Alzheimer DiseasePhase 2NCT06292351
DMB-I in the Treatment of Alzheimer Type Dementia
A Phase 2 study testing DMB-I (Dimebon) in people with Alzheimer Disease and Dementia of Alzheimer Type, run by Bigespas LTD at 7 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Alzheimer Disease, Dementia of Alzheimer Type
- What is being tested?
- DMB-I (Dimebon)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 133 participants
- Where
- 7 sitesRussia
- Study dates
- 27 Dec 2023to 31 Jan 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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.
- 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 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.
- Patients who are able to undergo the tests provided for in the protocol.
Who cannot join
- 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.
- 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.
- 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). Situational use of psychotropic drugs (e.g., for the treatment of insomnia, or to relieve agitation and anxiety) is permitted
- Moderate to severe depression (Hamilton scale score of 14 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.
- Episodes of other serious or unstable neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal or urological disorders.
- Myocardial infarction within 12 months prior to screening.
- Known systemic infection (viral hepatitis, HIV, tuberculosis, syphilis).
- Life expectancy less than 26 weeks after randomization.
- Men of reproductive potential who are unwilling to use adequate contraceptive methods.
- Participation in another clinical trial within the last 6 months.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Russia7 sites
State autonomous healthcare institution "Transregional Clinical Diagnostic Center"
Kazan', 420101
Federal State Budgetary Institution "Federal center for brain and neurotechnologies" of the Federal Medical and Biological Agency (FSBI "FCBN" of Russia's FMBA)
Moscow, 117997
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
State public healthcare institution Leningrad regional psychoneurologic dispensary
Roshchino, 188820
"Medical Center Nova Vita"
Rostov-on-Don, 344082
Saint Petersburg State budgetary healthcare institution "City Hospital № 40 of Kurortniy district"
Saint Petersburg, 197706
"Centre of evidence-based medicine" LLC
Yaroslavl, 150000
About this study
Official title: 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
The purpose of this study is to assess the efficacy and safety of DMB-I for the treatment of patients with Alzheimer type dementia.
Read the 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:
- DMB-I (Dimebon) 1 tab + Placebo 1 tab 3 times a day.
- DMB-I (Dimebon) 2 tab 3 times a day.
- 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.
- Conditions
- Alzheimer Disease, Dementia of Alzheimer Type
- Being tested
- DMB-I (Dimebon), 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 (Dimebon)Drug
20 mg 3 times a day, or 10 mg + 10 mg 3 times a day (for DMB-I + Placebo arm)
PlaceboOther
20 mg 3 times a day, or 10 mg + 10 mg 3 times a day (for DMB-I + Placebo arm)
| Study group | Role | What they receive |
|---|---|---|
| DMB-I (Dimebon) + Placebo | Experimental | Not described Receives: Drug: DMB-I (Dimebon); Other: Placebo |
| DMB-I (Dimebon) | Experimental | Not described Receives: Drug: DMB-I (Dimebon) |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in Alzheimer's Disease Assessment Scale score after 26 weeks of therapy (Visit 6) compared to baseline (Visit 0) in patients receiving the study drug or placebo
The scale's minimum score - 0, maximum score - 82, where the higher score means the worse outcome
Measured: Baseline (Visit 0) and 26 weeks (Visit 6)
Secondary outcomes (5)
Mean change in cognitive impairment score on the Alzheimer's Disease Assessment Scale after 12 weeks of therapy compared to baseline
The scale's minimum score - 0, maximum score - 82, where the higher score means the worse outcome
Measured: Baseline (Visit 1) and 12 weeks of therapy (Visit 4)
Mean change in Mini-Mental State Examination score after 12 weeks of therapy (Visit 4) and after 26 weeks of therapy (Visit 6) compared to baseline (Visit 0)
The min/max score values are 0/30 respectively, where the higher score means the better outcome
Measured: Baseline (Visit 0), 12 weeks of therapy (Visit 4) and 26 weeks of therapy (Visit 6)
Change in the quality of life of patients according to the Quality of Life - Alzheimer's Disease questionnaire after 12 weeks of therapy (Visit 4) and after 26 weeks of therapy (Visit 6) compared to baseline (Visit 1)
The scale has 13 items, that may be evaluated on 13-52 points, where the higher score means the better outcome
Measured: Baseline (Visit 1), 12 weeks of therapy (Visit 4) and 26 weeks of therapy (Visit 6)
Change in the general clinical impression in accordance with the Clinical Global Impressions Scale after 12 weeks of therapy (Visit 4) and after 26 weeks of therapy (Visit 6) compared to baseline (Visit 1)
The scale consists of 3 blocks, which may be evaluated on 0 to 7 points for each of the first two blocks, and on 1 to 16 points for the third block. The higher score means the worse outcome.
