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

Chronic Cerebral Ischemia Clinical Trial

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

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04370028
Study type	Observational
Source	Materia Medica Holding
Contact
Status	Completed
Phase
Start date	October 2016
Completion date	January 2017

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