Trials Sponsors Conditions Drugs Pricing

Conditions

Chronic Cerebral Ischemia

Outcome Measures

Primary Outcomes (1)

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 Outcomes (4)

The Number of Patients With a MoCA Score <26 at 12 Week
12 week
The Number of Patients With a MoCA Score ≤ 17 at the End of the 12-week Therapy
week1 to week 12
The Dynamics of Mean MoCA Score in Each Age Group
week1 to week 12
The Number of Patients With a MoCA Score Improvement (Increase in Scores) in Age Groups
week1 to week 12

Other Outcomes (2)

The Relationship Between Cognitive Impairment and Patients' Gender
Data measured at baseline
The Relationship Between Cognitive Impairment and Regional Social/Economic Factors
Data measured at baseline

Study Arms (1)

Divaza

Oral administration. 2 tablet 3 times daily. Keep the tablets in the mouth until completely dissolved, outside of meal.

Drug: Divaza

Interventions

DivazaDrug

Oral administration.

Divaza

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 90 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability 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.

You may qualify if:

Sponsors & Collaborators

Materia Medica Holding
Industrylead

MeSH Terms

Interventions

divaza

Results Point of Contact

Title: Mikhail Putilovskiy, MD, PhD
Organization: OOO NPF Materia Medica Holding

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

2,583 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 28, 2020

First Posted

April 30, 2020

Study Start

October 2016

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Other Outcomes (2)

Study Arms (1)

Divaza

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Results Point of Contact

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Other Outcomes (2)

Study Arms (1)

Divaza

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Results Point of Contact

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record