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

NCT07251023 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2025-12-10

No results posted yet for this study

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

Conditions

  • Alzheimer Type Dementia

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.

Sponsors & Collaborators

  • Bigespas LTD

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-20
Primary Completion
2027-05-31
Completion
2027-05-31

Countries

  • Russia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07251023 on ClinicalTrials.gov