Local Study of Akatinol Memantine in VaD in Russia

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Vascular Dementia

Intervention / Treatment
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* Drug: Akatinol Memantine 20 mg
* Drug: Akatinol Memantine 10 mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Akatinol Memantine 20 mg<br>Akatinol Memantine 20 mg once daily | Drug: Akatinol Memantine 20 mg<br>* Akatinol Memantine 20 mg to be taken orally, once daily, in the same time of the day<br>|
| Active Comparator: Akatinol Memantine 10 mg<br>Akatinol Memantine 10 mg twice daily | Drug: Akatinol Memantine 10 mg<br>* Akatinol Memantine 10 mg to be taken orally, twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in total ADAS-cog score points | ADAS-cog - Alzheimer's Disease Assessment scale, cognitive subscale | 24 weeks |