protocolSection identificationModule nctId: NCT06292351, orgStudyIdInfo id: DMBN_ALZH-2022-II, briefTitle: DMB-I in the Treatment of Alzheimer Type Dementia, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-27, primaryCompletionDateStruct date: 2024-12-21, completionDateStruct date: 2024-12-21, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Bigespas LTD, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to assess the efficacy and safety of DMB-I for the treatment of patients with Alzheimer type dementia., conditionsModule conditions: Alzheimer Disease, conditions: Dementia of Alzheimer Type, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 135, type: ESTIMATED, armsInterventionsModule interventions name: DMB-I (Dimebon), interventions name: Placebo, outcomesModule primaryOutcomes measure: Mean change in Alzheimer's Disease Assessment Scale score after 26 weeks of therapy (Visit 6) compared to baseline (Visit 0) in patients receiving the study drug or placebo, secondaryOutcomes measure: Mean change in cognitive impairment score on the Alzheimer's Disease Assessment Scale after 12 weeks of therapy compared to baseline, secondaryOutcomes measure: Mean change in Mini-Mental State Examination score after 12 weeks of therapy (Visit 4) and after 26 weeks of therapy (Visit 6) compared to baseline (Visit 0), secondaryOutcomes measure: Change in the quality of life of patients according to the Quality of Life - Alzheimer's Disease questionnaire after 12 weeks of therapy (Visit 4) and after 26 weeks of therapy (Visit 6) compared to baseline (Visit 1), secondaryOutcomes measure: Change in the general clinical impression in accordance with the Clinical Global Impressions Scale after 12 weeks of therapy (Visit 4) and after 26 weeks of therapy (Visit 6) compared to baseline (Visit 1), secondaryOutcomes measure: Dynamics on the Lawton's Instrumental activities of daily living scale after 12 weeks of therapy (Visit 4) and after 26 weeks of therapy (Visit 6) compared to baseline (Visit 1), eligibilityModule sex: ALL, minimumAge: 60 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: State autonomous healthcare institution "Transregional Clinical Diagnostic Center", status: RECRUITING, city: Kazan, zip: 420101, country: Russian Federation, contacts name: Dina Khasanova, role: CONTACT, email: Icdc@icdc.ru, geoPoint lat: 55.78874, lon: 49.12214, locations facility: Federal State Budgetary Institution "Federal center for brain and neurotechnologies" of the Federal Medical and Biological Agency (FSBI "FCBN" of Russia's FMBA), status: RECRUITING, city: Moscow, zip: 117997, country: Russian Federation, contacts name: Anna N. Bogolepova, role: CONTACT, email: annabogolepova@yandex.ru, geoPoint lat: 55.75222, lon: 37.61556, locations facility: Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University), status: RECRUITING, city: Moscow, zip: 119991, country: Russian Federation, contacts name: Marina A. Kinkulkina, role: CONTACT, email: Kinkulkina_m_a@staff.sechenov.ru, geoPoint lat: 55.75222, lon: 37.61556, locations facility: State public healthcare institution Leningrad regional psychoneurologic dispensary, status: RECRUITING, city: Roshchino, zip: 188820, country: Russian Federation, contacts name: Natalia A. Penchul, role: CONTACT, email: penchul@inbox.ru, geoPoint lat: 60.25191, lon: 29.6085, locations facility: "Medical Center Nova Vita", status: RECRUITING, city: Rostov-on-Don, zip: 344082, country: Russian Federation, contacts name: Dhaval Mavani, role: CONTACT, email: mavani_dhaval@yahoo.com, geoPoint lat: 47.23135, lon: 39.72328, locations facility: Saint Petersburg State budgetary healthcare institution "City Hospital № 40 of Kurortniy district", status: RECRUITING, city: Saint Petersburg, zip: 197706, country: Russian Federation, contacts name: Alina S Agaf'yina, role: CONTACT, email: a.agafina@mail.ru, geoPoint lat: 59.93863, lon: 30.31413, locations facility: "Centre of evidence-based medicine" LLC, status: RECRUITING, city: Yaroslavl, zip: 150000, country: Russian Federation, contacts name: Stanislav O. Pozdnyakov, role: CONTACT, email: sopozdnyakov@yandex.ru, geoPoint lat: 57.62987, lon: 39.87368, hasResults: False