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

NCT07251023 | Recruiting Phase 3

• 1 other identifier: DMBN_ALZH-2025-III
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 12

Brief 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

Outcome Measures

Primary Outcomes (1)

• Assessment of the change in ADAS-Cog Scale overall score at Week 26 compared to baseline (Week 0) in patients receiving DMB-I (Group 1) Vs. patients receiving placebo (Group 2)

  ADAS-Cog Scale consists of 12 questions. The scale's minimum score - 0, maximum score - 88, where the higher score means the worse outcome

  Baseline (Week 0) Vs. Week 26

Secondary Outcomes (2)

• Assessment of the change in ADAS-Cog Scale overall score at Week 26 compared to baseline (Week 0) in patients receiving DMB-I (Group 3) Vs. patients receiving placebo (Group 2)

  Baseline (Week 0) Vs. Week 26

• Change in ADAS-Cog Scale overall score at Week 4, Week 12, Week 26, Week 30, Week 38, and Week 52 compared to baseline (Week 0) across all treatment groups

  Baseline (Week 0) Vs. Week 4, Week 12, Week 26, Week 30, Week 38, Week 52

Other Outcomes (5)

• Change in ADAS-Cog component scores (Item 1: Word Learning, Item 4: Delayed Word Recall, Item 6: Ideational Praxis, Item 7: Orientation) at Week 4, Week 12, Week 26, Week 30, Week 38, and Week 52 compared to baseline (Week 0) across all treatment groups

  Baseline (Week 0) Vs. Week 4, Week 12, Week 26, Week 30, Week 38, Week 52

• Change in the Neuropsychiatric Inventory (NPI) behavioral symptom frequency and severity at Week 4, Week 12, Week 26, Week 30, Week 38, and Week 52 compared to baseline (Week 0) across all treatment groups

  Baseline (Week 0) Vs. Week 4, Week 12, Week 26, Week 30, Week 38, Week 52

• Change in Instrumental Activities of Daily Living (IADL) overall score at Week 4, Week 12, Week 26, Week 30, Week 38, and Week 52 compared to baseline (Week 0) across all treatment groups

  Baseline (Week 0) Vs. Week 4, Week 12, Week 26, Week 30, Week 38, Week 52

Study Arms (3)

DMB-I (INN: Latrepirdine)

EXPERIMENTAL

DMB-I (INN: Latrepirdine), 10 mg, 2 tablets 3 times daily (Group 3: DMB-I)

Drug: DMB-I (INN: Latrepirdine)

Placebo + Memantine Hydrochloride

PLACEBO COMPARATOR

Placebo, 2 tablets 3 times daily + Akatinol Memantine®, 20 mg once daily (Group 2: Placebo + Memantine).

Drug: Memantine Hydrochloride 20 MG; Drug: Placebo

DMB-I (INN: Latrepirdine) + Memantine Hydrochloride

ACTIVE COMPARATOR

DMB-I (INN: Latrepirdine), 10 mg, 2 tablets 3 times daily + Akatinol Memantine®, 20 mg once daily (Group 1: DMB-I + Memantine)

Drug: DMB-I (INN: Latrepirdine); Drug: Memantine Hydrochloride 20 MG

Interventions

DMB-I (INN: Latrepirdine) DRUG

Active agent: Dimethylmethylpyridinylethyltetrahydrocarboline. Investigational drug in the study

Also known as: Latrepirdine, Dimebon®

DMB-I (INN: Latrepirdine); DMB-I (INN: Latrepirdine) + Memantine Hydrochloride

Memantine Hydrochloride 20 MG DRUG

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

Also known as: Akatinol Memantine®

DMB-I (INN: Latrepirdine) + Memantine Hydrochloride; Placebo + Memantine Hydrochloride

Placebo DRUG

Placebo comparator (dummy) in the study.

Placebo + Memantine Hydrochloride

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent to participate in the study.
• Patients of any gender aged 60 to 90 years inclusive.
• 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.
• The MMSE score is in the range of 10-23 inclusive.
• The ADAS-Cog score is in the range of 20-54 inclusive.
• 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.
• The Modified Hachinski Ischemic Scale (HIS) score is \< 7.
• 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.
• An ability to comply with all Protocol requirements.
• Informed consent to participate in the study.
• Patients of any gender aged 60 to 90 years inclusive.
• Patients diagnosed with mild to moderate Alzheimer type dementia according to the NINCDS-ADRDA criteria, who are not receiving dementia-contolling medications (memantine, donepezil, rivastigmine, or galantamine) at screening or for the last two (or more) months prior to screening; however, taking such medications for more than two months prior to screening does not limit a patient's participation in the study.
• The MMSE score is in the range of 10-23 inclusive.
• The ADAS-Cog score is in the range of 20-54 inclusive.
• 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.

You may not qualify if:

• Patients diagnosed with other diseases that cause dementia (severe hypothyroidism, anemia, brain tumor, neuroinfections, etc.) at screening.
• 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.
• History of intolerance to any of the components of the study drug.
• History of stroke.
• Active oncological process.
• The need for surgeries on the vessels of the neck or brain, including endovascular interventions, during the study.
• 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);
• Severe liver dysfunction (ALT, AST \> 2 times the upper limit of normal);
• Endocrine system disorders;
• Gastrointestinal disorders.
• Systemic autoimmune diseases or vascular collagenoses requiring previous or current treatment with systemic drugs.
• Myocardial infarction within 12 months prior to screening.

Sponsors & Collaborators

• Bigespas LTD: lead

Study Sites (12)

State autonomous healthcare institution "Transregional Clinical Diagnostic Center"

Kazan', 420101, Russia

RECRUITING

Moscow State budgetary healthcare institution "City Clinical Hospital named after V.M. Buyanov of the Moscow Healthcare Department"

Moscow, 115516, Russia

RECRUITING

Federal State Budgetary Institution "Federal Center for Brain and Neurotechnology" of the Federal Medical and Biological Agency

Moscow, 117513, Russia

RECRUITING

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, 119991, Russia

RECRUITING

Nizhny Novgorod region State budgetary healthcare institution " Nizhny Novgorod Clinical Psychiatric Hospital No. 1"

Nizhny Novgorod, 603155, Russia

RECRUITING

State budgetary healthcare institution "Leningrad Regional Mental Health Center"

Roshchino, 188820, Russia

RECRUITING

"Medical Center Nova Vita" LLC

Rostov-on-Don, 344082, Russia

RECRUITING

Saint Petersburg State budgetary healthcare institution "Psychiatric Hospital No. 1 named after P.P. Kashchenko"

Saint Petersburg, 188357, Russia

RECRUITING

"Medical services" LLC

Saint Petersburg, 194356, Russia

RECRUITING

Saint Petersburg State budgetary healthcare institution "Psychoneurologic dispensary № 5"

Saint Petersburg, 195176, Russia

RECRUITING

"Sphera Med" LLC

Saint Petersburg, 197342, Russia

RECRUITING

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

Saint Petersburg, 197706, Russia

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Interventions

latrepirdine; Memantine

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Anna Rashina

CONTACT

+74952761143; aar@ipharma.ru

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: placebo-controlled and active comparator-controlled two-stage study

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 26, 2025
• Study Start: November 20, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

RU (12)