Local Study of Akatinol Memantine in VaD in Russia

NCT ID: NCT03986424

Last Updated: 2022-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-23
• Study Completion Date: 2022-06-01

Brief 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.

Conditions

Vascular Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Akatinol Memantine 20 mg

Akatinol Memantine 20 mg once daily

Group Type: EXPERIMENTAL

Akatinol Memantine 20 mg

Intervention Type: DRUG

Akatinol Memantine 20 mg to be taken orally, once daily, in the same time of the day

Akatinol Memantine 10 mg

Akatinol Memantine 10 mg twice daily

Group Type: ACTIVE_COMPARATOR

Akatinol Memantine 10 mg

Intervention Type: DRUG

Akatinol Memantine 10 mg to be taken orally, twice daily

Interventions

Akatinol Memantine 20 mg

Akatinol Memantine 20 mg to be taken orally, once daily, in the same time of the day

Intervention Type: DRUG

Akatinol Memantine 10 mg

Akatinol Memantine 10 mg to be taken orally, twice daily

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LLC Merz Pharma, Russia

UNKNOWN

Sponsor Role: collaborator

Merz Pharmaceuticals GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Merz Russia Medical Expert

Role: STUDY_DIRECTOR

Merz Russia

Locations

Federal State Budgetary Scientific Institution "Mental Health Research Center"

Moscow, , Russia

Federal State Autonomous Institution of Higher Learning "Peoples' Friendship University of Russia", Medical Institute

Moscow, , Russia

Scientific Research Institute of Neurology, Merz Investigational Site #0070008

Moscow, , Russia

Federal state budgetary military educational institution of higher education "Military Medical Academy named after S.M. Kirov" of the Ministry of defence of the Russian Federation

Saint Petersburg, , Russia

Countries

Russia

Other Identifiers

M900011005

Identifier Type: -

Identifier Source: org_study_id