DMB-I in the Treatment of Alzheimer Type Dementia

Alzheimer Disease Clinical Trial

Official title: 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 Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia
• Dementia of Alzheimer Type

• NCT number: NCT06292351
• Study type: Interventional
• Source: Bigespas LTD
• Contact: Yana Shabalina
• Phone: +7 4952761143
• Email: yashab@ipharma.ru
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: December 27, 2023
• Completion date: December 21, 2024