At a glance
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Multicenter Double-blind Placebo-controlled Randomized Parallel-group Clinical Trial of Efficacy and Safety of Prospekta in the Treatment of Cognitive, Behavioral and Psychiatric Disorders in Patients With Vascular Dementia.
In Brief
A Phase 3 clinical trial evaluating Prospekta and Placebo for Vascular Dementia. Completed, enrolled 406 participants across 33 sites.
Detailed 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).
Study Details
Timeline
Interventions
Oral administration.
Oral administration.