Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT06292351
Brief 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.
Study:
NCT06292351
Study Brief:
Protocol Section:
NCT06292351