drugset / Trial / NCT07251023

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

NCT07251023

Phase 3 Recruiting 450 enrolled Bigespas LTD
RandomizedParallel-groupDouble-blindTreatment

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

Timeline

Start
2025-11-20
Primary completion
2027-05
Completion
2027-05

Drugs

EvaluationDrugModalityDoseRoute
Subject DMB-I Unknown 10 mg
Comparator Memantine Unknown 20 mg

Indications