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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\u2009+\u2009placebo, 30\u00a0mg\/day; DMB-I, 60\u00a0mg\/day and Placebo. Treatment efficacy was assessed using Alzheimer\u2019s 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\u00a0mg\/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\u00a0mg\/day dose was selected as optimal dose for further studies. Study retrospectively registered on Clinicaltrials.gov on February 27, 2024, NCT06292351.<\/jats:p>","DOI":"10.1038\/s41598-026-49538-4","type":"journal-article","created":{"date-parts":[[2026,5,15]],"date-time":"2026-05-15T09:01:39Z","timestamp":1778835699000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Efficacy and safety of DMB-I (latrepirdine) therapy in mild to moderate dementia in Alzheimer\u2019s disease: results of a multicenter, double-blind, randomized, placebo-controlled, clinical trial in three parallel groups"],"prefix":"10.1038","volume":"16","author":[{"given":"Boris I.","family":"Gorin","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stanislav O.","family":"Pozdnyakov","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ksenia A.","family":"Potapova","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elena A.","family":"Tukhovskaya","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dmitriy S.","family":"Gorchakov","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,5,15]]},"reference":[{"key":"49538_CR1","unstructured":"March (2025). https:\/\/www.who.int\/ru\/news-room\/fact-sheets\/detail\/dementia. 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Names, affiliations, addresses and chairpersons of Local Ethics Committees are listed below: Local Ethics Committee at Saint Petersburg State Healthcare Institution \u201cCity Hospital No. 40 of Kurortny District\u201d, 197706, Saint Petersburg, Sestroretsk, Borisova st., 9B, Russia (chairman - Dmitry A. Vologzhanin, lecgb40@mail.ru ); Local Ethics Committee of the LLC \u201cCenter for Evidence-Based Medicine\u201d, 150000, Yaroslavl, Bolshaya Oktyabrskaya st., 34, Office. 1 (chairman - Alena I. Belova, info@cdm.clinic); Local Ethics Committee of Sechenov First Moscow State Medical University of Ministry of Health of Russian Federation, 119435, Moscow, Abrikosovsky Lane, Building 1, Office 1 (\u0441hairman --Vladimir N. Nikolenko, iec@staff.sechenov.ru); Local Ethics Committee of Leningrad Regional State Healthcare Institution Psychoneurological Dispensary, 197183, St. Petersburg, Lev Tolstoy st., 19 (chairman - Alexander M. Panteleev, info@artemeda.com); Local Ethics Committee of \u201cFederal Center of Brain and Neurotechnologies\u201d of Federal Medical and Biological Agency of Russia, 117997, Moscow, Ostrovityanova st., 1\/10 (chairman - Olga I. Patsap, lek@fccps.ru); Independent Ethics Committee of Nova Vita Medical Center LLC, 344002, Rostov-on-Don, Temernitskaya st., 35\u00a0A (chairman - Elena V. Karpova); Local Ethics Committee of State Autonomous Healthcare Institution \u201cInterregional Clinical and Diagnostic Center\u201d, 420101, Republic of Tatarstan, Kazan, st. Karbysheva, 12a (chairman - Roman A. Bredikhin, icdc@icdc.ru).","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}}],"article-number":"14027"}}