The benefits and risks of Eli Lilly’s treatment for Alzheimer’s disease were confirmed in detailed scientific disclosures Monday, paving the way for its full approval but leaving physicians with lingering questions about the medicine’s impact on patients as a new era in Alzheimer’s therapy unfolds.
The drug, called donanemab, showed a 35% slowing of Alzheimer’s disease progression relative to placebo in a clinical trial that enrolled 1,700 patients with early-stage disease. Numerically, that’s a modest, 3.3-point improvement on a 144-point survey, called the Integrated Alzheimer’s Disease Rating Scale, or iADRS, that combines measures of cognition and function, such as driving, managing finances, or carrying on conversations.
There was a similar benefit when donanemab’s efficacy was assessed using a more common measure of cognition called the Clinical Dementia Rating-Sum of Boxes, or CDR-SB. On that scale, the Lilly drug showed a 36% slowing of cognitive decline relative to placebo, or 0.68 points on an 18-point scale.