Clinical Trial of Efficacy and Safety of MMH-MAP in the Treatment of Mild Cognitive Impairment in Early Recovery Stage After Ischemic Stroke
Condition: Mild Cognitive Impairment; Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is:

        -  to evaluate efficacy of MMH-MAP in the treatment of mild cognitive impairment in
           subjects in early rehabilitation period of ischemic stroke

        -  to evaluate safety of MMH-MAP in the treatment of mild cognitive impairment in subjects
           in early rehabilitation period of ischemic stroke
    

Detailed description: 
      A double-blind, placebo-controlled randomized clinical trial in parallel groups.

      The study patients are subjects of either gender, aged 45-80 years old, after an ischemic
      stroke within 3-6 months prior to enrollment and confirmed by neuroimaging, having mild
      cognitive impairment.

      After the patients provide signed Participant Information Sheet and Informed Consent, they
      will be interviewed for complaints and medical history and undergo physical examination and
      laboratory tests. The doctor will rate the severity of patients' cognitive impairments on the
      Mini Mental State Examination (MMSE) scale and Montreal Cognitive Assessment (MoCA) scale,
      assess their performance in activities of daily living on the Barthel Index scale [Collin C,
      Wade DT, Davies S, Horne V. "The Barthel ADL Index: a reliability study." Int Disability
      Study.1988;10:61-63.], and administer the Stroke Specific Quality of Life Scale (SS-QOL)
      questionnaire [Williams LS, Weinberger M, Harris LE, Clark DO, Biller J. Development of a
      stroke-specific quality of life scale. Stroke 1999 Jul;30(7):1362-9]. Eligible participants
      will have to have moderate cognitive impairments (MMSE score - at least 21 and MoCA - less
      than 26). Therapy received by patients for their co-morbidities and primary diagnosis will be
      recorded. All women of childbearing potential will be administered pregnancy tests.

      If a patient meets all inclusion criteria and does not have any exclusion criteria at Visit
      1, he/she is randomized to one of the two groups: group 1 will receive MMH-MAP at 2 tablets
      twice daily; group 2 will receive Placebo using the study product dosing regimen. The total
      duration of follow-up and treatment will be 28 weeks, which will include 5 additional visits.

      At Visit 2 (Week 4±7 days), the doctor records patients' complaints and physical examination
      data, reviews the progress of study and basic and concomitant therapy, and assesses treatment
      safety and patient compliance with treatment.

      At Visit 3 (Week 8±7 days), Visit 4 (Week 16±7 days), and Visit 5 (Week 24±7 days), the
      doctor assesses patients' cognitive impairments (MoCA) and performance in activities of daily
      living (the Barthel Index). The patients complete the SS-QOL questionnaire.

      At Visit 5 (Week 24±7 days), the doctor will additionally complete the Clinical Global
      Impression Efficacy Index (CGI-EI) scale [Guy W, editor. ECDEU Assessment Manual for
      Psychopharmacology. 1976 Rockville, MD, U.S. Department of Health, Education, and Welfare]
      and collect samples for laboratory testing. The patient stops taking the study drug.

      After four weeks following the end of study therapy patients complete a follow-up visit
      -Visit 6 (Week 28±7 days). The patients are interviewed for complaints and undergo physical
      examination, with a check on their concomitant and primary therapies as well as on the safety
      of study treatment. The doctor assesses patients' cognitive impairments (MoCA) and
      performance in activities of daily living (the Barthel Index) and administers the SS-QOL
      questionnaire.

      The total length of the observation period will be 28 weeks. During the study, symptomatic
      therapy and therapy for underlying chronic conditions are allowed with the exception of the
      drugs indicated in the section "Prohibited Concomitant Treatment".
    

Intervention name(s): MMH-MAP; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration; Oral administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment