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出境医 / 临床实验 / Local Study of Akatinol Memantine in VaD in Russia (MIND)

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

Study Description
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

Study Design
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 : July 2021
Arms and Interventions
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
Outcome Measures
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


Eligibility Criteria
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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.
Contacts and Locations

Contacts
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Contact: Maria Kachanova, MD, PhD +74956538555 ext 318 Maria.Kachanova@merz.ru

Locations
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Russian Federation
Federal State Budgetary Scientific Institution "Mental Health Research Center" Active, not 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
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Study Director: Merz Russia Medical Expert Merz Russia
Tracking Information
First Submitted Date  ICMJE June 11, 2019
First Posted Date  ICMJE June 14, 2019
Last Update Posted Date May 24, 2021
Actual Study Start Date  ICMJE January 23, 2018
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2019) 		Change from baseline in total ADAS-cog score points [ Time Frame: 24 weeks ]
ADAS-cog - Alzheimer's Disease Assessment scale, cognitive subscale
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Local Study of Akatinol Memantine in VaD in Russia
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Vascular Dementia
Intervention  ICMJE
  • Drug: Akatinol Memantine 20 mg
    Akatinol Memantine 20 mg to be taken orally, once daily, in the same time of the day
  • Drug: Akatinol Memantine 10 mg
    Akatinol Memantine 10 mg to be taken orally, twice daily
Study Arms  ICMJE
  • Experimental: Akatinol Memantine 20 mg
    Akatinol Memantine 20 mg once daily
    Intervention: Drug: Akatinol Memantine 20 mg
  • Active Comparator: Akatinol Memantine 10 mg
    Akatinol Memantine 10 mg twice daily
    Intervention: Drug: Akatinol Memantine 10 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 11, 2019) 		126
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Maria Kachanova, MD, PhD +74956538555 ext 318 Maria.Kachanova@merz.ru
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03986424
Other Study ID Numbers  ICMJE M900011005
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Merz Pharmaceuticals GmbH
Study Sponsor  ICMJE Merz Pharmaceuticals GmbH
Collaborators  ICMJE LLC Merz Pharma, Russia
Investigators  ICMJE
Study Director: Merz Russia Medical Expert Merz Russia
PRS Account Merz Pharmaceuticals GmbH
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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