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

Multi-center Open Comparative Randomized Study of Efficacy and Safety of Akatinol Memantine 20 mg (Single-doses) vs. Akatinol Memantine 10 mg (Double-doses) in Patients With Moderate and Moderately Severe Vascular Dementia

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.

Study Overview

• Status: Completed
• Conditions: Vascular Dementia
• Intervention / Treatment: Drug: Akatinol Memantine 20 mg; Drug: Akatinol Memantine 10 mg

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Phase 3

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 115522
    • Federal State Budgetary Scientific Institution "Mental Health Research Center"
  • Moscow, Russian Federation, 117198
    • Federal State Autonomous Institution of Higher Learning "Peoples' Friendship University of Russia", Medical Institute
  • Moscow, Russian Federation, 125367
    • Scientific Research Institute of Neurology, Merz Investigational Site #0070008
  • Sankt-Peterburg, Russian Federation, 194044
    • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Akatinol Memantine 20 mg; Akatinol Memantine 20 mg once daily	Drug: Akatinol Memantine 20 mg; Akatinol Memantine 20 mg to be taken orally, once daily, in the same time of the day
Active Comparator: Akatinol Memantine 10 mg; Akatinol Memantine 10 mg twice daily	Drug: Akatinol Memantine 10 mg; Akatinol Memantine 10 mg to be taken orally, twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in total ADAS-cog score points	ADAS-cog - Alzheimer's Disease Assessment scale, cognitive subscale	24 weeks

Collaborators and Investigators

• Sponsor: Merz Pharmaceuticals GmbH
• Collaborators: LLC Merz Pharma, Russia
• Investigators: Study Director: Merz Russia Medical Expert, Merz Russia

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2018
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: June 11, 2019
• First Submitted That Met QC Criteria: June 11, 2019
• First Posted (Actual): June 14, 2019

Study Record Updates

• Last Update Posted (Actual): July 22, 2022
• Last Update Submitted That Met QC Criteria: July 21, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Neurocognitive Disorders; Intracranial Arterial Diseases; Intracranial Arteriosclerosis; Leukoencephalopathies; Dementia; Dementia, Vascular; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Dopamine Agents; Antiparkinson Agents; Anti-Dyskinesia Agents; Memantine
• Other Study ID Numbers: M900011005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No