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Completed

NCT Number: NCT04370028

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.

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Key information

Conditions

Chronic Cerebral Ischemia

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients of either gender aged 18+ years.
  • Diagnosis of chronic cerebral ischemia (CCI) based on the clinical history of underlying vascular disease(atherosclerosis and/or arterial hypertension) and neurological signs.
  • Unchanged basic therapy of CCI and underlying vascular disease for a previous 3 month.
  • Signed informed consent form.

Exclusion criteria

  • Other neurological diseases.
  • Any known allergy to/intolerance of any constituent of the medication.
  • Pregnancy, breast-feeding.
  • Participation in other clinical trials for 3 months prior to enrollment in this study.
  • 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.

Treatment and study plan

Divaza

Drug

Oral administration.

Primary outcomes

  1. Mean MoCA Score at Week 1 and the End of the 12-week Therapy

    Time frame: week 1 to 12 week

    MoCA - Montreal Cognitive Assessment (0-30 scores, higher scores mean a better outcome).MoCA test allows to evaluate the presence of cognitive impairment

Secondary outcomes

  1. The Number of Patients With a MoCA Score <26 at 12 Week

    Time frame: 12 week

    The number of patients with mild cognitive impairment. MoCA - Montreal Cognitive Assessment (0-30 scores, higher scores mean a better outcome)

  2. The Number of Patients With a MoCA Score ≤ 17 at the End of the 12-week Therapy

    Time frame: week1 to week 12

    The number of patients with dementia. MoCA - Montreal Cognitive Assessment (0-30 scores, higher scores mean a better outcome)

  3. The Dynamics of Mean MoCA Score in Each Age Group

    Time frame: week1 to week 12

    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)

  4. The Number of Patients With a MoCA Score Improvement (Increase in Scores) in Age Groups

    Time frame: week1 to week 12

    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)

Other outcomes

  1. The Relationship Between Cognitive Impairment and Patients' Gender

    Time frame: Data measured at baseline

    Evaluation of the relationship between baseline MoCA test results and gender. MoCA - Montreal Cognitive Assessment (0-30 scores, higher scores mean a better outcome)

  2. The Relationship Between Cognitive Impairment and Regional Social/Economic Factors

    Time frame: Data measured at baseline

    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.

Sponsors and collaborators

Lead sponsor

Materia Medica Holding

Industry

Registry information

Official study title

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

Acronym: DIAMANT

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 30, 2020
Registry last updated
Mar 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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