Study on Efficacy and Safety of Divaza in Patients With Chronic Cerebral Ischemia and Cognitive Disorders

Study Overview
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Brief Summary
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An open-label, prospective, observational, multicenter study. The study enrolls adult outpatients with CCI from 8 federal districts of the Russian Federation.

Detailed Description
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Medical data (demographic and clinical characteristics - diagnosis, MoCA test results) are collected from patients to whom Divaza is prescribed to be taken according to the following regimen: 2 tablets 3 times per day for 12 weeks. Neurologists assess the patients' cognitive functions with MoCA scale before starting therapy with Divaza (visit 1) and 12 weeks after the treatment (visit 2). The efficacy of Divaza for the treatment of cognitive impairment in patients with chronic cerebral ischemia (CCI) is evaluated. Safety is assessed based on the frequency and severity of adverse events. In addition, the relationship between MoCA test performance and gender or regional social and economic factors is evaluated.

Official Title
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All-Russian Observational Non-interventional Study on Efficacy and Safety of Divaza in Patients With Chronic Cerebral Ischemia and Cognitive Disorders

Conditions
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Chronic Cerebral Ischemia

Intervention / Treatment
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* Drug: Divaza


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of either gender aged 18+ years. Diagnosis of chronic cerebral ischemia (CCI) based on the clinical history of underlying vascular disease(atherosclerosis and/or arterial hypertension) and neurological signs. Unchanged basic therapy of CCI and underlying vascular disease for a previous 3 month. Signed informed consent form. Exclusion Criteria: Other neurological diseases. Any known allergy to/intolerance of any constituent of the medication. Pregnancy, breast-feeding. Participation in other clinical trials for 3 months prior to enrollment in this study. The patient is related to the research personnel of the investigative sites that are directly involved in the study, or is the immediate relative of the investigator, or the employee of OOO NPF Materia Medica Holding.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Divaza<br>Oral administration. 2 tablet 3 times daily. Keep the tablets in the mouth until completely dissolved, outside of meal. | Drug: Divaza<br>* Oral administration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean MoCA Score at Week 1 and the End of the 12-week Therapy | MoCA - Montreal Cognitive Assessment (0-30 scores, higher scores mean a better outcome).MoCA test allows to evaluate the presence of cognitive impairment | week 1 to 12 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Patients With a MoCA Score <26 at 12 Week | The number of patients with mild cognitive impairment. MoCA - Montreal Cognitive Assessment (0-30 scores, higher scores mean a better outcome) | 12 week | 
| The Number of Patients With a MoCA Score ≤ 17 at the End of the 12-week Therapy | The number of patients with dementia. MoCA - Montreal Cognitive Assessment (0-30 scores, higher scores mean a better outcome) | week1 to week 12 | 
| The Dynamics of Mean MoCA Score in Each Age Group | Age groups:young <35 yo, middle-aged - 35-59 yo, elderly - 60-75 yo, senile - 75-90 yo MoCA - Montreal Cognitive Assessment (0-30 scores, higher scores mean a better outcome) | week1 to week 12 | 
| The Number of Patients With a MoCA Score Improvement (Increase in Scores) in Age Groups | Age groups:young <35 yo, middle-aged - 35-59 yo, elderly - 60-75 yo, senile - 75-90 yo MoCA - Montreal Cognitive Assessment (0-30 scores, higher scores mean a better outcome) | week1 to week 12 |