Alzheimer Type DementiaPhase 3NCT07251023
Efficacy and Safety of DMB-I (INN: Latrepirdine) in Patients With Alzheimer Type Dementia
A Phase 3 study testing DMB-I (INN: Latrepirdine) and Memantine Hydrochloride 20 MG in people with Alzheimer Type Dementia, run by Bigespas LTD at 12 sites in Russia.
Trial 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). Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Alzheimer Type Dementia
- What is being tested?
- DMB-I (INN: Latrepirdine) and Memantine Hydrochloride 20 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 12 sitesRussia
- Study dates
- 20 Nov 2025to May 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- 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.
Who cannot join
- 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.
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- 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.
- Known systemic infection (viral hepatitis, HIV, tuberculosis, syphilis).
- Life expectancy less than a year after randomization.
- Use of drugs that negatively affect cognitive function (tricyclic antidepressants, benzodiazepines, antipsychotics, hypnotics, etc.), as well as drugs of prohibited therapy (including Cerebrolysin, preparations of ginkgo biloba extract, any other drugs with nootropic, antioxidant, metabolic effects, as well as drugs used to treat dementia) within 1 month prior to screening.
- Moderate to severe depression (Hamilton scale score of 18 or more).
- Smoking.
- Episodes of alcohol or drug abuse within the last 6 months.
- Inability to comply with study procedures even with the assistance, in the opinion of the investigator.
- Participation in another clinical trial within the last 6 months.
- Episodes of other serious or unstable psychiatric conditions that make the patient unsuitable for participation in a clinical study, alter the validity of obtaining an informed consent, or may affect the patient's ability to participate in the trial.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
Russia12 sites, 12 recruiting
- Recruiting
State autonomous healthcare institution "Transregional Clinical Diagnostic Center"
Kazan', 420101
- Recruiting
Moscow State budgetary healthcare institution "City Clinical Hospital named after V.M. Buyanov of the Moscow Healthcare Department"
Moscow, 115516
- Recruiting
Federal State Budgetary Institution "Federal Center for Brain and Neurotechnology" of the Federal Medical and Biological Agency
Moscow, 117513
- 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
- Recruiting
Nizhny Novgorod region State budgetary healthcare institution " Nizhny Novgorod Clinical Psychiatric Hospital No. 1"
Nizhny Novgorod, 603155
- Recruiting
State budgetary healthcare institution "Leningrad Regional Mental Health Center"
Roshchino, 188820
- Recruiting
"Medical Center Nova Vita" LLC
Rostov-on-Don, 344082
- Recruiting
Saint Petersburg State budgetary healthcare institution "Psychiatric Hospital No. 1 named after P.P. Kashchenko"
Saint Petersburg, 188357
- Recruiting
"Medical services" LLC
Saint Petersburg, 194356
- Recruiting
Saint Petersburg State budgetary healthcare institution "Psychoneurologic dispensary № 5"
Saint Petersburg, 195176
- Recruiting
"Sphera Med" LLC
Saint Petersburg, 197342
- Recruiting
Saint Petersburg State budgetary healthcare institution "City Hospital No. 40 of Kurortniy district"
Saint Petersburg, 197706
About this study
Official title: Multicenter Randomized Double-blind Placebo-controlled Active Comparator-controlled Study to Assess the Efficacy and Safety of DMB-I (Dimebon®, INN: Latrepirdine) in Patients With Dementia Associated With Alzheimer's Disease
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:
Read more
- 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
Read the detailed description
This is a multicenter randomized double-blind placebo-controlled two-stage study that is to assess efficacy and safety of DMB-I (INN: Latrepirdine) in patients with Alzheimer type dementia.
The study is planned to be conducted in approximately 15 clinical sites of the Russian Federation.
At Stage 1 (comparative stage, 26 weeks), the study will examine three treatment groups. Patients in Group 1 and Group 2 will receive Akatinol Memantine® in addition to the study therapy (DMB-I or Placebo). Patients in Group 3 will receive DMB-I alone. The study is double-blind for DMB-I and Placebo; Akatinol Memantine® will not be blinded.
Patients meeting all the eligibility criteria will be randomized into one of three treatment groups:
- DMB-I, 10 mg, 2 tablets 3 times daily + Akatinol Memantine®, 20 mg once daily - 175 patients (Group 1: DMB-I + Memantine).
- Placebo, 2 tablets 3 times daily + Akatinol Memantine®, 20 mg once daily - 175 patients (Group 2: Placebo + Memantine).
- DMB-I, 10 mg, 2 tablets 3 times daily - 100 patients (Group 3: DMB-I). Following completion of Stage 1, patients will continue participating in the open-label stage of the study (Stage 2) for additional 26 weeks to evaluate the long-term efficacy and safety of DMB-I. During this stage, patients in Group 1 (DMB-I + Memantine) will continue their study therapy unchanged. Patients in Group 2 (Placebo + Memantine) will discontinue Placebo and begin therapy with DMB-I (while continuing to take Akatinol Memantine®). Patients in Group 3 (DMB-I monotherapy) will also continue their therapy unchanged.
The total study duration for each patient is approximately 56 weeks broken down as follows:
Screening period: up to 2 weeks, Treatment period (Stage 1): 26 weeks, Treatment period (Stage 2): 26 weeks, Follow-up period: 2 weeks.
