Chronic Cerebral IschemiaDIAMANTNCT04370028
Study on Efficacy and Safety of Divaza in Patients With Chronic Cerebral Ischemia and Cognitive Disorders
An observational study of Chronic Cerebral Ischemia, run by Materia Medica Holding.
Trial summary
An open-label, prospective, observational, multicenter study. The study enrolls adult outpatients with CCI from 8 federal districts of the Russian Federation. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Cerebral Ischemia
- What is being tested?
- Divaza
- Type of treatment
- Pill or oral medicine
- How many people
- 2,583 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Jan 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Cerebral Ischemia
- Being tested
- Divaza
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DivazaDrug
Oral administration.
| Study group | Role | What they receive |
|---|---|---|
| Divaza | Oral administration. 2 tablet 3 times daily. Keep the tablets in the mouth until completely dissolved, outside of meal. Receives: Drug: Divaza |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: week 1 to 12 week
Secondary outcomes (4)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: week1 to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study startOct 2016
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Cerebral IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,583 participants (actual)
Sponsor and investigators
- Lead sponsor
- Materia Medica Holding
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04370028
- Sponsor's protocol ID
- DIAMANT
- Acronym
- DIAMANT
- Status last verified
- Apr 2020
- First submitted
- 28 Apr 2020
- Last updated
- 10 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- All-Russian Observational Non-interventional Study on Efficacy and Safety of Divaza in Patients With Chronic Cerebral Ischemia and Cognitive Disorders
- ClinicalTrials.gov ID
- NCT04370028
- Acronym / sponsor ID
- DIAMANT / DIAMANT
- Conditions
- Chronic Cerebral Ischemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,583 participants (actual)
- Lead sponsor
- Materia Medica HoldingIndustry (pharma, biotech, devices)
- Study start
- Oct 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 30 Apr 2020 (actual)
- Results
- Posted 10 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Divaza | – | Drug: DivazaOral administration. 2 tablet 3 times daily. Keep the tablets in the mouth until completely dissolved, outside of meal. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DivazaOral administration. | Drug | Divaza |
Primary outcome
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
4 secondary outcomes
The Number of Patients With a MoCA Score <26 at 12 Week
Time frame: 12 week
The Number of Patients With a MoCA Score ≤ 17 at the End of the 12-week Therapy
Time frame: week1 to week 12
The Dynamics of Mean MoCA Score in Each Age Group
Time frame: week1 to week 12
The Number of Patients With a MoCA Score Improvement (Increase in Scores) in Age Groups
Time frame: week1 to week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Cerebral Ischemia, run by Materia Medica Holding.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean MoCA Score at Week 1 and the End of the 12-week Therapy (time frame: week 1 to 12 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.