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

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Cerebral Ischemia
• Intervention / Treatment: Drug: Divaza

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.

• Study Type: Observational
• Enrollment (Actual): 2583

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Divaza; Oral administration. 2 tablet 3 times daily. Keep the tablets in the mouth until completely dissolved, outside of meal.	Drug: Divaza; Oral administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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: <http://www.jstatsoft.org/v036/i11>. Date accessed: 24 nov. 2020. doi:http://dx.doi.org/10.18637/jss.v036.i11.	Data measured at baseline

Collaborators and Investigators

• Sponsor: Materia Medica Holding

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: April 28, 2020
• First Submitted That Met QC Criteria: April 28, 2020
• First Posted (Actual): April 30, 2020

Study Record Updates

• Last Update Posted (Actual): March 10, 2021
• Last Update Submitted That Met QC Criteria: March 9, 2021
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Infarction; Stroke; Brain Infarction; Brain Ischemia; Ischemia; Cerebral Infarction; Cognition Disorders
• Other Study ID Numbers: DIAMANT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No