Alzheimer drug candidate NA‐831 for the treatment of Dementia caused by Covid‐19‐ A Phase 2/3 clinical trial methodology

Abstract

AbstractBackgroundMore than one third of Covid‐19 patients at the time of discharge from hospitalization have evidence of cognitive impairment and motor deficits. Patients surviving COVID‐19 are at high risk for subsequent development of neurological disease, particularly Alzheimer’s disease.MethodThe clinical Phase 2/3 evaluates the safety and efficacy of NA‐831 alone, and a combination therapy comprises NA‐831 with an anti‐viral drug Atazanavir, NA‐831 with an anti‐inflammatory drug, and a potential synergy between Atazanavir and Dexamethasone.The Clinical Protocol:Study Type: Interventional Phase 2/3Estimated Enrollment: 525 participantsAllocation: RandomizedThere will be daily symptom surveys for 14 days, then weekly thereafter for 3 weeks resulting in a total duration of follow up of 36 days.Status: is recruiting and the study is expected to be completed by December 15, 2023Result Primary Outcome Measures Time from randomization to recovery defined as1) absence of fever, as defined as at least 48 hours since last temperature ≥ 38.0°C without the use of fever‐reducing medications2) absence of symptoms of greater than mild severity for 24 hours3) not requiring supplemental oxygen beyond pre‐COVID baselineAND 4) freedom from mechanical ventilation or death Secondary Outcome Measures 1) Brief Cognitive Rating Scale (BCRS) and2) Clinician’s Interview‐Based Impression of Change plus caregiver input (CIBIC‐plus) after 24 weeks.ConclusionThe progress of the clinical trials will be presented discussed.