Local Study of Akatinol Memantine in VaD in Russia

NCT03986424 | Completed Phase 3

• 1 other identifier: M900011005
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• Change from baseline in total ADAS-cog score points

  ADAS-cog - Alzheimer's Disease Assessment scale, cognitive subscale

  24 weeks

Study Arms (2)

Akatinol Memantine 20 mg

EXPERIMENTAL

Akatinol Memantine 20 mg once daily

Drug: Akatinol Memantine 20 mg

Akatinol Memantine 10 mg

ACTIVE COMPARATOR

Akatinol Memantine 10 mg twice daily

Drug: Akatinol Memantine 10 mg

Interventions

Akatinol Memantine 20 mg DRUG

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

Akatinol Memantine 20 mg

Akatinol Memantine 10 mg DRUG

Akatinol Memantine 10 mg to be taken orally, twice daily

Akatinol Memantine 10 mg

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merz Pharmaceuticals GmbH: lead
• LLC Merz Pharma, Russia: collaborator

Study Sites (4)

Federal State Budgetary Scientific Institution "Mental Health Research Center"

Moscow, 115522, Russia

Location

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

Moscow, 117198, Russia

Location

Scientific Research Institute of Neurology, Merz Investigational Site #0070008

Moscow, 125367, Russia

Location

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, 194044, Russia

Location

MeSH Terms

Conditions

Dementia, Vascular

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Dementia; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Merz Russia Medical Expert

  Merz Russia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: June 14, 2019
• Study Start: January 23, 2018
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: July 22, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (4)