New Alzheimer's drug shown to slow cognitive decline by 35%

"Based on these results, Lilly will proceed with global regulatory submissions as quickly as possible and anticipates making a submission to the U.S. Food and Drug Administration (FDA)...this quarter," the company said. "Lilly will work with the FDA and other global regulators to achieve the fastest path to traditional approvals."

The devastating effects of Alzheimer's disease on both patients and their families are well-documented, especially given how ineffective previous attempts to slow the progression of the disease have been. With this news, Alzheimer's sufferers and their families finally have some hope to slow the disease that once seemed as inevitable as it was unstoppable.

"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, M.D., Ph.D., Eli Lilly's chief scientific and medical officer, and president of Lilly Research Laboratories, said. "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."

Among trial participants, nearly half (47%) of those receiving donanemab experienced no measurable worsening of symptoms after one year (measured as no decline in the sum of boxes of the clinical dementia rating, or CDR-SB), compared to 29% of participants who were on placebo. It is also noted that participants receiving the drug had a 39% lower risk of progressing to the next stage of Alzheimer's disease compared to those on placebo,

"We are encouraged by the potential clinical benefits that donanemab may provide, although like many effective treatments for debilitating and fatal diseases, there are associated risks that may be serious and life-threatening," Mark Mintun, M.D., group vice president of Neuroscience Research & Development at Eli Lilly and president of Avid Radiopharmaceuticals, said. "We thank the participants in the clinical trial and their loved ones for their time and commitment to finding solutions for this disease."

Even advanced Alzheimer's disease patients may benefit

 While the most significant benefits demonstrated in the trial were for those participants in the early stages of the disease, a more limited number of advanced cases were also included in the study of donanemab, and here too there are encouraging results.

In intermediate and advanced Alzheimer's disease cases, participants show a 29% and 22% slower progression of symptoms, respectively, so even those who have already progressed significantly into the later stages of the disease stand to benefit from the new drug.

Cautious optimism

Given how little good news there has been in the fight against Alzheimer's disease, it is possible to overhype any progress toward a treatment. It must also be noted that this does not represent a cure for Alzheimer's disease and that even those who respond well to the new drug are likely to experience declining cognitive functions as the disease progresses, albeit at a slower pace than before.

"It's modest, but I think it's real," Dr. Ronald Petersen, an Alzheimer's researcher at Mayo Clinic, told Reuters about the new results, "and I think it's clinically meaningful."