Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07251023
PHASE3

Efficacy and Safety of DMB-I (INN: Latrepirdine) in Patients With Alzheimer Type Dementia

Sponsor: Bigespas LTD

View on ClinicalTrials.gov

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

Interventions

DRUG

DMB-I (INN: Latrepirdine)

Active agent: Dimethylmethylpyridinylethyltetrahydrocarboline. Investigational drug in the study

DRUG

Memantine Hydrochloride 20 MG

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

DRUG

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