Local Study of Akatinol Memantine in VaD in Russia

Vascular Dementia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03986424
• Other study ID #: M900011005
• Status: Completed
• Phase: Phase 3
• Start date: January 23, 2018
• Est. completion date: June 1, 2022

Study information

• Verified date: July 2022
• Source: Merz Pharmaceuticals GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dementia
• Dementia, Vascular
• Vascular Dementia

Intervention

Drug:
• Akatinol Memantine 20 mg
Akatinol Memantine 20 mg to be taken orally, once daily, in the same time of the day
• Akatinol Memantine 10 mg
Akatinol Memantine 10 mg to be taken orally, twice daily

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Merz Pharmaceuticals GmbH	LLC Merz Pharma, Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in total ADAS-cog score points	ADAS-cog - Alzheimer's Disease Assessment scale, cognitive subscale	24 weeks