Trial Outcomes & Findings for Clinical Trial of Efficacy and Safety of MMH-MAP in the Treatment of Cognitive Disorders (NCT NCT04295681)

Last Updated: 2024-10-28

Results Overview

Montreal Cognitive Assessment Scale (The Montreal Cognitive Assessment, MoCA) will be used to identify moderate cognitive impairment, as well as to assess changes in cognitive functions during therapy. The maximum possible number of points is 30; 26 points or more is considered normal. The minimum score is 0, higher score is better.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

246 participants

Primary outcome timeframe

On baseline and on 90th day of the treatment.

Results posted on

2024-10-28

Participant Flow

A total of 246 patients signed informed consent, of which 1 patient was excluded at the screening due to the patient's refusal to complete the MoCA scale.

Participant milestones

Participant milestones
Measure	MMH-MAP Oral administration. 2 tablets twice daily (approximately at the same time). The drug is taken outside a meal (between the meals or 15 min prior to meal or fluid intake). Tablets should be held in the mouth until completely dissolved. The overall duration of treatment is 90 days. MMH-MAP: Oral administration	Placebo Oral administration. For 90 days according to MMH-MAP dosing regimen. Placebo: Oral administration
Overall Study STARTED	123	122
Overall Study COMPLETED	122	119
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	MMH-MAP Oral administration. 2 tablets twice daily (approximately at the same time). The drug is taken outside a meal (between the meals or 15 min prior to meal or fluid intake). Tablets should be held in the mouth until completely dissolved. The overall duration of treatment is 90 days. MMH-MAP: Oral administration	Placebo Oral administration. For 90 days according to MMH-MAP dosing regimen. Placebo: Oral administration
Overall Study Eligibility error	1	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MMH-MAP n=123 Participants Oral administration. 2 tablets twice daily (approximately at the same time). The drug is taken outside a meal (between the meals or 15 min prior to meal or fluid intake). Tablets should be held in the mouth until completely dissolved. The overall duration of treatment is 90 days. MMH-MAP: Oral administration	Placebo n=122 Participants Oral administration. For 90 days according to MMH-MAP dosing regimen. Placebo: Oral administration	Total n=245 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=123 Participants	0 Participants n=122 Participants	0 Participants n=245 Participants
Age, Categorical Between 18 and 65 years	66 Participants n=123 Participants	63 Participants n=122 Participants	129 Participants n=245 Participants
Age, Categorical >=65 years	57 Participants n=123 Participants	59 Participants n=122 Participants	116 Participants n=245 Participants
Age, Continuous	63.6 years STANDARD_DEVIATION 7.4 • n=123 Participants	62.5 years STANDARD_DEVIATION 7.9 • n=122 Participants	63.0 years STANDARD_DEVIATION 7.7 • n=245 Participants
Sex: Female, Male Female	49 Participants n=123 Participants	33 Participants n=122 Participants	82 Participants n=245 Participants
Sex: Female, Male Male	74 Participants n=123 Participants	89 Participants n=122 Participants	163 Participants n=245 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Russia	123 Participants n=123 Participants	122 Participants n=122 Participants	245 Participants n=245 Participants

PRIMARY outcome

Timeframe: On baseline and on 90th day of the treatment.

Outcome measures

Outcome measures
Measure	MMH-MAP n=122 Participants Oral administration. 2 tablets twice daily (approximately at the same time). The drug is taken outside a meal (between the meals or 15 min prior to meal or fluid intake). Tablets should be held in the mouth until completely dissolved. The overall duration of treatment is 90 days.	Placebo n=119 Participants Oral administration. For 90 days according to MMH-MAP dosing regimen.
Average MoCA Score. "90th day of the treatment minus baseline" score difference	3.9 score on a scale Standard Deviation 2.5	2.9 score on a scale Standard Deviation 2.3
Average MoCA Score. Baseline	20.7 score on a scale Standard Deviation 3.5	21.7 score on a scale Standard Deviation 2.4
Average MoCA Score. On 90th day of the treatment	24.6 score on a scale Standard Deviation 2.9	24.5 score on a scale Standard Deviation 3.0

SECONDARY outcome

Timeframe: On baseline, on 12th and on 90th days of the treatment.

