Local Study of Akatinol Memantine in VaD in Russia

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merz Pharmaceuticals GmbH
• Collaborator: LLC Merz Pharma, Russia
• Treatments: Memantine

Criteria

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.