Cognitive DisordersPhase 3NCT04295681
Clinical Trial of Efficacy and Safety of MMH-MAP in the Treatment of Cognitive Disorders
A Phase 3 study testing MMH-MAP in people with Cognitive Disorders, run by Materia Medica Holding at 22 sites in Russia.
Trial summary
The clinical trial to valuate efficacy and safety of MMH-MAP in the treatment of cognitive disorders in patients with ischemic stroke in the carotid arteries. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Cognitive Disorders
- 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
- 246 participants
- Where
- 22 sitesRussia
- Study dates
- 12 Dec 2019to 7 Feb 2023
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 40 and 75 years old inclusively.
- Ischemic stroke in the carotid arteries (I 63) within 72 hours post debut.
- Moderate cognitive disorders (MoCA < 26).
- Normal consciousness (Glasgow score 15)
- Stroke severity 8-12 according to NIHSS.
- Disability mRs score 2-3.
Show all 9Show fewer
- Availability of cerebral CT/MRI within 72 hours post stroke debut.
- Patients who agreed to use a reliable method of contraception during the study.
- Patients who have signed the Participant Information Sheet and Informed Consent.
Who cannot join
- Current or previous subarachnoidal/parenchymatous/ventricular hemorrhage, cerebral infarction, cerebral tumour.
- Cerebral CT/MRI findings suggesting cerebral hemorrhage, tumour within 72 hours post stroke debut.
- Scheduled or completed thrombolytic therapy for the treatment of the current cerebral infarction.
- Central nervous system (CNS) diseases including:
- Inflammatory diseases of the central nervous system (G00-G09);
- Systemic atrophies primarily affecting the central nervous system (G10-G13);
Show all 26Show fewer
- Extrapyramidal and movement disorders (G20-G26);
- Other degenerative diseases of the nervous system (G30-G32);
- Demyelinating diseases of the CNS (G35-G37);
- Episodic and paroxysmal disorders (G40-G47);
- Polyneuropathies and other disorders of the peripheral nervous system (G60-64), with marked movement and/or sensory impairments that cause movement disorders;
- Hydrocephalus (G91).
- Head injuries (S00-S09) (including history), accompanied by impaired consciousness, brain contusion or open craniocerebral injuries.
- Musculoskeletal disorders causing motor disturbances.
- Dementia (including history) (F00-F03).
- Malignant neoplasms.
- Patients previously diagnosed with class IV heart failure (1964 New York Heart Association functional classification), hypothyroidism, or poorly treated diabetes mellitus.
- Patients having unstable angina or myocardial infarction in the past 6 months.
- Allergy/ intolerance to any of the components of medications used in the treatment.
- Malabsorption syndrome, including congenital or acquired lactase deficiency (or any other disaccharidase deficiency) and galactosemia.
- Any conditions which, according to the investigator opinion, may interfere with the subject's participation in the study.
- Prior history of non-adherence to a drug regimen, a psychiatric disorder, alcoholism or drug abuse, which, in the opinion of the investigator, can compromise compliance with study protocol.
- Pregnancy, breast-feeding; childbirth less than 3 months prior to the inclusion in the trial, unwillingness to use contraceptive methods during the trial.
- Participation in other clinical studies within 3 month prior to enrollment in the study.
- 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 OOO "NPF "Materia Medica Holding" (i.e. the company's employees, temporary contract workers, designated officials responsible for carrying out the research or any immediate relatives of the aforementioned).