Population: The number of completed cases (non-missing data) is indicated.

NIHSS Scale (National Institutes of Health Stroke Scale) is a scale for assessing the severity of neurological disorders of the acute period of ischemic stroke. The NIHSS scale involves the assessment of a neurological condition by generally accepted methods of clinical examination of reflexes, sensory organs, and the patient's level of consciousness. The results range from minimum indicators - normal or close to normal, to maximum - reflect the degree of neurological damage. The score varies between 0 and 42, lower score is better.

Outcome measures

Outcome measures
Measure	MMH-MAP n=122 Participants Oral administration. 2 tablets twice daily (approximately at the same time). The drug is taken outside a meal (between the meals or 15 min prior to meal or fluid intake). Tablets should be held in the mouth until completely dissolved. The overall duration of treatment is 90 days.	Placebo n=119 Participants Oral administration. For 90 days according to MMH-MAP dosing regimen.
Changes in NIHSS Score. Baseline	8.6 score on a scale Standard Deviation 0.8	8.5 score on a scale Standard Deviation 0.7
Changes in NIHSS Score. On 12th day of the treatment	4.9 score on a scale Standard Deviation 2.0	4.8 score on a scale Standard Deviation 1.9
Changes in NIHSS Score. On 90th day of the treatment	3.0 score on a scale Standard Deviation 1.8	2.9 score on a scale Standard Deviation 1.8
Changes in NIHSS Score. "Baseline minus 12th day" score difference	3.6 score on a scale Standard Deviation 1.7	3.7 score on a scale Standard Deviation 1.9
Changes in NIHSS Score. "Baseline minus 90th day" score difference	5.6 score on a scale Standard Deviation 1.7	5.6 score on a scale Standard Deviation 2.0

SECONDARY outcome

Timeframe: On 90th day of the treatment.

Population: The number of completed cases (non-missing data) is indicated.

The modified Rankin scale (mRs 0-1) allows to assess the grade of disability after a stroke. The scale includes five grades of disability: from 0 to 5: 0 - no symptoms, 5 - gross disability; bedridden, fecal and urinary incontinence, need for constant assistance by medical staff.

Outcome measures

Outcome measures
Measure	MMH-MAP n=114 Participants Oral administration. 2 tablets twice daily (approximately at the same time). The drug is taken outside a meal (between the meals or 15 min prior to meal or fluid intake). Tablets should be held in the mouth until completely dissolved. The overall duration of treatment is 90 days.	Placebo n=107 Participants Oral administration. For 90 days according to MMH-MAP dosing regimen.
Percentage of Patients With no Significant Disabilities.	57 Participants	53 Participants

SECONDARY outcome

Timeframe: On 90th day of the treatment period.

Population: The number of completed cases (non-missing data) is indicated.

According to Clinical Global Impression Efficacy Index (CGI-EI).CGI-EI is filled out by an investigator. It is necessary to indicate the level of efficacy of the therapy and the grade of safety of the therapy and circle the index values at the intersection of the selected lines. Evaluation of the response to treatment should take into account both therapeutic efficacy and treatment-related side effects. Side effects score varies from 1 to 4 (lower is better). Therapeutic effect score varies from 1 to 4 (higher is better). The efficacy index is "Therapeutic effect score" divided by "Side effects score", so efficacy index varies from 0.25 to 4 (higher is better).

