Local Study of Akatinol Memantine in VaD in Russia

Inclusion criteria

• Written informed consent obtained from the patient or his/her legal representative if the patient is declared incapable by a court decision.
• Understanding of study procedures and willingness to abide to all procedures during the course of the study by the patient or his/her legal representative.
• Male and female patients from 50 to 85 years of age (inclusive) suffering from moderate and moderately severe vascular dementia.
• Mini-Mental State Examination (MMSE) Test total scores of 10 to 20.
• Hachinski's Ischemic Score (HIS) of 7 or higher point.
• Availability in the anamnesis of instrumental confirmation of the diagnosis (data methods of neurovisualization - CT or MRT).
• For females: menopause or inability to conceive due to other reasons (hysterectomy, etc.).
• Availability of a relative or legal representative who lives with the patient, monitors him/her and cares for the patient.

Exclusion criteria

• Alzheimer's disease or secondary types of dementia.
• Epilepsy, seizures, schizophrenia, other psychoses, bipolar disorder, alcoholism, drug abuse (including the history thereof).
• Other clinically significant neurological or psychiatric disorders.
• Severe depression (Hamilton score, HAM-D > 18 points).
• Severe, unstable or decompensated physical disease (including clinically significant laboratory abnormalities) potentially affecting the trial findings.
• Contraindications to oral drug intake during the time period determined by the study protocol.
• Known hypersensitivity to the investigational product or any of its ingredients.
• Administration of nootropic, anti-dementia and typical antipsychotic drugs, tricyclic antidepressants, long-acting benzodiazepines, NMDA receptor antagonists (amantadine, ketamine, dextromethorphan) for 1 month before the enrollment and during the study.
• For females: pregnancy and breastfeeding.
• Evidence or suspicion that the patient might not comply with the study directive.
• Any reason or contraindication which in the investigator's opinion precludes participation in the study.
• Patient is direct relative of an employee of the study site or Merz Pharma LLC.
• Previous participation in this clinical study.
• Participation in another clinical trial within the last 12 weeks prior to screening or ongoing participation in a study.