Clinical trial NCT04370028: Study on Efficacy and Safety of Divaza in Patients With Chronic Cerebral Ischemia and Cognitive Disorders
Official title: All-Russian Observational Non-interventional Study on Efficacy and Safety of Divaza in Patients With Chronic Cerebral Ischemia and Cognitive Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Cerebral Ischemia
Lead sponsor: Materia Medica Holding
Sponsor class: INDUSTRY
First posted: 2020-04-30
Enrollment: 2583
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult CCI outpatients with cognitive impairment (MoCA score \<26) or without one (MoCA score ≥ 26) recieving unchanged basic therapy of CCI and underlying vascular disease for a 3 month previous to the onset of the study. Diagnosis of сhronic cerebral ischemia (CCI) was based on the clinical history of underlying vascular disease(atherosclerosis and/or arterial hypertension) and neurological signs. Vascular nature of cognitive impairment in patients with MoCA\<26 was determined according to NINDS-AIREN criteria.

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean MoCA Score at Week 1 and the End of the 12-week Therapy
timeFrame: week 1 to 12 week
Secondary outcomes:
measure: The Number of Patients With a MoCA Score <26 at 12 Week
timeFrame: 12 week
measure: The Number of Patients With a MoCA Score ≤ 17 at the End of the 12-week Therapy
timeFrame: week1 to week 12
measure: The Dynamics of Mean MoCA Score in Each Age Group
timeFrame: week1 to week 12
measure: The Number of Patients With a MoCA Score Improvement (Increase in Scores) in Age Groups
timeFrame: week1 to week 12
Other outcomes:
measure: The Relationship Between Cognitive Impairment and Patients' Gender
timeFrame: Data measured at baseline
measure: The Relationship Between Cognitive Impairment and Regional Social/Economic Factors
timeFrame: Data measured at baseline
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