Outcome measures

Outcome measures
Measure	MMH-MAP n=113 Participants Oral administration. 2 tablets twice daily (approximately at the same time). The drug is taken outside a meal (between the meals or 15 min prior to meal or fluid intake). Tablets should be held in the mouth until completely dissolved. The overall duration of treatment is 90 days.	Placebo n=107 Participants Oral administration. For 90 days according to MMH-MAP dosing regimen.
Therapeutic and Side Effects, Efficacy Index. Therapeutic effect	3.3 score on a scale Standard Deviation 0.6	3.1 score on a scale Standard Deviation 0.7
Therapeutic and Side Effects, Efficacy Index. Side effects	1.2 score on a scale Standard Deviation 0.4	1.2 score on a scale Standard Deviation 0.5
Therapeutic and Side Effects, Efficacy Index. Efficiency index	3.0 score on a scale Standard Deviation 0.8	2.8 score on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: For 90 days of the treatment period.

Based on medical records. Outcome measure represents the amount of participants having at least one adverse event on record.

Outcome measures

Outcome measures
Measure	MMH-MAP n=123 Participants Oral administration. 2 tablets twice daily (approximately at the same time). The drug is taken outside a meal (between the meals or 15 min prior to meal or fluid intake). Tablets should be held in the mouth until completely dissolved. The overall duration of treatment is 90 days.	Placebo n=122 Participants Oral administration. For 90 days according to MMH-MAP dosing regimen.
Presence of Adverse Events (AEs).	32 participants	28 participants

SECONDARY outcome

Timeframe: For 90 days of the treatment period.

Based on medical records. The sequelae of cerebral infarction (severe infections - hospital-acquired pneumonia, uroinfection; deep venous thrombosis, PATE; epileptic episodes).

Outcome measures

Outcome measures
Measure	MMH-MAP n=122 Participants Oral administration. 2 tablets twice daily (approximately at the same time). The drug is taken outside a meal (between the meals or 15 min prior to meal or fluid intake). Tablets should be held in the mouth until completely dissolved. The overall duration of treatment is 90 days.	Placebo n=119 Participants Oral administration. For 90 days according to MMH-MAP dosing regimen.
Percentage of Patients With Complication of Cerebral Infarction.	2 Participants	2 Participants

SECONDARY outcome

Timeframe: For 90 days of the treatment period.

Based on medical records. Frequency of all-cause mortality outcomes.

Outcome measures

Outcome measures
Measure	MMH-MAP n=122 Participants Oral administration. 2 tablets twice daily (approximately at the same time). The drug is taken outside a meal (between the meals or 15 min prior to meal or fluid intake). Tablets should be held in the mouth until completely dissolved. The overall duration of treatment is 90 days.	Placebo n=119 Participants Oral administration. For 90 days according to MMH-MAP dosing regimen.
Death Rate.	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Visit 1 (day 1), Visit 2 (day 12), and Visit 4 (day 90).

Based on medical records. Vital signs will be measured in a medical setting.

Outcome measures

Outcome measures
Measure	MMH-MAP n=123 Participants Oral administration. 2 tablets twice daily (approximately at the same time). The drug is taken outside a meal (between the meals or 15 min prior to meal or fluid intake). Tablets should be held in the mouth until completely dissolved. The overall duration of treatment is 90 days.	Placebo n=122 Participants Oral administration. For 90 days according to MMH-MAP dosing regimen.
Changes in Vital Signs (Pulse Rate (Heart Rate)). Visit 1 (day 1)	74.0 beats per minute Standard Deviation 7.6	73.5 beats per minute Standard Deviation 7.6
Changes in Vital Signs (Pulse Rate (Heart Rate)). Visit 2 (day 12)	71.3 beats per minute Standard Deviation 5.4	71.3 beats per minute Standard Deviation 6.3
Changes in Vital Signs (Pulse Rate (Heart Rate)). Visit 4 (day 90)	72.3 beats per minute Standard Deviation 6.1	71.4 beats per minute Standard Deviation 5.4

SECONDARY outcome

Timeframe: Visit 1 (day 1), Visit 2 (day 12), and Visit 4 (day 90)

Based on medical records. Vital signs will be measured in a medical setting.

