Local Study of Akatinol Memantine in VaD in Russia (MIND)

Merz Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Vascular Dementia

Treatments

Drug: Akatinol Memantine 10 mg

Drug: Akatinol Memantine 20 mg

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT03986424

M900011005

Details and patient eligibility

About

The study evaluates the clinical efficacy and safety of Akatinol Memantine 20 mg (single-doses) vs. Akatinol Memantine 10 mg (double-doses) in patients suffering from moderate and moderately severe vascular dementia.

Enrollment

130 patients

Sex

All

Ages

50 to 85 years old

Volunteers

No Healthy Volunteers

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.