NCT07251023

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

Multicenter Randomized Double-blind Placebo-controlled Active Comparator-controlled Study to Assess the Efficacy and Safety of DMB-I (Dimebon®, INN: Latrepirdine) in Patients With Dementia Associated With Alzheimer's Disease

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Bigespas LTD · Industry
• Sex: All
• Age: 60 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Alzheimer Type Dementia

Interventions

Type	Name	Description
DRUG	DMB-I (INN: Latrepirdine)	Active agent: Dimethylmethylpyridinylethyltetrahydrocarboline. Investigational drug in the study
DRUG	Memantine Hydrochloride 20 MG	Memantine is used to treat moderate to severe Alzheimer's disease. Active comparator drug in the study
DRUG	Placebo	Placebo comparator (dummy) in the study.

Timeline

• Start date: 2025-11-20
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2025-11-26
• Last updated: 2025-12-10

Locations

12 sites across 1 country: Russia