Outcome measures

Outcome measures
Measure	MMH-MAP n=123 Participants Oral administration. 2 tablets twice daily (approximately at the same time). The drug is taken outside a meal (between the meals or 15 min prior to meal or fluid intake). Tablets should be held in the mouth until completely dissolved. The overall duration of treatment is 90 days.	Placebo n=122 Participants Oral administration. For 90 days according to MMH-MAP dosing regimen.
Changes in Vital Signs (Respiration Rate (Breathing Rate)). Visit 1 (day 1)	16.8 breaths per minute Standard Deviation 1.0	16.8 breaths per minute Standard Deviation 0.9
Changes in Vital Signs (Respiration Rate (Breathing Rate)). Visit 2 (day 12)	16.7 breaths per minute Standard Deviation 1.0	16.7 breaths per minute Standard Deviation 0.9
Changes in Vital Signs (Respiration Rate (Breathing Rate)). Visit 4 (day 90)	16.8 breaths per minute Standard Deviation 1.1	16.8 breaths per minute Standard Deviation 1.0

SECONDARY outcome

Timeframe: Visit 1 (day 1), Visit 2 (day 12), and Visit 4 (day 90).

Based on medical records. Vital signs are measured in a medical setting. Systolic blood pressure (SBP) and diastolic blood pressure (DBP) are presented.

Outcome measures

Outcome measures
Measure	MMH-MAP n=123 Participants Oral administration. 2 tablets twice daily (approximately at the same time). The drug is taken outside a meal (between the meals or 15 min prior to meal or fluid intake). Tablets should be held in the mouth until completely dissolved. The overall duration of treatment is 90 days.	Placebo n=122 Participants Oral administration. For 90 days according to MMH-MAP dosing regimen.
Changes in Vital Signs (Blood Pressure). DBP/Visit 1 (day 1)	82.9 mmHg Standard Deviation 7.0	83.5 mmHg Standard Deviation 7.0
Changes in Vital Signs (Blood Pressure). SBP/Visit 1 (day 1)	139 mmHg Standard Deviation 12.6	139.0 mmHg Standard Deviation 11.2
Changes in Vital Signs (Blood Pressure). SBP/Visit 2 (day 12)	129 mmHg Standard Deviation 8.3	130 mmHg Standard Deviation 7.5
Changes in Vital Signs (Blood Pressure). SBP/Visit 4 (day 90)	129 mmHg Standard Deviation 7.7	130 mmHg Standard Deviation 7.8
Changes in Vital Signs (Blood Pressure). DBP/Visit 2 (day 12)	80.0 mmHg Standard Deviation 5.5	80.6 mmHg Standard Deviation 5.7
Changes in Vital Signs (Blood Pressure). DBP/Visit 4 (day 90)	80.2 mmHg Standard Deviation 5.3	80.0 mmHg Standard Deviation 6.2

SECONDARY outcome

Timeframe: On baseline and on 90th day of the treatment.

Based on medical records. Laboratory tests include the following parameters (absolute and relative values): hematology, biochemistry and urinalysis. Laboratory tests will be made by central laboratory. Hemoglobin: less than or equal to (\<=) 115 grams per liter (g/L); greater than or equal to (\>=)185 g/L; decreased from baseline (DFB) \>=20 g/L Hematocrit: \<=0.37 volume/volume (v/v); \>=0.55 v/v Erythrocytes: \>=6 Tera/L Leukocytes: \>=16.0 Giga/L Neutrophils: \<1.0 Giga/L (B); Lymphocytes: greater than (\>) 4.0 Giga/L Monocytes: \>0.7 Giga/L Basophils: \>0.1 Giga/L Eosinophils: \>0.5 Giga/L or \>upper limit of normal (ULN) (if ULN \>=0.5 Giga/L) Sodium: \<=129 millimoles (mmol)/L; \>=160 mmol/L Potassium: \<3 mmol/L; \>=5.5 mmol/L Alanine Aminotransferase (ALT): \>3 ULN Aspartate aminotransferase (AST): \>3 ULN Alkaline phosphatase: \>1.5 ULN Bilirubin: \>1.5 ULN Creatinine: \>=150 micromoles per liter (mcmol/L); \>=30% change from baseline.

