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

Materia Medica

Status: Completed

Conditions: Chronic Cerebral Ischemia

Treatments: Drug: Divaza

Study type: Observational

Funder types: Industry

Identifiers

NCT04370028

DIAMANT

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,583 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

2,583 participants in 1 patient group

Divaza

Description:

Oral administration. 2 tablet 3 times daily. Keep the tablets in the mouth until completely dissolved, outside of meal.

Treatment:

Drug: Divaza