Trials / Completed
CompletedNCT04370028
Study on Efficacy and Safety of Divaza in Patients With Chronic Cerebral Ischemia and Cognitive Disorders
All-Russian Observational Non-interventional Study on Efficacy and Safety of Divaza in Patients With Chronic Cerebral Ischemia and Cognitive Disorders
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,583 (actual)
- Sponsor
- Materia Medica Holding · Industry
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
An open-label, prospective, observational, multicenter study. The study enrolls adult outpatients with CCI from 8 federal districts of the Russian Federation.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Divaza | Oral administration. |
Timeline
- Start date
- 2016-10-01
- Primary completion
- 2017-01-01
- Completion
- 2017-01-01
- First posted
- 2020-04-30
- Last updated
- 2021-03-10
- Results posted
- 2021-03-10
Source: ClinicalTrials.gov record NCT04370028. Inclusion in this directory is not an endorsement.