EXPEDITION3 enrolled over 2,100 patients diagnosed with mild dementia due to Alzheimer’s disease. It included an 18-month placebo-controlled period followed by an open-label extension. Patients in the solanezumab treatment arm did not exhibit a statistically significant slowing in cognitive decline compared to patients treated with placebo (P=0.095) as measured by the ADAS-Cog14 (Alzheimer’s Disease Assessment Scale-Cognitive subscale). Although the results from the study favored solanezumab, the magnitude of the treatment differences were small. The study did not indicate any new safety issues.
Eli Lilly has decided to not move forward with regulatory submissions for solanezumab for the treatment of mild dementia due to Alzheimer’s disease. The Company will work with investigators to close the open-label extensions for EXPEDITION, EXPEDITION2, and EXPEDITION3.
Solanezumab, a monoclonal antibody, was being investigated as a possible treatment for patients with mild cognitive impairment due to Alzheimer’s disease (EXPEDITION-PRO), preclinical
Alzheimer’s disease (Anti-Amyloid Treatment in Asymptomatic Alzheimer’s “A4”), ad Dominantly Inherited Alzheimer’s Disease (DIAN).
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