Prospekta in the Treatment of Cognitive, Behavioral and Psychiatric Disorders in Patients With Vascular Dementia.

Inclusion Criteria

• Subjects aged 60-85 years old inclusively.
• Subjects with verified diagnosis of vascular dementia.
• Presence of all the vascular dementia criteria according to NINDS-AIREN:

A. Presence of dementia, which is defined as a decline in cognitive function relative to the previous level of functioning, manifested by impairments in memory and two or more cognitive domains (orientation, attention, language, visuospatial functions, executive functions, motor control and praxis), preferably established during a clinical trial and confirmed by neuropsychological testing.

The cognitive impairment must be so severe that it affects daily activity, reducing it independently of the physical consequences of the stroke.

B. The presence of cerebrovascular disease, confirmed by signs of focal damage on neurological examination, such as hemiparesis, lower facial weakness, Babinski sign, sensory deficit, hemianopsia or dysarthria associated with stroke (either a history of stroke or absence of such anamnestic information), and neuroimaging (CT or MRI) signs of cerebrovascular disease, including multiple infarcts in the territory of large vessels, or a single infarction in a strategically important area (angular gyrus, thalamus, basal ganglia, or the territory of the anterior or posterior cerebral arteries), as well as multiple lacunae in the region of the basal ganglia or white matter, or significant damage to the periventricular white matter, or a combination of the above lesions.

C. There is an association between dementia and cerebrovascular disease as follows:

• onset of dementia within 3 months of stroke;
• sharp deterioration of cognitive functions; or fluctuating, stepwise progression of cognitive impairment.
• Availability of permanent caregiver throughout the study (nurse or relatives).
• Total Mini-Mental State Examination (MMSE) score - 10-24.
• Total MoCA score <26.
• Total NPI-C aggression and agitation domain score ≥14.
• Аbsence of depression (total Cornell Scale for Depression in Dementia (CSDD) score ≤10).
• Brain MRI confirming the diagnosis of vascular dementia within 1 year prior to enrollment (or brain MRI performed at enrollment visit).
• Patients giving their consent to use reliable contraception throughout the study (for males).
• Availability of signed patient information sheet and informed consent form for participation in the clinical trial.

Exclusion Criteria

• Signs of intracerebral hemorrhage, brain tumours causing dementia.
• Alzheimer's disease, Parkinson disease, Lewy body dementia, multiple system atrophy, Jacob-Creutzfeld disease, Pick syndrome, corticobasal degeneration.
• Injuries of head (S00-S09) associated with impaired consciousness, cerebral contusion or open craniocerebral traumas.
• Toxicity-related dementia (including drug-induced), multiorgan failure or metabolic and toxic disorders (chronic hypothyroidism, decompensated diabetes mellitus, avitaminoses, etc.).
• Other psychiatric diseases besides dementia: mental disorders and behavioral disorders due to use of psychoactive substances (F10-19) schizophrenia, schizotypal and delusional disorders (F20-29).
• Mental retardation (F70-79).
• Inflammatory lesions of the brain with persistent neurological deficit.
• Malignant neoplasms.
• Previously diagnosed cardiovascular diseases with functional class IV (according to New York Heart Association, 1964).
• Unstable angina pectoris, myocardial infarction or ischemic stroke within the last 6 months.
• Female patients with childbearing potency.
• Allergy/intolerance of any of the study drugs components including secondary to lactase deficiency.
• Any conditions which, according to the investigator opinion, may interfere with the patient's participation in the study.
• History of treatment noncompliance, mental diseases, alcoholism or drug abuse which will prevent from following the study procedures, according to investigator's opinion.
• Particip