Efficacy and safety of DMB-I (latrepirdine) therapy in mild to moderate dementia in Alzheimer's disease: results of a multicenter, double-blind, randomized, placebo-controlled, clinical trial in three parallel groups.

Alzheimer’s disease (AD) is one of leading dementia causes, affecting over 50 million people worldwide. A multicenter, double-blind, randomized, placebo-controlled clinical trial in three parallel groups was conducted to evaluate efficacy and safety of Latrepirdine polymorph DMB-I in 26-week treatment of dementia in patients with AD. 135 patients of both sexes aged 60 to 90 years were randomized into three groups: DMB-I + placebo, 30 mg/day; DMB-I, 60 mg/day and Placebo. Treatment efficacy was assessed using Alzheimer’s disease Assessment Scale cognitive subscale (ADAS-cog), Mini-Mental State Examination (MMSE-2), quality of life questionnaire (QOL-AD), Clinical Global Impression scale (CGI) and Instrumental Activities of Daily Living score (IADL). Clinical parameters and adverse events (AEs) also assessed. The efficacy of DMB-I at a dose of 60 mg/day was demonstrated by assessing the primary efficacy criterion, namely, a significant change in the ADAS-cog score after 26 weeks of treatment compared with baseline. Severity of cognitive impairment dynamics on ADAS-cog, CGI and LADL scales was significantly improved in groups receiving DMB-I at both doses, compared with placebo. AEs overall incidence was similar between DMB-I and Placebo groups. 26-week therapy with DMB-I at both doses demonstrated efficacy and favorable safety profile. 60 mg/day dose was selected as optimal dose for further studies. Study retrospectively registered on Clinicaltrials.gov on February 27, 2024, NCT06292351.