Prospecta in the Treatment of Cognitive, Behavioural and Psychiatric Disorders in Patients With Vascular Dementia.
Condition: Vascular Dementia
MeSH terms: Dementia; Dementia, Vascular; Mental Disorders; Problem Behavior
Study type: Interventional
Phase: Phase 3

Summary: 
      Study purpose:

      - evaluate safety and clinical efficacy of Prospecta in the treatment of cognitive,
      behavioural and psychiatric disorders in patients with vascular dementia.

      Study objectives:

        -  evaluate and compare changes in cognitive functions and in behavioural and psychiatric
           dementia symptoms in Prospecta and Placebo groups after 24-week therapy:

        -  evaluate and compare the frequency, severity and causal relationship of adverse events
           (AEs) with the type of therapy in Prospecta and Placebo groups (including central
           nervous system AEs during therapy, their relationship with the product and other
           characteristics).
    

Detailed description: 
      Design: a multicenter double blind placebo-controlled parallel-group randomized clinical
      trial. The study will enroll male and female subjects aged 60-85 years diagnosed with
      vascular dementia (verified at Visit 1 and diagnosed according to the criteria of The
      National Institute of Neurological Disorders and Stroke National Institute of Neurological
      Disorders and Stroke-Association Internationale pour la Recherche et l'Enseignement en
      Neurosciences - NINDS-AIREN). Severity of vascular dementia should be moderate or mild (10-24
      points according to Mini-Mental State Examination - MMSE), without signs of depression (total
      Cornell Scale for Depression in Dementia (CSDD) score ≤10).

      After signing patient information sheet (informed consent form), investigator will collect
      complaints and medical history, perform objective examination, record vital signs (blood
      pressure (BP), respiratory rate (RR), heart rate (HR)) and evaluate the compliance of the
      subject's diagnosis with NINDS-AIREN vascular criteria of dementia (Visit 1; from day -14 to
      day 1). The investigator will assess cognitive disorders using Mini-Mental State Examination
      (MMSE) and Montreal Сognitive Assessment (МоСА). The investigator will fill the
      Neuropsychiatric Inventory Сlinician (NPI-С), and СSDD scales. The subject will undergo brain
      MRI (unless brain MRI was held within the last 12 months prior to enrollment are available).

      Concomitant therapy and concurrent diseases and conditions will be recorded. If subject met
      inclusion criteria, he/she will be randomized to one of the two groups: group 1 will receive
      Prospecta 2 tablets twice daily; group 2 will receive Placebo using the study drug dosing
      regimen.

      Treatment duration will be 24 weeks during which 6 Visits will be made. At visits 2 and 3
      (week 4±3 days and week 8±3 days) the investigator will make a phone call and collect the
      complaints, monitor the prescribed and concomitant therapy, evaluate therapeutic safety.

      At visit 4 (week 12±7 days) the investigator will collect complaints, record objective
      examination findings and vital signs, monitor the prescribed and concomitant therapy,
      evaluate therapeutic safety and compliance, issue the study product until the next visit. The
      investigator will fill MoCA and NPI-C.

      At visits 5 and 6 (week 16±3 days and week 20±3 days) the investigator will make a phone call
      and collect the complaints, monitor the prescribed and concomitant therapy, evaluate
      therapeutic safety.

      At visit 7 (week 24±7 days) the investigator will collect complaints, perform objective
      examination, record vital signs, monitor the prescribed and concomitant therapy, evaluate
      therapeutic safety, evaluate compliance. The investigator will fill MоСА and Clinical Global
      Impression Efficacy Index (CGI-EI). The investigator will fill NPI-C.

      During the study the treatment for underlying medical conditions will be allowed with the
      exception of the drugs indicated in the section "Prohibited concomitant therapy".
    

Intervention name(s): Prospecta; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration.; Oral administration.
Other intervention name(s): MMH-MAP
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: double-blind placebo-controlled randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment