This was an open-label, randomized, comparative, parallel group study to investigate the efficacy and safety of the drug in patients with mild cognitive impairment associated with neuropsychiatric symptoms.
The study was aimed to prove that clinical efficacy of the investigational drug by Evalar is at least equal to the efficacy of the reference drug by a foreign manufacturer. Six sites in Russia took part in the study screening 240 patients. 216 subjects were randomized into two equal groups. Patients enrolled were men and women aged 55-75, diagnosed with mild cognitive impairment and having no other current or relapsing psychiatric disorders followed by cognitive deterioration.
In this project, OCT was responsible for reviewing and editing the Clinical Trial Protocol, Investigator’s Brochure and Informed Consent Form, preparing the study manuals and guidelines, managing all aspects of study safety as well as managing investigative sites and the study in general.
All aims of the clinical trial were reached; the project was carried out on time. OCT’s medical writers and biostatisticians prepared the final report for the submission to the Ministry of Healthcare. Going forward, the sponsor plans to receive marketing authorization for the investigated drug.