Measured: Baseline (Visit 1), 12 weeks of therapy (Visit 4) and 26 weeks of therapy (Visit 6)
Dynamics on the Lawton's Instrumental activities of daily living scale after 12 weeks of therapy (Visit 4) and after 26 weeks of therapy (Visit 6) compared to baseline (Visit 1)
The min/max score values are 0/8 respectively, where the higher score means the worse outcome
Measured: Baseline (Visit 1), 12 weeks of therapy (Visit 4) and 26 weeks of therapy (Visit 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start27 Dec 2023
- Primary completion13 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bigespas LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06292351
- Sponsor's protocol ID
- DMBN_ALZH-2022-II
- Status last verified
- Mar 2025
- First submitted
- 27 Feb 2024
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gorin BI, Pozdnyakov SO, Potapova KA, Tukhovskaya EA, Gorchakov DS. Efficacy and safety of DMB-I (latrepirdine) therapy in mild to moderate dementia in Alzheimer's disease: results of a multicenter, double-blind, randomized, placebo-controlled, clinical trial in three parallel groups. Sci Rep. 2026 May 15;16(1):14027. doi: 10.1038/s41598-026-49538-4.
PubMed 42141012
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06292351
- Acronym / sponsor ID
- DMBN_ALZH-2022-II
- Conditions
- Alzheimer Disease, Dementia of Alzheimer Type
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Bigespas LTDIndustry (pharma, biotech, devices)
- Study start
- 27 Dec 2023 (actual)
- Primary completion
- 13 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 5 Mar 2024 (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 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:
- DMB-I (Dimebon) 1 tab + Placebo 1 tab 3 times a day.
- DMB-I (Dimebon) 2 tab 3 times a day.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DMB-I (Dimebon) + Placebo | Experimental | Drug: DMB-I (Dimebon), Other: Placebo |
| DMB-I (Dimebon) | Experimental | Drug: DMB-I (Dimebon) |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- 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.
Key exclusion criteria (25 listed)
- 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.
- 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 (Dimebon)20 mg 3 times a day, or 10 mg + 10 mg 3 times a day (for DMB-I + Placebo arm) | Drug | DMB-I (Dimebon), DMB-I (Dimebon) + Placebo |
| Placebo20 mg 3 times a day, or 10 mg + 10 mg 3 times a day (for DMB-I + Placebo arm) | Other | DMB-I (Dimebon) + Placebo, Placebo |
Primary outcome
Mean change in Alzheimer's Disease Assessment Scale score after 26 weeks of therapy (Visit 6) compared to baseline (Visit 0) in patients receiving the study drug or placebo
Time frame: Baseline (Visit 0) and 26 weeks (Visit 6)
The scale's minimum score - 0, maximum score - 82, where the higher score means the worse outcome
5 secondary outcomes
Mean change in cognitive impairment score on the Alzheimer's Disease Assessment Scale after 12 weeks of therapy compared to baseline
Time frame: Baseline (Visit 1) and 12 weeks of therapy (Visit 4)
Mean change in Mini-Mental State Examination score after 12 weeks of therapy (Visit 4) and after 26 weeks of therapy (Visit 6) compared to baseline (Visit 0)
Time frame: Baseline (Visit 0), 12 weeks of therapy (Visit 4) and 26 weeks of therapy (Visit 6)
Change in the quality of life of patients according to the Quality of Life - Alzheimer's Disease questionnaire after 12 weeks of therapy (Visit 4) and after 26 weeks of therapy (Visit 6) compared to baseline (Visit 1)
Time frame: Baseline (Visit 1), 12 weeks of therapy (Visit 4) and 26 weeks of therapy (Visit 6)
Change in the general clinical impression in accordance with the Clinical Global Impressions Scale after 12 weeks of therapy (Visit 4) and after 26 weeks of therapy (Visit 6) compared to baseline (Visit 1)
Time frame: Baseline (Visit 1), 12 weeks of therapy (Visit 4) and 26 weeks of therapy (Visit 6)
Dynamics on the Lawton's Instrumental activities of daily living scale after 12 weeks of therapy (Visit 4) and after 26 weeks of therapy (Visit 6) compared to baseline (Visit 1)
Time frame: Baseline (Visit 1), 12 weeks of therapy (Visit 4) and 26 weeks of therapy (Visit 6)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Derived from this study: PubMed 42141012Gorin BI, Pozdnyakov SO, Potapova KA, Tukhovskaya EA, Gorchakov DS. Efficacy and safety of DMB-I (latrepirdine) therapy in mild to moderate dementia in Alzheimer's disease: results of a multicenter, double-blind, randomized, placebo-controlled, clinical trial in three parallel groups. Sci Rep. 2026 May 15;16(1):14027. doi: 10.1038/s41598-026-49538-4.
- Differences in bioavailability and cognitive-enhancing activity exerted by different crystal polymorphs of latrepirdine (Dimebon®)Link provided by the sponsor.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DMB-I (Dimebon) in people with Alzheimer Disease and Dementia of Alzheimer Type, run by Bigespas LTD at 7 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 7 inclusion and 25 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: finished, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in Alzheimer's Disease Assessment Scale score after 26 weeks of therapy (Visit 6) compared to baseline (Visit 0) in patients receiving the study drug or placebo (time frame: Baseline (Visit 0) and 26 weeks (Visit 6)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06292351, which also lists 1 linked publication.
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 28 Mar 2025.