Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-27 @ 6:21 AM
Study NCT ID:
NCT06292351
Status:
COMPLETED
Last Update Posted:
2025-03-28
First Post:
2024-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DMB-I in the Treatment of Alzheimer Type Dementia
Sponsor:
Bigespas LTD
Organization:
Study Overview
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:
COMPLETED
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: