Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03986424
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : July 17, 2019
Sponsor:
Collaborator:
LLC Merz Pharma, Russia
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH

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.

Condition or disease Intervention/treatment Phase
Vascular Dementia Drug: Akatinol Memantine 20 mg Drug: Akatinol Memantine 10 mg Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 23, 2018
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

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




Primary Outcome Measures :
  1. Change from baseline in total ADAS-cog score points [ Time Frame: 24 weeks ]
    ADAS-cog - Alzheimer's Disease Assessment scale, cognitive subscale



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986424


Contacts
Layout table for location contacts
Contact: Maria Kachanova, MD, PhD +74956538555 ext 318 Maria.Kachanova@merz.ru

Locations
Layout table for location information
Russian Federation
Federal State Budgetary Scientific Institution "Mental Health Research Center" Recruiting
Moscow, Russian Federation, 115522
Federal State Autonomous Institution of Higher Learning "Peoples' Friendship University of Russia", Medical Institute Recruiting
Moscow, Russian Federation, 117198
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 Recruiting
Sankt-Peterburg, Russian Federation, 194044
Sponsors and Collaborators
Merz Pharmaceuticals GmbH
LLC Merz Pharma, Russia
Investigators
Layout table for investigator information
Study Director: Merz Russia Medical Expert Merz Russia

Layout table for additonal information
Responsible Party: Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT03986424     History of Changes
Other Study ID Numbers: M900011005
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Dementia
Dementia, Vascular
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Leukoencephalopathies
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Memantine
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents