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CompletedPhase 2

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

Lead sponsor

Bigespas LTD

Asset

Dimebon

Listed sites

7

Recruiting sites

-

Enrollment

133

actual

Study population

Alzheimer’s disease

Key I/E criteria

mild-to-moderate ADMMSE 10-23

Primary endpoint

Alzheimer's Disease Assessment Scale score after 26 weeks of therapy (Visit 6)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDDMBN_ALZH-2022-II
NCT IDNCT06292351

Timeline

Milestones

Study start2023-12-27actual
Study first posted2024-03-05actual
Primary completion2025-01-13actual
Study completion2025-01-31actual
Last update posted2025-03-28actual

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age60 Years
Maximum age90 Years
SexAll
Healthy volunteersNot accepted

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);
-Severe liver dysfunction (ALT, AST > 2 times the upper limit of normal);
-Endocrine system disorders;
-Gastrointestinal disorders.

8. Systemic autoimmune diseases or vascular collagenoses requiring previous or current treatment with systemic drugs.

9. 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

10. Moderate to severe depression (Hamilton scale score of 14 or more).

11. Smoking.

12. Episodes of alcohol or drug abuse within the last 6 months.

13. Inability to comply with study procedures even with the assistance, in the opinion of the investigator.

14. Episodes of other serious or unstable neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal or urological disorders.

15. Myocardial infarction within 12 months prior to screening.

16. Known systemic infection (viral hepatitis, HIV, tuberculosis, syphilis).

17. Life expectancy less than 26 weeks after randomization.

18. Men of reproductive potential who are unwilling to use adequate contraceptive methods.

19. Participation in another clinical trial within the last 6 months.

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
3
Global cognition
1
Function / daily living
1
Caregiver / quality of life
1

Global cognition

1 endpoint
Secondary/protocol endpoint

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)

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Function / daily living

1 endpoint
Secondary/protocol endpoint

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)

descriptive

Caregiver / quality of life

1 endpoint
Secondary/protocol endpoint

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 from baseline, improvement

Other (unclassified)

3 endpoints
Primary/protocol endpoint/low confidence

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)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

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)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

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)

change from baseline, improvement

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.