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

Chronic Cerebral Ischemia Clinical Trial

— DIAMANT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04370028
• Other study ID #: DIAMANT
• Status: Completed
• Start date: October 2016
• Est. completion date: January 2017

Study information

• Verified date: April 2020
• Source: Materia Medica Holding
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2583
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Ischemia
• Cerebral Infarction
• Chronic Cerebral Ischemia
• Cognition Disorders
• Ischemia

Intervention

Drug:
• Divaza
Oral administration.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Materia Medica Holding

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Relationship Between Cognitive Impairment and Patients' Gender	Evaluation of the relationship between baseline MoCA test results and gender. MoCA - Montreal Cognitive Assessment (0-30 scores, higher scores mean a better outcome)	Data measured at baseline
Other	The Relationship Between Cognitive Impairment and Regional Social/Economic Factors	Evaluation of the relationship between baseline MoCA test results and regional developmental social or economic indicators (poverty, infant mortality, migration, life expectancy, innovation rate, professional development, number of university students, number of R&D personnel, resources spent on R&D, number of doctors, number of hospitals and outpatient clinics, hospital capacity, fertility rate, quality of life index,income).; Relevance of factors (unitless value) provided. The higher the more influential the factor is.; Relevance was assessed with Boruta approach: KURSA, Miron B.; RUDNICKI, Witold R.. Feature Selection with the Boruta Package. Journal of Statistical Software, [S.l.], v. 36, Issue 11, p. 1 - 13, sep. 2010. ISSN 1548-7660. Available at:	Data measured at baseline
Primary	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	week 1 to 12 week
Secondary	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)	12 week
Secondary	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)	week1 to week 12
Secondary	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)	week1 to week 12
Secondary	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)	week1 to week 12