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

NCT04370028 | Completed Results

• 1 other identifier: DIAMANT
• Study Type: observational
• Target: 2,583
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

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

Divaza DRUG

Oral administration.

Divaza

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Materia Medica Holding: lead

MeSH Terms

Interventions

divaza

Results Point of Contact

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

PutilovskiyMA@materiamedica.ru

+74952761575

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: March 10, 2021
• Results First Posted: March 10, 2021

Record last verified: 2020-04