- Conditions
- Alzheimer Type Dementia
- Being tested
- DMB-I (INN: Latrepirdine), Memantine Hydrochloride 20 MG, Placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DMB-I (INN: Latrepirdine)Drug
Also called Latrepirdine, Dimebon®
Active agent: Dimethylmethylpyridinylethyltetrahydrocarboline. Investigational drug in the study
Memantine Hydrochloride 20 MGDrug
Also called Akatinol Memantine®
Memantine is used to treat moderate to severe Alzheimer's disease. Active comparator drug in the study
PlaceboDrug
Placebo comparator (dummy) in the study.
| Study group | Role | What they receive |
|---|---|---|
| DMB-I (INN: Latrepirdine) | Experimental | DMB-I (INN: Latrepirdine), 10 mg, 2 tablets 3 times daily (Group 3: DMB-I) Receives: 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). Receives: 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) Receives: Drug: DMB-I (INN: Latrepirdine); Drug: Memantine Hydrochloride 20 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
ADAS-Cog Scale consists of 12 questions. The scale's minimum score - 0, maximum score - 88, where the higher score means the worse outcome
Measured: 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
ADAS-Cog Scale consists of 12 questions. The scale's minimum score - 0, maximum score - 88, where the higher score means the worse outcome
Measured: Baseline (Week 0) Vs. Week 4, Week 12, Week 26, Week 30, Week 38, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start20 Nov 2025
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Type DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- placebo-controlled and active comparator-controlled two-stage study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bigespas LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07251023
- Sponsor's protocol ID
- DMBN_ALZH-2025-III
- Status last verified
- Dec 2025
- First submitted
- 14 Nov 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Double-blind Placebo-controlled Active Comparator-controlled Study to Assess the Efficacy and Safety of DMB-I (Dimebon®, INN: Latrepirdine) in Patients With Dementia Associated With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT07251023
- Acronym / sponsor ID
- DMBN_ALZH-2025-III
- Conditions
- Alzheimer Type Dementia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Bigespas LTDIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This is a multicenter randomized double-blind placebo-controlled two-stage study that is to assess efficacy and safety of DMB-I (INN: Latrepirdine) in patients with Alzheimer type dementia.
The study is planned to be conducted in approximately 15 clinical sites of the Russian Federation.
At Stage 1 (comparative stage, 26 weeks), the study will examine three treatment groups. Patients in Group 1 and Group 2 will receive Akatinol Memantine® in addition to the study therapy (DMB-I or Placebo). Patients in Group 3 will receive DMB-I alone. The study is double-blind for DMB-I and Placebo; Akatinol Memantine® will not be blinded.
Patients meeting all the eligibility criteria will be randomized into one of three treatment groups:
- DMB-I, 10 mg, 2 tablets 3 times daily + Akatinol Memantine®, 20 mg once daily - 175 patients (Group 1: DMB-I + Memantine).
- Placebo, 2 tablets 3 times daily + Akatinol Memantine®, 20 mg once daily - 175 patients (Group 2: Placebo + Memantine).
- DMB-I, 10 mg, 2 tablets 3 times daily - 100 patients (Group 3: DMB-I). Following completion of Stage 1, patients will continue participating in the open-label stage of the study (Stage 2) for additional 26 weeks to evaluate the long-term efficacy and safety of DMB-I. During this stage, patients in Group 1 (DMB-I + Memantine) will continue their study therapy unchanged. Patients in Group 2 (Placebo + Memantine) will discontinue Placebo and begin therapy with DMB-I (while continuing to take Akatinol Memantine®). Patients in Group 3 (DMB-I monotherapy) will also continue their therapy unchanged.
The total study duration for each patient is approximately 56 weeks broken down as follows:
Screening period: up to 2 weeks, Treatment period (Stage 1): 26 weeks, Treatment period (Stage 2): 26 weeks, Follow-up period: 2 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- placebo-controlled and active comparator-controlled two-stage study
| Arm | Type | Receives |
|---|---|---|
| DMB-I (INN: Latrepirdine) | Experimental | Drug: DMB-I (INN: Latrepirdine)DMB-I (INN: Latrepirdine), 10 mg, 2 tablets 3 times daily (Group 3: DMB-I) |
| Placebo + Memantine Hydrochloride | Placebo comparator | Drug: Memantine Hydrochloride 20 MG, Drug: PlaceboPlacebo, 2 tablets 3 times daily + Akatinol Memantine®, 20 mg once daily (Group 2: Placebo + Memantine). |
| DMB-I (INN: Latrepirdine) + Memantine Hydrochloride | Active comparator | Drug: DMB-I (INN: Latrepirdine), Drug: Memantine Hydrochloride 20 MGDMB-I (INN: Latrepirdine), 10 mg, 2 tablets 3 times daily + Akatinol Memantine®, 20 mg once daily (Group 1: DMB-I + Memantine) |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DMB-I (INN: Latrepirdine)Also: Latrepirdine, Dimebon®Active agent: Dimethylmethylpyridinylethyltetrahydrocarboline. Investigational drug in the study | Drug | DMB-I (INN: Latrepirdine), DMB-I (INN: Latrepirdine) + Memantine Hydrochloride |
| Memantine Hydrochloride 20 MGAlso: Akatinol Memantine®Memantine is used to treat moderate to severe Alzheimer's disease. Active comparator drug in the study | Drug | DMB-I (INN: Latrepirdine) + Memantine Hydrochloride, Placebo + Memantine Hydrochloride |
| PlaceboPlacebo comparator (dummy) in the study. | Drug | Placebo + Memantine Hydrochloride |
Primary outcome
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)
Time frame: Baseline (Week 0) Vs. Week 26
ADAS-Cog Scale consists of 12 questions. The scale's minimum score - 0, maximum score - 88, where the higher score means the worse outcome
2 secondary outcomes
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)
Time frame: 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
Time frame: Baseline (Week 0) Vs. Week 4, Week 12, Week 26, Week 30, Week 38, Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DMB-I (INN: Latrepirdine) and Memantine Hydrochloride 20 MG in people with Alzheimer Type Dementia, run by Bigespas LTD at 12 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Rashina (+74952761143, aar@ipharma.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: Baseline (Week 0) Vs. Week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.