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

Materia Medica Holding2,583 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

2,583

Conditions

Chronic Cerebral Ischemia

Interventions

DivazaDRUG

Oral administration.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients of either gender aged 18+ years. 2. Diagnosis of chronic cerebral ischemia (CCI) based on the clinical history of underlying vascular disease(atherosclerosis and/or arterial hypertension) and neurological signs. 3. Unchanged basic therapy of CCI and underlying vascular disease for a previous 3 month. 4. Signed informed consent form. Exclusion Criteria: 1. Other neurological diseases. 2. Any known allergy to/intolerance of any constituent of the medication. 3. Pregnancy, breast-feeding. 4. Participation in other clinical trials for 3 months prior to enrollment in this study. 5. 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.

Outcomes

Primary Outcomes

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

Time frame: week 1 to 12 week

Secondary Outcomes

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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: week1 to week 12

Data from ClinicalTrials.gov

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