DMB-I in the Treatment of Alzheimer Type Dementia

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 theNINCDS-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 AcuteCerebrovascular Accidents (focal infarctions) in brain areas that are critical forcognitive functions and behavior are the mandatory neuroimaging signs of vasculardementia.

6. The presence of a caregiver who is in contact with the patient a significant part ofthe time, agrees to accompany the patient to all visits, monitor the intake of thestudy 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 tomedical history, medical documentation and the results of additional examinationmethods.

2. History of other neurodegenerative diseases of the brain, Parkinson's disease,multiple sclerosis, demyelinating diseases of the nervous system, hereditarydegenerative diseases of the central nervous system, abnormalities of the nervoussystem, uncontrolled epilepsy, hallucinations, other neurological disordersseriously 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 endovascularinterventions, during the study.

7. Signs of significant uncontrolled concomitant disease that, in the opinion of theInvestigator, 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 currenttreatment with systemic drugs.

9. Use of drugs that negatively affect cognitive function (tricyclic antidepressants,benzodiazepines, antipsychotics, hypnotics, etc.), as well as drugs of prohibitedtherapy (including Cerebrolysin, preparations of ginkgo biloba extract, any otherdrugs with nootropic, antioxidant, metabolic effects, as well as drugs used to treatdementia). Situational use of psychotropic drugs (e.g., for the treatment ofinsomnia, 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 opinionof 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 contraceptivemethods.

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