies."

The results of this and other positive trials demonstrate the importance of an early and accurate diagnosis on treatment and health outcomes.

"As we reflect on the importance of the positive results announced today, the Alzheimer's Association remains committed to advancing all potential treatment avenues and exploring methods for combining diverse approaches into combination therapies," stated the release. "There must be access to any approved treatments, as well as quality care and support for all people."