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

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).

Timeline

Start

2020-12-03

Primary completion

2022-09-22

Completion

2022-09-22

Outcome

Met primary endpoint

registry analysis (superiority test); Prospekta vs Placebo; p <0.0001; Wilcoxon (Mann-Whitney) NCT04552041 ↗

Drugs

Indications