The program demonstrated the clinical effectiveness and good tolerability of Miladean (memantine+melatonin) in routine practice for patients with mild cognitive impairment.
Treatment with Miladean (memantine+melatonin) resulted in a 66% reduction in total cognitive impairment score after 8 weeks.
Miladean treatment was associated with significant reductions in impairments across multiple cognitive domains.
Sleep disturbance scores decreased significantly following 8 weeks of Miladean treatment.
High levels of treatment satisfaction were reported by both physicians and patients.
The study was a prospective non-interventional program conducted in real clinical practice settings across Russia.
This research suggests that a combination drug called Miladean, which contains memantine and melatonin, may be effective for people experiencing mild cognitive impairment (MCI) — a condition involving noticeable but not severe difficulties with memory, attention, and other thinking skills. In a large observational study involving nearly 500 patients across 36 Russian regions, people who took Miladean for 8 weeks showed a 66% average reduction in overall cognitive impairment scores. Improvements were seen across a wide range of cognitive abilities including memory, attention, executive function, processing speed, speech, visuospatial skills, and motor skills. The study also found notable improvements in sleep quality, with sleep disturbance scores dropping significantly and patients reporting about 42% better sleep quality on a standardized scale. This is noteworthy because the melatonin component of the drug is known to influence sleep regulation. Both doctors and patients expressed high satisfaction with the treatment, with 94% of physicians and 97% of patients reporting full or near-complete satisfaction. This research suggests that the combination of memantine and melatonin in a single medication may offer benefits for both cognitive symptoms and sleep problems in people with mild cognitive impairment in everyday clinical settings. However, because this was a non-interventional observational study without a placebo control group, it is not possible to rule out a placebo effect or other factors contributing to the improvements observed. Larger controlled trials would be needed to confirm these findings.
Levin O, Vasenina E, Beniashvili A, Morozova M. (2026). [New Opportunities in the Treatment of Moderate Cognitive Impairment: Results of the Millennium Study in Real Clinical Practice].. Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova. https://doi.org/10.17116/jnevro2025125121106