Efficacy and Safety of DMB-I (INN: Latrepirdine) in Patients With Alzheimer Type Dementia

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.