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
Intervention: MMH-MAP; Placebo
Intervention description: Oral administration; Oral administration
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 276.0
Sex: All
Minimum age: 45 Years
Maximum age: 80 Years
Healthy volunteers: No

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
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients of either sex, aged 45 to 80 years old inclusively.

          2. Patients with a history of one stroke sustained 3 to 6 months prior to study entry and
             confirmed by neuroimaging.

          3. Patients with cognitive impairment (MoCA score < 26).

          4. Patients with moderate performance in activities of daily living (Barthel score =
             61-80).

          5. Agreement to use a reliable method of birth control for the duration of the study (men
             and women of reproductive potential).

          6. Availability of signed patient information sheet (Informed Consent form) for
             participation in the clinical trial.

        Exclusion Criteria:

          1. Patients with a history of subarachnoid/parenchymatous/ventricular hemorrhage, brain
             neoplasm, or any other condition which has caused neurological dysfunction.

          2. History of central nervous system (CNS) disorders, including:

               -  inflammatory diseases of the CNS (G00-G09)

               -  systemic atrophies primarily affecting the CNS (G10-G13)

               -  extrapyramidal and movement disorders (G20-G26)

               -  other degenerative diseases of the nervous system (G30-G32)

               -  demyelinating diseases of the CNS (G35-G37)

               -  epilepsy (G40-41)

               -  polyneuropathies and other disorders of the peripheral nervous system (G60-64),
                  with marked movement and/or sensory impairments that cause movement disorders

               -  diseases of neuromuscular junction and muscle (G70-73)

               -  hydrocephalus (G91)

               -  compression of brain (G93.5).

          3. Dementia (20 or less on the MMSE score).

          4. Speech disorders affecting investigator-patient communication.

          5. Prior diagnosis of heart failure defined by the New York Heart Association
             classification (1964) as IV Functional Classification or poorly treated hypothyroidism
             or diabetes mellitus.

          6. Patients having unstable angina or myocardial infarction in the past 6 months.

          7. History/suspicion of oncology of any location (except for benign neoplasms).

          8. Any other co-morbidity which, in the opinion of the investigator, may affect patient
             participation in the clinical trial.

          9. Patients allergic to/intolerant of any components of the study treatment.

         10. Patients with hereditary lactose intolerance.

         11. Malabsorption syndrome, including congenital or acquired lactase deficiency (or any
             other disaccharidase deficiency) and galactosemia.

         12. Pregnancy, breast-feeding or unwillingness to use birth control during the study.

         13. Patients who, from the investigator's point of view, will not comply with the
             observation requirements of the study or adhere to study drug dosing regimens.

         14. Patients with a history of non-adherence to medication; mental disorder (except for
             cognitive deficits); or alcoholism or abuse of psychoactive substances, which, in the
             investigator's opinion, will compromise compliance with study procedures.

         15. Patients who have used medications listed in 'Prohibited Concomitant Treatment' in the
             past week.

         16. Participation in other clinical trials in the previous 3 months.

         17. Patients who are related to any of the on-site research personnel directly involved in
             the conduct of the trial or are an immediate relative of the study investigator.
             'Immediate relative' means husband, wife, parent, son, daughter, brother, or sister
             (regardless of whether they are natural or adopted).

         18. Patients who work for MATERIA MEDICA HOLDING (i.e. the company's employees, temporary
             contract workers, appointed officials responsible for carrying out the research or
             immediate relatives of the aforementioned).