The goal of this clinical study is to learn if the study drug DMB-I (INN: Latrepirdine) works to treat Alzheimer type dementia in adults. It will also learn about the safety of DMB-I (INN: Latrepirdine). The main questions it aims to answer are: * Does DMB-I improve cognitive functions in patients with dementia associated with Alzheimer's disease, and how sigificant the improvement is? * What medical problems do participants have when taking DMB-I? Researchers will compare DMB-I to a placebo (a look-alike substance that contains no drug) to see if the study drug works to treat Alzheimer type dementia. * Is DMB-I effective and safe when taken long-term? Participants will: Take the study drug or a placebo (with or without Akatinol Memantine®) every day for 26 weeks at Stage 1 of the study, and take the study drug (with or without Akatinol Memantine®) every day for 26 weeks at Stage 2 of the study. Visit the clinic 13 times for checkups and tests Keep a diary of their symptoms
This is a multicenter randomized double-blind placebo-controlled two-stage study that is to assess efficacy and safety of DMB-I (INN: Latrepirdine) in patients with Alzheimer type dementia. The study is planned to be conducted in approximately 15 clinical sites of the Russian Federation. At Stage 1 (comparative stage, 26 weeks), the study will examine three treatment groups. Patients in Group 1 and Group 2 will receive Akatinol Memantine® in addition to the study therapy (DMB-I or Placebo). Patients in Group 3 will receive DMB-I alone. The study is double-blind for DMB-I and Placebo; Akatinol Memantine® will not be blinded. Patients meeting all the eligibility criteria will be randomized into one of three treatment groups: 1. DMB-I, 10 mg, 2 tablets 3 times daily + Akatinol Memantine®, 20 mg once daily - 175 patients (Group 1: DMB-I + Memantine). 2. Placebo, 2 tablets 3 times daily + Akatinol Memantine®, 20 mg once daily - 175 patients (Group 2: Placebo + Memantine). 3. DMB-I, 10 mg, 2 tablets 3 times daily - 100 patients (Group 3: DMB-I). Following completion of Stage 1, patients will continue participating in the open-label stage of the study (Stage 2) for additional 26 weeks to evaluate the long-term efficacy and safety of DMB-I. During this stage, patients in Group 1 (DMB-I + Memantine) will continue their study therapy unchanged. Patients in Group 2 (Placebo + Memantine) will discontinue Placebo and begin therapy with DMB-I (while continuing to take Akatinol Memantine®). Patients in Group 3 (DMB-I monotherapy) will also continue their therapy unchanged. The total study duration for each patient is approximately 56 weeks broken down as follows: Screening period: up to 2 weeks, Treatment period (Stage 1): 26 weeks, Treatment period (Stage 2): 26 weeks, Follow-up period: 2 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
450
Active agent: Dimethylmethylpyridinylethyltetrahydrocarboline. Investigational drug in the study
Memantine is used to treat moderate to severe Alzheimer's disease. Active comparator drug in the study
Placebo comparator (dummy) in the study.
State autonomous healthcare institution "Transregional Clinical Diagnostic Center"
Kazan', Russia
RECRUITINGMoscow State budgetary healthcare institution "City Clinical Hospital named after V.M. Buyanov of the Moscow Healthcare Department"
Moscow, Russia
RECRUITINGFederal State Budgetary Institution "Federal Center for Brain and Neurotechnology" of the Federal Medical and Biological Agency
Moscow, Russia
RECRUITINGFederal 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)
Moscow, Russia
RECRUITINGNizhny Novgorod region State budgetary healthcare institution " Nizhny Novgorod Clinical Psychiatric Hospital No. 1"
Nizhny Novgorod, Russia
RECRUITINGState budgetary healthcare institution "Leningrad Regional Mental Health Center"
Roshchino, Russia
RECRUITING"Medical Center Nova Vita" LLC
Rostov-on-Don, Russia
RECRUITINGSaint Petersburg State budgetary healthcare institution "Psychiatric Hospital No. 1 named after P.P. Kashchenko"
Saint Petersburg, Russia
RECRUITING"Medical services" LLC
Saint Petersburg, Russia
RECRUITINGSaint Petersburg State budgetary healthcare institution "Psychoneurologic dispensary № 5"
Saint Petersburg, Russia
RECRUITING...and 2 more locations
Assessment of the change in ADAS-Cog Scale overall score at Week 26 compared to baseline (Week 0) in patients receiving DMB-I (Group 1) Vs. patients receiving placebo (Group 2)
ADAS-Cog Scale consists of 12 questions. The scale's minimum score - 0, maximum score - 88, where the higher score means the worse outcome
Time frame: Baseline (Week 0) Vs. Week 26
Assessment of the change in ADAS-Cog Scale overall score at Week 26 compared to baseline (Week 0) in patients receiving DMB-I (Group 3) Vs. patients receiving placebo (Group 2)
ADAS-Cog Scale consists of 12 questions. The scale's minimum score - 0, maximum score - 88, where the higher score means the worse outcome
Time frame: Baseline (Week 0) Vs. Week 26
Change in ADAS-Cog Scale overall score at Week 4, Week 12, Week 26, Week 30, Week 38, and Week 52 compared to baseline (Week 0) across all treatment groups
ADAS-Cog Scale consists of 12 questions. The scale's minimum score - 0, maximum score - 88, where the higher score means the worse outcome
Time frame: Baseline (Week 0) Vs. Week 4, Week 12, Week 26, Week 30, Week 38, Week 52
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