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Efficacy and Safety of DMB-I (INN: Latrepirdine) in Patients With Alzheimer Type Dementia
Sponsor: Bigespas LTD
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
Official title: 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
Key Details
Gender
All
Age Range
60 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
450
Start Date
2025-11-20
Completion Date
2027-05
Last Updated
2025-12-10
Healthy Volunteers
No
Conditions
Interventions
DMB-I (INN: Latrepirdine)
Active agent: Dimethylmethylpyridinylethyltetrahydrocarboline. Investigational drug in the study
Memantine Hydrochloride 20 MG
Memantine is used to treat moderate to severe Alzheimer's disease. Active comparator drug in the study
Placebo
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