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Russia22 sites
The First City Clinical Hospital named after E.E. Volosevich
Arkhangelsk, 163001
Arkhangelsk Regional Clinical Hospital/Neurological Department
Arkhangelsk, 163045
Belgorod Regional Clinical Hospital of St. Joasaph
Belgorod, 308007
Regional Clinical Hospital # 3
Chelyabinsk, 454021
Kazan State Medical University/Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan
Kazan', 420012
Interregional Clinical Diagnostic Center
Kazan', 420101
City Clinical Hospital # 7
Kazan', 420103
Research Institute - Regional Clinical Hospital # 1 named after Prof. S.V. Ochapovsky
Krasnodar, 350086
City Clinical Hospital named after V.M. Buyanov, Moscow Department of Health
Moscow, 115516
Central Clinical Hospital of the Russian Academy of Sciences
Moscow, 117593
City Clinical Hospital # 5 of the Nizhegorodskiy District of Nizhny Novgorod
Nizhny Novgorod, 603005
Novosibirsk State Regional Clinical Hospital
Novosibirsk, 630087
Regional Clinic Hospital/Emergency cardiology unit with intensive care and resuscitation unit
Ryazan, 390039
St. Petersburg Research Institute of Ambulance named after I.I. Janelidze
Saint Petersburg, 192242
City Multidisciplinary Hospital # 2
Saint Petersburg, 194354
Samara City Clinical Hospital # 1 named after N.I. Pirogov/Neurological Department
Samara, 443096
Saratov City Clinical Hospital # 9
Saratov, 410031
Ulyanovsk Regional Clinical Hospital/Neurological Department
Ulyanovsk, 432063
Regional Clinic Hospital/Neurological department for patients with acute cerebrovascular accident
Vladimir, 600023
Voronezh Regional Clinical Hospital # 1
Voronezh, 394066
Vsevolozhsk Clinical Interdistrict Hospital
Vsevolozhsk, 188643
Clinical Hospital # 8/Intensive Care Unit
Yaroslavl, 150030
About this study
Official title: A Multicenter, Double-blind, Randomized, Parallel Group Placebo-controlled Clinical Trial of Efficacy and Safety of MMH-MAP in the Treatment of Cognitive Disorders in Patients With Ischemic Stroke in the Carotid Arteries
The clinical trial to valuate efficacy and safety of MMH-MAP in the treatment of cognitive disorders in patients with ischemic stroke in the carotid arteries.
Read the detailed description
Design: double-blind, randomized, parallel group placebo-controlled clinical study of efficacy and safety of MMH-MAP in the treatment of cognitive disorders in patients with ischemic stroke in the carotid arteries.
The study will enroll hospitalized subjects of either gender aged 40-75 years old with verified diagnosis of ischemic stroke in the carotid arteries within 72 hours post debut having moderate cognitive disorders, moderate neurological deficit.
At Visit 1 (day 1) the subject's complaints and medical history will be collected, objective examination, safety laboratory tests (hematology, serum chemistry, urinalysis) will be performed. The investigator will evaluate the patient's level of consciousness using The Glasgow Coma Scale, intensity of cognitive disorders using The Montreal Cognitive Assessment (МоСА), condition using National Institute of Health Stroke Scale (NIHSS) and The Modified Rankin Scale (mRs). Concomitant therapy will be recorded and changes in cerebral CT/MRI will be evaluated. If the subject meets inclusion criteria and has no exclusion criteria, he/she will be randomized to MMH-MAP or Placebo group. The first dose of the study product should be taken within 72 hours post stroke debut.
At Visit 2 (day 12±3, end of hospitalization period - the last day of hospitalization due to the current stroke) complaints will be collected, objective examination findings will be recorded, monitoring of the prescribed and concomitant therapy will be performed, treatment safety, compliance and stroke severity according to NIHSS will be evaluated.
By the end of hospital therapy the subject will be switched to outpatient therapy with continuation of IMP and medical assistance designed for the treatment of stroke and its sequelae.
At Visit 3 (day 45±7 days) the investigator will make a phone call to the subject evaluating the treatment safety.
At final Visit 4 (day 90±7 days) complaints will be collected, objective examination findings will be recorded, monitoring of the prescribed and concomitant therapy will be performed, treatment safety, compliance, condition according to NIHSS will be evaluated, mRs, Clinical Global Impression Efficacy Index (CGI-EI) will be filled. The investigator will perform MoCA testing. Safety laboratory tests (hematology, serum chemistry, urinalysis) will be carried out.
