MedTrace Logo

Prospekta in the Treatment of Cognitive, Behavioral and Psychiatric Disorders in Patients With Vascular Dementia.

NCT04552041 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 406

Last updated 2024-10-28

Study results available
· View outcomes & findings →

Summary

Study purpose:

\- evaluate clinical efficacy ands afety of Prospekta in the treatment of cognitive, behavioral and psychiatric disorders in patients with vascular dementia.

Study objectives:

* evaluate and compare changes in cognitive functions, in behavioral and in psychiatric dementia symptoms in Prospekta and Placebo groups after 24-weeks of treatment
* evaluate and compare the frequency, severity and causal relationship of adverse events (AEs) with the type of therapy in Prospekta and Placebo groups (including central nervous system AEs during therapy, their relationship with the study drug and other characteristics).

Conditions

  • Vascular Dementia

Interventions

DRUG

Prospekta

Oral administration.

DRUG

Placebo

Oral administration.

Sponsors & Collaborators

  • Materia Medica Holding

    lead INDUSTRY

Principal Investigators

  • Pavel Kamchatnov, professor · V.M. Buyanov Moscow City Clinical Hospital, Moscow, Russia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-03
Primary Completion
2022-09-22
Completion
2022-09-22

Countries

  • Russia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04552041 on ClinicalTrials.gov