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DMB-I in the Treatment of Alzheimer Type Dementia | Clinical Trials | Clareo Health

COMPLETEDPHASE2

DMB-I in the Treatment of Alzheimer Type Dementia

Multicenter Randomized Double-blind Placebo-controlled Three-arm Parallel-group Clinical Study to Evaluate the Efficacy and Safety of DMB-I in the Treatment of Dementia Associated With Alzheimer's Disease

NCT06292351•Bigespas LTD

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the efficacy and safety of DMB-I for the treatment of patients with Alzheimer type dementia.

Detailed Description

This is a multicenter, randomized, placebo-controlled study that is to assess efficacy and safety, to select the optimal therapeutic dose of the drug and to test the hypothesis of superiority of DMB-I (Dimebon) over placebo in patients with mild to moderate Alzheimer's disease. The study is planned to be conducted in clinical sites of the Russian Federation. Patients meeting all the eligibility criteria will be randomized into one of three treatment arms: 1. DMB-I (Dimebon) 1 tab + Placebo 1 tab 3 times a day. 2. DMB-I (Dimebon) 2 tab 3 times a day. 3. Placebo 2 tab 3 times a day. The total study duration for each patient is approximately 182 days broken down as follows: Screening period: up to 14 days, Treatment period: 26 weeks, Follow-up period: 2 weeks.

Eligibility

Age

60 - 90 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Informed consent to participate in the study.
•2. Patients of any gender aged 60 to 90 years inclusive.
•3. Patients diagnosed with mild to moderate Alzheimer type dementia according to the NINCDS-ADRDA criteria, receiving basic treatment with memantine at a daily dose of 20 mg for at least 2 months.
•4. The MMSE score is in the range of 10-23 inclusive.
•5. No signs of dementia of vascular origin according to CT/MRI data. Repeated Acute Cerebrovascular Accidents (focal infarctions) in brain areas that are critical for cognitive functions and behavior are the mandatory neuroimaging signs of vascular dementia.
•6. The presence of a caregiver who is in contact with the patient a significant part of the time, agrees to accompany the patient to all visits, monitor the intake of the study drug and fill out the patient's diary.
•7. Patients who are able to undergo the tests provided for in the protocol.

Exclusion Criteria

•1. Patients diagnosed with other diseases that cause dementia (severe hypothyroidism, anemia, brain tumor, including a history of neuroinfections, etc.) according to medical history, medical documentation and the results of additional examination methods.
•2. History of other neurodegenerative diseases of the brain, Parkinson's disease, multiple sclerosis, demyelinating diseases of the nervous system, hereditary degenerative diseases of the central nervous system, abnormalities of the nervous system, uncontrolled epilepsy, hallucinations, other neurological disorders seriously affecting motor or cognitive function, in the opinion of the investigator.
•3. History of intolerance to any of the components of the study drug.
•4. History of stroke.
•5. Active oncological process.
•6. The need for surgeries on the vessels of the neck or brain, including endovascular interventions, during the study.
•7. Signs of significant uncontrolled concomitant disease that, in the opinion of the Investigator, could prevent the patient from participating in the study, including:
•* Respiratory system disorders;
•* Cardiovascular system disorders;
•* Severe renal impairment (glomerular filtration rate \<30ml/min);
+15 more criteria

Locations (7)

State autonomous healthcare institution "Transregional Clinical Diagnostic Center"

Kazan', Russia

Federal State Budgetary Institution "Federal center for brain and neurotechnologies" of the Federal Medical and Biological Agency (FSBI "FCBN" of Russia's FMBA)

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

State public healthcare institution Leningrad regional psychoneurologic dispensary

Roshchino, Russia

"Medical Center Nova Vita"

Rostov-on-Don, Russia

Saint Petersburg State budgetary healthcare institution "City Hospital № 40 of Kurortniy district"

Saint Petersburg, Russia

"Centre of evidence-based medicine" LLC

Yaroslavl, Russia

Key Dates

Start Date

December 27, 2023

Primary Completion Date

January 13, 2025

Completion Date

January 31, 2025

Last Updated

March 28, 2025

Enrollment

133

ACTUAL participants

Conditions

Alzheimer DiseaseDementia of Alzheimer Type

Interventions

DMB-I (Dimebon)

DRUG

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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DMB-I in the Treatment of Alzheimer Type Dementia

Inclusion Criteria

Exclusion Criteria

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