Clinical Trial of Efficacy and Safety of MMH-MAP in the Treatment of Mild Cognitive Impairment in Early Recovery Stage After Ischemic Stroke

NCT03815292 | Completed Phase 3 Results

• 1 other identifier: MMH-MAP-001
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 28

Brief 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

Conditions

Mild Cognitive Impairment; Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With Improved Cognitive Function (The Montreal Cognitive Assessment Test Total Score of the Baseline +1 or More)

  MoCa is the test for assessment of cognitive impairment. The score ranges between 0 and 30. A score of 26-30 is normal. A score less than 26 is considered as mild cognitive impairment. Higher values represent a better outcome.

  24 weeks of the treatment as compared to the baseline

Other Outcomes (8)

• Change in MoCA (The Montreal Cognitive Assessment Test) Score

  24 weeks of the treatment as compared to the baseline

• Percentage of Patients With Improved Performance in Activities of Daily Living (Barthel Index Score of the Baseline + 5 or More)

  24 weeks of the treatment as compared to the baseline

• Change in Barthel Index Score

  24 weeks of the treatment as compared to the baseline

Study Arms (2)

MMH-MAP

EXPERIMENTAL

Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in mouth without chewing until complete dissolution. The duration of treatment will be 24 weeks.

Drug: MMH-MAP

Placebo

PLACEBO COMPARATOR

Placebo for 24 weeks, according to the MMH-MAP dosing regimen.

Drug: Placebo

Interventions

MMH-MAP DRUG

Oral administration

MMH-MAP

Placebo DRUG

Oral administration

Placebo

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of either sex, aged 45 to 80 years old inclusively.
• Patients with a history of one stroke sustained 3 to 6 months prior to study entry and confirmed by neuroimaging.
• Patients with cognitive impairment (MoCA score \< 26).
• Patients with moderate performance in activities of daily living (Barthel score = 61-80).
• Agreement to use a reliable method of birth control for the duration of the study (men and women of reproductive potential).
• Availability of signed patient information sheet (Informed Consent form) for participation in the clinical trial.

You may not qualify if:

• Patients with a history of subarachnoid/parenchymatous/ventricular hemorrhage, brain neoplasm, or any other condition which has caused neurological dysfunction.
• 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).
• Dementia (20 or less on the MMSE score).
• Speech disorders affecting investigator-patient communication.
• 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.

Sponsors & Collaborators

• Materia Medica Holding: lead

Study Sites (28)

Arkhangelsk Regional Clinical Hospital

Arkhangelsk, 163045, Russia

Location

Belgorod Regional Clinical Hospital of St. Joseph

Belgorod, 308007, Russia

Location

Non-State Healthcare Institution "Divisional Hospital at the Bryansk-2 station of the open joint-stock company Russian Railways"

Bryansk, 241004, Russia

Location

Bryansk Regional Hospital № 1

Bryansk, 241033, Russia

Location

Federal State Budgetary Educational Institution of Higher Education "Kazan Medical University" of the Ministry of Healthcare of the Russian Federation

Kazan', 420012, Russia

Location

Scientific-Research Institute - Regional Clinical Hospital №1 named after Professor S.V. Ochapovsky

Krasnodar, 350086, Russia

Location

The State Budget Health Care institution of Moscow the City "City clinical hospital No. 12 of the Administration of Health Care of Moscow City"

Moscow, 115516, Russia

Location

State Budgetary Institution of Healthcare of the City of Moscow City Clinical Hospital No. 1 named after. N.I. Pirogov Moscow Department of Health

Moscow, 119049, Russia

Location

City Clinical Hospital named after SI. Spasokokukotsky Department of Health of Moscow

Moscow, 127206, Russia

Location

City Clinical Hospital №5 of Nizhny Novgorod region of Nizhny Novgorod

Nizhny Novgorod, 603005, Russia

Location

Privolzhskiy Research Medical University

Nizhny Novgorod, 603005, Russia

Location

State budgetary institution of public health services of the Nizhniy Novgorod region "Nizhegorod Regional Clinical Hospital named after NA Semashko"

Nizhny Novgorod, 603126, Russia

Location

Pyatigorsk City Clinical Hospital № 2

Pyatigorsk, 357538, Russia

Location

Ryazan State Medical University named after academician I.P. Pavlov

Ryazan, 390026, Russia

Location

St. Petersburg I. I. Dzhanelidze Research Institute of Emergency Medicine

Saint Petersburg, 192242, Russia

Location

Leningrad Regional Clinical Hospital

Saint Petersburg, 194291, Russia

Location

State budgetary institution of health care of the Samara region "Samara City Clinical Hospital № 1 named after NI Pirogov"

Samara, 443096, Russia

Location

Republican Clinical Hospital №4

Saransk, 430032, Russia

Location

Saratov State Medical University named after V. I. Razumovsky

Saratov, 410012, Russia

Location

St. Petersburg State Budgetary Institution "City Hospital No. 40 in the Kurortny District"

Sestroretsk, 197706, Russia

Location

Smolensk State Medical University

Smolensk, 214018, Russia

Location

State budgetary institution of health care of the Tver region "Regional Clinical Treatment and Rehabilitation Center"

Tver', 170026, Russia

Location

State Healthcare Institution Ulyanovsk Regional Clinical Hospital

Ulyanovsk, 432063, Russia

Location

State budgetary health care institution of the Vladimir region "Regional Clinical Hospital"

Vladimir, 600023, Russia

Location

Volgograd State Medical University

Volgograd, 400131, Russia

Location

Voronezh Regional Clinical Hospital № 1

Voronezh, 394066, Russia

Location

Vsevolozhsk Clinical Interdistrict Hospital

Vsevolozhsk, 188643, Russia

Location

State Institution of Health of the Yaroslavl Region Clinical Hospital No. 8

Yaroslavl, 150030, Russia

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Mikhail Putilovskiy, MD, PhD, Clinical and Medical Department Director
• Organization: MATERIA MEDICA HOLDING

PutilovskiyMA@materiamedica.ru

+74952761571

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2018
• First Posted: January 24, 2019
• Study Start: October 19, 2018
• Primary Completion: January 27, 2020
• Study Completion: January 27, 2020
• Last Updated: February 23, 2021
• Results First Posted: February 23, 2021

Record last verified: 2019-08

Locations

RU (28)