Back to resultsLocal Study of Akatinol Memantine in VaD in Russia (MIND)
Primary Purpose
Vascular Dementia
Status
Completed
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
Akatinol Memantine 20 mg
Akatinol Memantine 10 mg
Sponsored by
About this trial
This is an interventional treatment trial for Vascular Dementia
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.
Sites / Locations
- Federal State Budgetary Scientific Institution "Mental Health Research Center"
- Federal State Autonomous Institution of Higher Learning "Peoples' Friendship University of Russia", Medical Institute
- Scientific Research Institute of Neurology, Merz Investigational Site #0070008
- 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
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Akatinol Memantine 20 mg
Akatinol Memantine 10 mg
Arm Description
Akatinol Memantine 20 mg once daily
Akatinol Memantine 10 mg twice daily
Outcomes
Primary Outcome Measures
Change from baseline in total ADAS-cog score points
ADAS-cog - Alzheimer's Disease Assessment scale, cognitive subscale
Secondary Outcome Measures
Full Information
NCT ID
NCT03986424
First Posted
June 11, 2019
Last Updated
July 21, 2022
Sponsor
Merz Pharmaceuticals GmbH
Collaborators
LLC Merz Pharma, Russia
1. Study Identification
Unique Protocol Identification Number
NCT03986424
Brief Title
Local Study of Akatinol Memantine in VaD in Russia
Acronym
MIND
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 23, 2018 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
June 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merz Pharmaceuticals GmbH
Collaborators
LLC Merz Pharma, Russia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Dementia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Akatinol Memantine 20 mg
Arm Type
Experimental
Arm Description
Akatinol Memantine 20 mg once daily
Arm Title
Akatinol Memantine 10 mg
Arm Type
Active Comparator
Arm Description
Akatinol Memantine 10 mg twice daily
Intervention Type
Drug
Intervention Name(s)
Akatinol Memantine 20 mg
Intervention Description
Akatinol Memantine 20 mg to be taken orally, once daily, in the same time of the day
Intervention Type
Drug
Intervention Name(s)
Akatinol Memantine 10 mg
Intervention Description
Akatinol Memantine 10 mg to be taken orally, twice daily
Primary Outcome Measure Information:
Title
Change from baseline in total ADAS-cog score points
Description
ADAS-cog - Alzheimer's Disease Assessment scale, cognitive subscale
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merz Russia Medical Expert
Organizational Affiliation
Merz Russia
Official's Role
Study Director
Facility Information:
Facility Name
Federal State Budgetary Scientific Institution "Mental Health Research Center"
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Federal State Autonomous Institution of Higher Learning "Peoples' Friendship University of Russia", Medical Institute
City
Moscow
ZIP/Postal Code
117198
Country
Russian Federation
Facility Name
Scientific Research Institute of Neurology, Merz Investigational Site #0070008
City
Moscow
ZIP/Postal Code
125367
Country
Russian Federation
Facility Name
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
City
Sankt-Peterburg
ZIP/Postal Code
194044
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Local Study of Akatinol Memantine in VaD in Russia
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