AZTherapies completes enrolment in ALZT-OP1 Phase II trial for early AD

01/08/2019

On 1 August, AZTherapies, a clinical-stage biopharmaceutical company developing novel therapies to change neurodegenerative disease progression, announced that it has completed the recruitment of its COGNITE Phase III clinical trial evaluating the safety, tolerability and efficacy of ALZT-OP1 for the treatment of early Alzheimer’s disease (AD). The COGNITE study is a global, randomised, double-blinded and placebo-controlled Phase III study designed to determine if ALZT-OP1 will slow down, arrests, or reverse cognitive and functional decline in people with early AD. The combination drug therapy ALZT-OP1 consists of the administration of two previously approved drugs, cromolyn (designated ALZT-OP1a) and ibuprofen (designated ALZT-OP1b) that have been re-engineered to suppress the brain’s neuroinflammatory response. The company, which announced the initiation of the study in September 2015 across US, Australia and European sites, reported that approximately 1,800 people aged 55-79 were screened by cognition, function and levels of biomarkers in cerebrospinal fluid to enrol a total of 620 participants. The study completion is expected in the fourth quarter of 2020.

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