nctId: NCT06292351 id: DMBN_ALZH-2022-II briefTitle: DMB-I in the Treatment of Alzheimer Type Dementia overallStatus: RECRUITING date: 2023-12-27 date: 2024-12-21 date: 2024-12-21 date: 2024-03-05 date: 2024-03-20 name: Bigespas LTD class: INDUSTRY 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. conditions: Alzheimer Disease conditions: Dementia of Alzheimer Type studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 135 type: ESTIMATED name: DMB-I (Dimebon) name: Placebo 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 measure: Mean change in cognitive impairment score on the Alzheimer's Disease Assessment Scale after 12 weeks of therapy compared to baseline 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) 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) 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) 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) sex: ALL minimumAge: 60 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: State autonomous healthcare institution "Transregional Clinical Diagnostic Center" status: RECRUITING city: Kazan zip: 420101 country: Russian Federation name: Dina Khasanova role: CONTACT email: Icdc@icdc.ru lat: 55.78874 lon: 49.12214 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 name: Anna N. Bogolepova role: CONTACT email: annabogolepova@yandex.ru lat: 55.75222 lon: 37.61556 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 name: Marina A. Kinkulkina role: CONTACT email: Kinkulkina_m_a@staff.sechenov.ru lat: 55.75222 lon: 37.61556 facility: State public healthcare institution Leningrad regional psychoneurologic dispensary status: RECRUITING city: Roshchino zip: 188820 country: Russian Federation name: Natalia A. Penchul role: CONTACT email: penchul@inbox.ru lat: 60.25191 lon: 29.6085 facility: "Medical Center Nova Vita" status: RECRUITING city: Rostov-on-Don zip: 344082 country: Russian Federation name: Dhaval Mavani role: CONTACT email: mavani_dhaval@yahoo.com lat: 47.23135 lon: 39.72328 facility: Saint Petersburg State budgetary healthcare institution "City Hospital № 40 of Kurortniy district" status: RECRUITING city: Saint Petersburg zip: 197706 country: Russian Federation name: Alina S Agaf'yina role: CONTACT email: a.agafina@mail.ru lat: 59.93863 lon: 30.31413 facility: "Centre of evidence-based medicine" LLC status: RECRUITING city: Yaroslavl zip: 150000 country: Russian Federation name: Stanislav O. Pozdnyakov role: CONTACT email: sopozdnyakov@yandex.ru lat: 57.62987 lon: 39.87368 hasResults: False