Clinical Trial

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

Recruiting Phase 3
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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
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-11-18.
Trial Details
NCT Number NCT07251023
Lead Sponsor Bigespas LTD
Conditions Alzheimer Type Dementia
Enrollment 450 participants
Start Date 2025-11-20
Primary Completion 2027-05 (estimated)
Study Completion 2027-05 (estimated)
Updated on ClinicalTrials.gov 2025-12-10