Mild Cognitive ImpairmentPhase 3NCT03815292
Clinical Trial of Efficacy and Safety of MMH-MAP in the Treatment of Mild Cognitive Impairment in Early Recovery Stage After Ischemic Stroke
A Phase 3 study testing MMH-MAP in people with Mild Cognitive Impairment and Ischemic Stroke, run by Materia Medica Holding at 28 sites in Russia.
Trial 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 Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Mild Cognitive Impairment, Ischemic Stroke
- What is being tested?
- MMH-MAP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 276 participants
- Where
- 28 sitesRussia
- Study dates
- 19 Oct 2018to 27 Jan 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 28Show fewer
- 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.
- Patients having unstable angina or myocardial infarction in the past 6 months.
- History/suspicion of oncology of any location (except for benign neoplasms).
- Any other co-morbidity which, in the opinion of the investigator, may affect patient participation in the clinical trial.
- Patients allergic to/intolerant of any components of the study treatment.
- Patients with hereditary lactose intolerance.
- Malabsorption syndrome, including congenital or acquired lactase deficiency (or any other disaccharidase deficiency) and galactosemia.
- Pregnancy, breast-feeding or unwillingness to use birth control during the study.
- 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.
- 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.
- Patients who have used medications listed in 'Prohibited Concomitant Treatment' in the past week.
- Participation in other clinical trials in the previous 3 months.
- 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).
- 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).
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
Russia28 sites
Arkhangelsk Regional Clinical Hospital
Arkhangelsk, 163045
Belgorod Regional Clinical Hospital of St. Joseph
Belgorod, 308007
Non-State Healthcare Institution "Divisional Hospital at the Bryansk-2 station of the open joint-stock company Russian Railways"
Bryansk, 241004
Bryansk Regional Hospital № 1
Bryansk, 241033
Federal State Budgetary Educational Institution of Higher Education "Kazan Medical University" of the Ministry of Healthcare of the Russian Federation
Kazan', 420012
Scientific-Research Institute - Regional Clinical Hospital №1 named after Professor S.V. Ochapovsky
Krasnodar, 350086
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
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
City Clinical Hospital named after SI. Spasokokukotsky Department of Health of Moscow
Moscow, 127206
City Clinical Hospital №5 of Nizhny Novgorod region of Nizhny Novgorod
Nizhny Novgorod, 603005
Privolzhskiy Research Medical University
Nizhny Novgorod, 603005
State budgetary institution of public health services of the Nizhniy Novgorod region "Nizhegorod Regional Clinical Hospital named after NA Semashko"
Nizhny Novgorod, 603126
Pyatigorsk City Clinical Hospital № 2
Pyatigorsk, 357538
Ryazan State Medical University named after academician I.P. Pavlov
Ryazan, 390026
St. Petersburg I. I. Dzhanelidze Research Institute of Emergency Medicine
Saint Petersburg, 192242
Leningrad Regional Clinical Hospital
Saint Petersburg, 194291
State budgetary institution of health care of the Samara region "Samara City Clinical Hospital № 1 named after NI Pirogov"
Samara, 443096
Republican Clinical Hospital №4
Saransk, 430032
Saratov State Medical University named after V. I. Razumovsky
Saratov, 410012
St. Petersburg State Budgetary Institution "City Hospital No. 40 in the Kurortny District"
Sestroretsk, 197706
Smolensk State Medical University
Smolensk, 214018
State budgetary institution of health care of the Tver region "Regional Clinical Treatment and Rehabilitation Center"
Tver', 170026
State Healthcare Institution Ulyanovsk Regional Clinical Hospital
Ulyanovsk, 432063
State budgetary health care institution of the Vladimir region "Regional Clinical Hospital"
Vladimir, 600023
Volgograd State Medical University
Volgograd, 400131
Voronezh Regional Clinical Hospital № 1
Voronezh, 394066
Vsevolozhsk Clinical Interdistrict Hospital
Vsevolozhsk, 188643
State Institution of Health of the Yaroslavl Region Clinical Hospital No. 8
Yaroslavl, 150030
About this study
Official title: Multicenter Double-blind Placebo-controlled Randomized Parallel-group Clinical Study of Efficacy and Safety of MMH-MAP in the Treatment of Mild Cognitive Impairment in Subjects in Early Rehabilitation Period of Ischemic Stroke
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
Read the 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".
- Conditions
- Mild Cognitive Impairment, Ischemic Stroke
- Being tested
- MMH-MAP, Placebo
- Medical subject headings
- Cognitive Dysfunction, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMH-MAPDrug
Oral administration
PlaceboDrug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: MMH-MAP |
| Placebo | Placebo comparator | Placebo for 24 weeks, according to the MMH-MAP dosing regimen. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks of the treatment as compared to the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start19 Oct 2018
- Primary completion27 Jan 2020
- Study completion27 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Materia Medica Holding
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03815292
- Sponsor's protocol ID
- MMH-MAP-001
- Status last verified
- Aug 2019
- First submitted
- 11 Nov 2018
- Last updated
- 23 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Double-blind Placebo-controlled Randomized Parallel-group Clinical Study of Efficacy and Safety of MMH-MAP in the Treatment of Mild Cognitive Impairment in Subjects in Early Rehabilitation Period of Ischemic Stroke
- ClinicalTrials.gov ID
- NCT03815292
- Acronym / sponsor ID
- MMH-MAP-001
- Conditions
- Mild Cognitive Impairment, Ischemic Stroke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Materia Medica HoldingIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2018 (actual)
- Primary completion
- 27 Jan 2020 (actual)
- Study completion
- 27 Jan 2020 (actual)
- First posted
- 24 Jan 2019 (actual)
- Results
- Posted 23 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MMH-MAP | Experimental | Drug: MMH-MAPTablet 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. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo for 24 weeks, according to the MMH-MAP dosing regimen. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (28 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MMH-MAPOral administration | Drug | MMH-MAP |
| PlaceboOral administration | Drug | Placebo |
Primary outcome
Percentage of Patients With Improved Cognitive Function (The Montreal Cognitive Assessment Test Total Score of the Baseline +1 or More)
Time frame: 24 weeks of the treatment as compared to the baseline
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MMH-MAP in people with Mild Cognitive Impairment and Ischemic Stroke, run by Materia Medica Holding at 28 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients With Improved Cognitive Function (The Montreal Cognitive Assessment Test Total Score of the Baseline +1 or More) (time frame: 24 weeks of the treatment as compared to the baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2021.