RecruitingPhase 3NCT07251023

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

Sponsor

Bigespas LTD

Enrollment

450 participants

Start Date

Nov 20, 2025

Study Type

INTERVENTIONAL

Conditions

Alzheimer Type Dementia

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

Eligibility

Min Age: 60 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study tests a drug called latrepirdine (DMB-I) in older patients with mild to moderate Alzheimer's disease, to see if it can improve or slow the decline in memory and thinking. Some participants are already on standard Alzheimer's medication (memantine) and some are not. **You may be eligible if...** - You are between 60 and 90 years old - You have mild to moderate Alzheimer's disease - Your thinking and memory scores fall within a specific range on standard tests - You have a caregiver who can attend visits with you and monitor your medication - You are either already on a stable dose of memantine for at least 2 months, or not on any Alzheimer's medications **You may NOT be eligible if...** - You have another cause of dementia (such as vascular dementia, brain tumor, or infection) - You have Parkinson's disease, multiple sclerosis, or epilepsy - You have had a stroke - You have active cancer - You have significant heart, kidney, or liver disease - You smoke or have had alcohol or drug problems in the past 6 months - You have moderate-to-severe depression - You are taking certain medications that affect thinking (such as antipsychotics, benzodiazepines, or ginkgo biloba) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDMB-I (INN: Latrepirdine)

Active agent: Dimethylmethylpyridinylethyltetrahydrocarboline. Investigational drug in the study

DRUGMemantine Hydrochloride 20 MG

Memantine is used to treat moderate to severe Alzheimer's disease. Active comparator drug in the study

DRUGPlacebo

Placebo comparator (dummy) in the study.

Locations(12)

State autonomous healthcare institution "Transregional Clinical Diagnostic Center"

Kazan', Russia

Moscow State budgetary healthcare institution "City Clinical Hospital named after V.M. Buyanov of the Moscow Healthcare Department"

Moscow, Russia

Federal State Budgetary Institution "Federal Center for Brain and Neurotechnology" of the Federal Medical and Biological Agency

Moscow, Russia

Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University)

Moscow, Russia

Nizhny Novgorod region State budgetary healthcare institution " Nizhny Novgorod Clinical Psychiatric Hospital No. 1"

Nizhny Novgorod, Russia

State budgetary healthcare institution "Leningrad Regional Mental Health Center"

Roshchino, Russia

"Medical Center Nova Vita" LLC

Rostov-on-Don, Russia

Saint Petersburg State budgetary healthcare institution "Psychiatric Hospital No. 1 named after P.P. Kashchenko"

Saint Petersburg, Russia

"Medical services" LLC

Saint Petersburg, Russia

Saint Petersburg State budgetary healthcare institution "Psychoneurologic dispensary № 5"

Saint Petersburg, Russia

"Sphera Med" LLC

Saint Petersburg, Russia

Saint Petersburg State budgetary healthcare institution "City Hospital No. 40 of Kurortniy district"

Saint Petersburg, Russia

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NCT07251023