Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
An open-label, prospective, observational, multicenter study. The study enrolls adult outpatients with CCI from 8 federal districts of the Russian Federation.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Divaza | Oral administration. 2 tablet 3 times daily. Keep the tablets in the mouth until completely dissolved, outside of meal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Divaza | Drug | Oral administration. |
|
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
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.
Not provided
Recruitment period: October 2016 January 2017 Location: outpatient clinics from 8 federal districts of the Russian Federation
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Divaza Treatment Group | All enrolled patients received Divaza 2 tablets 3 times per day for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety was assessed using the data of all 2583 patients. Within each efficacy and demographic analysis only complete cases approach was used, therefore the number of patients analyzed in efficacy analysis was fewer than 1876
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Divaza Treatment Group | All participants received Divaza treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age was not reported for 23 patients. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | MoCA scores were not reported in 21 patients at least at one timepoint (excluded from analysis) | Posted | Mean | Standard Deviation | score on a scale | week 1 to 12 week |
|
|
12 weeks
AEs were collected from all patients received a single dose of Divaza according to patient's complaints and physical examination.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Divaza Treatment Group | All enrolled patients received Divaza 2 tablets 3 times per day for 12 weeks |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mikhail Putilovskiy, MD, PhD | OOO NPF Materia Medica Holding | +74952761575 | 302 | PutilovskiyMA@materiamedica.ru |
Not provided
| ID | Term |
|---|---|
| C000610361 | divaza |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
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 |
| Mean |
| Standard Deviation |
| years |
|
| Age, Customized | Age was not reported for 23 patients | Number | participants |
|
| Sex: Female, Male | Within each analysis only complete cases approach was used.Sexual identity of 29 patients was not specified. | Count of Participants | Participants | No |
|
| Baseline MoCA score | MoCA - Montreal Cognitive Assessment (0-30 scores, higher scores mean a better outcome).MoCA test allows to evaluate the presence of cognitive impairment | Baseline MoCA scores were not reported in 21 patients. | Mean | Standard Deviation | units on a scale |
|
|
|
|
| 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) | MoCA scores were not reported in 21 patients at least at one timepoint (excluded from analysis) | Posted | Number | participants | 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) | MoCA scores were not reported in 21 patients at least at one timepoint (excluded from analysis) | Posted | Number | participants | 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) | Patients who did not reported age or both MoCA scores were excluded from analysis | Posted | Mean | Standard Deviation | score on a scale | 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) | Patients who did not reported age or both MoCA scores were excluded from analysis | Posted | Number | participants | week1 to week 12 |
|
|
|
| Other Pre-specified | 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) | Patients who did not reported sex or baseline MoCA score were excluded from analysis | Posted | Mean | Standard Deviation | units on a scale | Data measured at baseline |
|
|
|
|
| Other Pre-specified | 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. | Incomplete data (with respect to used variables) was excluded | Posted | Median | Inter-Quartile Range | unitless feature importance | Data measured at baseline |
|
|
|
| 0 |
| 2,583 |
| 0 |
| 2,583 |
| 17 |
| 2,583 |
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Somnolence | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
Not provided
| week 12 |
|
| <0.01 |
| Mean Difference (Net) |
| 4.74 |
| 2-Sided |
| 95 |
| 4.17 |
| 5.31 |
| Superiority |
| Change of mean MoCA score | ANOVA | <0.01 | Mean Difference (Net) | 4.55 | 2-Sided | 95 | 4.16 | 4.94 | Superiority |
| Change of mean MoCA score | ANOVA | <0.01 | Mean Difference (Net) | 4.49 | 2-Sided | 95 | 3.7 | 5.27 | Superiority |
| Title | Measurements |
|---|---|
|
| Migration index |
|
| Life expectancy |
|
| Professional development index |
|
| Number of R&D personnel |
|
| Hospitals number |
|
| R&D expenditures |
|
| Innovation rate |
|
| Hospitals capacity |
|
| Fertility rate |
|
| QoL index |
|
| Outpatient clinics |
|
| Nursing personnel |
|
| Income level |
|
| University students |
|
| Number of doctors |
|
| shadowMax (reference zero-importance feature) |
|