NCT06292351

DMB-I in the Treatment of Alzheimer Type Dementia

Multicenter Randomized Double-blind Placebo-controlled Three-arm Parallel-group Clinical Study to Evaluate the Efficacy and Safety of DMB-I in the Treatment of Dementia Associated With Alzheimer's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: Bigespas LTD · Industry
• Sex: All
• Age: 60 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy and safety of DMB-I for the treatment of patients with Alzheimer type dementia.

Detailed description

This is a multicenter, randomized, placebo-controlled study that is to assess efficacy and safety, to select the optimal therapeutic dose of the drug and to test the hypothesis of superiority of DMB-I (Dimebon) over placebo in patients with mild to moderate Alzheimer's disease. The study is planned to be conducted in clinical sites of the Russian Federation. Patients meeting all the eligibility criteria will be randomized into one of three treatment arms: 1. DMB-I (Dimebon) 1 tab + Placebo 1 tab 3 times a day. 2. DMB-I (Dimebon) 2 tab 3 times a day. 3. Placebo 2 tab 3 times a day. The total study duration for each patient is approximately 182 days broken down as follows: Screening period: up to 14 days, Treatment period: 26 weeks, Follow-up period: 2 weeks.

Conditions

• Alzheimer Disease
• Dementia of Alzheimer Type

Interventions

Type	Name	Description
DRUG	DMB-I (Dimebon)	20 mg 3 times a day, or 10 mg + 10 mg 3 times a day (for DMB-I + Placebo arm)
OTHER	Placebo	20 mg 3 times a day, or 10 mg + 10 mg 3 times a day (for DMB-I + Placebo arm)

Timeline

• Start date: 2023-12-27
• Primary completion: 2025-01-13
• Completion: 2025-01-31
• First posted: 2024-03-05
• Last updated: 2025-03-28

Locations

7 sites across 1 country: Russia