Outcome measures

Outcome measures
Measure	MMH-MAP n=123 Participants Oral administration. 2 tablets twice daily (approximately at the same time). The drug is taken outside a meal (between the meals or 15 min prior to meal or fluid intake). Tablets should be held in the mouth until completely dissolved. The overall duration of treatment is 90 days.	Placebo n=122 Participants Oral administration. For 90 days according to MMH-MAP dosing regimen.
Percentage of Patients With Clinically Significant Abnormal Laboratory Data. Baseline	19 Participants	16 Participants
Percentage of Patients With Clinically Significant Abnormal Laboratory Data. On 90th day of the treatment	2 Participants	1 Participants

SECONDARY outcome

Timeframe: For 90 days of the treatment period.

The percentage of patients with recurrent cerebral infarction for 90 days of the treatment period is estimated from medical records.

Outcome measures

Outcome measures
Measure	MMH-MAP n=122 Participants Oral administration. 2 tablets twice daily (approximately at the same time). The drug is taken outside a meal (between the meals or 15 min prior to meal or fluid intake). Tablets should be held in the mouth until completely dissolved. The overall duration of treatment is 90 days.	Placebo n=119 Participants Oral administration. For 90 days according to MMH-MAP dosing regimen.
Percentage of Patients With Recurring Cerebral Infarction.	2 Participants	1 Participants

Adverse Events

MMH-MAP

Serious events: 4 serious events

Other events: 32 other events

Deaths: 0 deaths

Placebo

Serious events: 4 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MMH-MAP n=123 participants at risk Oral administration. 2 tablets twice daily (approximately at the same time). The drug is taken outside a meal (between the meals or 15 min prior to meal or fluid intake). Tablets should be held in the mouth until completely dissolved. The overall duration of treatment is 90 days. MMH-MAP: Oral administration	Placebo n=122 participants at risk Oral administration. For 90 days according to MMH-MAP dosing regimen. Placebo: Oral administration
Nervous system disorders Recurrent stroke	0.81% 1/123 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 90 days, as well as for 24 hours after the last dose of the study drug.	0.00% 0/122 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 90 days, as well as for 24 hours after the last dose of the study drug.
Nervous system disorders Transient ischemic attack	0.81% 1/123 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 90 days, as well as for 24 hours after the last dose of the study drug.	0.00% 0/122 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 90 days, as well as for 24 hours after the last dose of the study drug.
Infections and infestations Nosocomial pneumonia	0.81% 1/123 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 90 days, as well as for 24 hours after the last dose of the study drug.	0.00% 0/122 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 90 days, as well as for 24 hours after the last dose of the study drug.
Injury, poisoning and procedural complications Hematoma as a complication of the procedure	0.81% 1/123 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 90 days, as well as for 24 hours after the last dose of the study drug.	0.00% 0/122 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 90 days, as well as for 24 hours after the last dose of the study drug.
Infections and infestations Pneumonia caused by coronavirus infection COVID-19	0.81% 1/123 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 90 days, as well as for 24 hours after the last dose of the study drug.	1.6% 2/122 • Number of events 2 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 90 days, as well as for 24 hours after the last dose of the study drug.
Metabolism and nutrition disorders Decompensated diabetes mellitus	0.00% 0/123 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 90 days, as well as for 24 hours after the last dose of the study drug.	0.82% 1/122 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 90 days, as well as for 24 hours after the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/123 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 90 days, as well as for 24 hours after the last dose of the study drug.	0.82% 1/122 • Number of events 1 • Registration of AEs begins after taking the first dose of the study drug, continues throughout the entire period of study therapy - 90 days, as well as for 24 hours after the last dose of the study drug.

Other adverse events

Additional Information

Mikhail Putilovskiy, MD, PhD, Clinical and Medical Department Director

MATERIA MEDICA HOLDING

Phone: +74952761571

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place