On 4 June, Alzheon, Inc., a clinical-stage biopharmaceutical company focused on developing new medicines for neurodegenerative disorders such Alzheimer’s disease (AD), announced the dosing of the first participant in its new APOLLOE4 Phase III study. The study is a randomised, double-blind and placebo-controlled trial evaluating the efficacy and safety of ALZ-801 in people with early AD carrying two copies of the ε4 allele of the apolipoprotein E gene (APOE4/4 homozygotes).
The company received a USD 47 million grant from the US National Institute on Aging (NIA) to advance this Phase III study. Approximately 300 participants from US, Canada and Europe will receive either placebo or ALZ-801 twice daily for 78 weeks. The primary objective of the APOLLOE4 study is to measure the impact of ALZ-801 on cognition using the Alzheimer's Disease Assessment Scale – cognitive subscale (ADAS-cog). Secondary outcomes include assessments of function, ability to perform daily activities and neuropsychiatric symptoms.
