First patient dosed in APOLLOE4 phase III trial of oral ALZ 801 in patients with early Alzheimer’s disease.-Alzheon Inc.,

ALZ 801 is an oral treatment that has been shown in preclinical mechanistic studies to fully inhibit the formation of neurotoxic soluble beta amyloid oligomers at the Phase III clinical dose. APOLLOE4 is the only Phase III trial evaluating an oral anti-amyloid treatment and applying a precision medicine approach to disease-modification in D. The APOLLOE4 study is supported by a $47 million grant from the National Institute on Aging (NIA).

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 endpoints include assessments of function, ability to perform daily activities, and neuropsychiatric symptoms. The study will also evaluate ALZ 801’s effects on fluid and imaging biomarkers shown to be sensitive early markers of AD progression and neuroinflammation.

The APOLLOE4 randomized, double-blind, placebo-controlled trial will enroll 300 APOE4/4 homozygotes with Early AD at approximately 85 sites in the United States, Canada, and Europe. Recent findings from clinical trials with anti-amyloid agents provide strong evidence that soluble amyloid oligomers are neurotoxic upstream drivers of AD pathology, leading to progressive worsening in tau pathology and neuronal injury markers in cerebrospinal fluid (CSF) of AD patients..