Efficacy and safety of DMB‑I in mild‑to‑moderate Alzheimer’s disease

As a contract research organization (CRO), we have successfully completed a multicenter, double-blind, randomized, placebo-controlled Phase II study of the drug DMB‑I (latrepirdine) in patients with mild to moderate dementia due to Alzheimer’s disease. The study included patients aged 60–90 years who were receiving standard maintenance therapy with memantine, which allowed for an objective assessment of the additional contribution of DMB‑I to improving cognitive function and overall clinical status. After 26 weeks of treatment, DMB‑I at a dose of 60 mg/day demonstrated statistically significant efficacy compared with placebo based on validated scales (primarily ADAS‑cog), as well as a favorable safety profile with no severe or life-threatening adverse events. The results obtained confirm the potential of DMB‑I as a promising option in the treatment of dementia due to Alzheimer’s disease and provide a basis for conducting further larger-scale clinical trials (https://www.nature.com/articles/s41598-026-49538-4)