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Alzheon announces the recruitment of the first participant with early AD in Phase II trial of ALZ-801

Tuesday 27 October 2020

On 27 October, Alzheon Inc., a biopharmaceutical company focused on developing new medicines for people with Alzheimer's disease (AD) and other neurological disorders announced the initiation of a Phase II study evaluating biomarker effects of ALZ-801 in early AD.

Research participants with early AD who carry one or two copies of the ε4 allele of the apolipoprotein E (APOE4) gene will receive an oral tablet of ALZ-801, administered twice daily for two years. The Phase II study is aiming to access the effects of ALZ-801 on fluid and imaging biomarkers shown to be sensitive early markers of AD progression. The study will include a battery of biomarkers that reflect amyloid and tau pathology and neuronal injury.

Recently, the company received a USD 47 million grant from the US National Institute on Aging (NIA) to advance a Phase III study of ALZ-801 in APOE4/4 homozygous people with early AD. The trial is expected to start in Q1 2021.