Throughout the study the patient will receive the treatment approved by the decree of the RF Ministry of Health dated 29.12.2012 No. 740n "On approval of standard of special care in cerebral infarction" except for the products specified in section "Forbidden concomitant therapy".
- Conditions
- Cognitive Disorders
- Being tested
- MMH-MAP, Placebo
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMH-MAPDrug
Also called Prospekta
Oral administration
PlaceboDrug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| MMH-MAP | Experimental | 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. Receives: Drug: MMH-MAP |
| Placebo | Placebo comparator | Oral administration. For 90 days according to MMH-MAP dosing regimen. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average MoCA Score.
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.
Measured: On baseline and on 90th day of the treatment.
Secondary outcomes (11)
Changes in NIHSS Score.
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.
Measured: On baseline, on 12th and on 90th days of the treatment.
Percentage of Patients With no Significant Disabilities.
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.
Measured: On 90th day of the treatment.
Therapeutic and Side Effects, Efficacy Index.
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).
Measured: On 90th day of the treatment period.
Presence of Adverse Events (AEs).
Based on medical records. Outcome measure represents the amount of participants having at least one adverse event on record.
Measured: For 90 days of the treatment period.
Percentage of Patients With Complication of Cerebral Infarction.
Based on medical records. The sequelae of cerebral infarction (severe infections - hospital-acquired pneumonia, uroinfection; deep venous thrombosis, PATE; epileptic episodes).
Measured: For 90 days of the treatment period.
Death Rate.
Based on medical records. Frequency of all-cause mortality outcomes.
Measured: For 90 days of the treatment period.
Changes in Vital Signs (Pulse Rate (Heart Rate)).
Based on medical records. Vital signs will be measured in a medical setting.
Measured: Visit 1 (day 1), Visit 2 (day 12), and Visit 4 (day 90).
Changes in Vital Signs (Respiration Rate (Breathing Rate)).
Based on medical records. Vital signs will be measured in a medical setting.
Measured: Visit 1 (day 1), Visit 2 (day 12), and Visit 4 (day 90)
Changes in Vital Signs (Blood Pressure).
Based on medical records. Vital signs are measured in a medical setting. Systolic blood pressure (SBP) and diastolic blood pressure (DBP) are presented.
Measured: Visit 1 (day 1), Visit 2 (day 12), and Visit 4 (day 90).
Percentage of Patients With Clinically Significant Abnormal Laboratory Data.
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.
Measured: On baseline and on 90th day of the treatment.
Percentage of Patients With Recurring Cerebral Infarction.
The percentage of patients with recurrent cerebral infarction for 90 days of the treatment period is estimated from medical records.
Measured: For 90 days of the treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start12 Dec 2019
- Primary completion7 Feb 2023
- Study completion7 Feb 2023
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 Cognitive DisordersStudies 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
- 246 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
- NCT04295681
- Sponsor's protocol ID
- MMH-MAP-002
- Status last verified
- Jan 2023
- First submitted
- 27 Feb 2020
- Last updated
- 28 Oct 2024
- 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 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Randomized, Parallel Group Placebo-controlled Clinical Trial of Efficacy and Safety of MMH-MAP in the Treatment of Cognitive Disorders in Patients With Ischemic Stroke in the Carotid Arteries
- ClinicalTrials.gov ID
- NCT04295681
- Acronym / sponsor ID
- MMH-MAP-002
- Conditions
- Cognitive Disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Materia Medica HoldingIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2019 (actual)
- Primary completion
- 7 Feb 2023 (actual)
- Study completion
- 7 Feb 2023 (actual)
- First posted
- 4 Mar 2020 (actual)
- Results
- Posted 28 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The clinical trial to valuate efficacy and safety of MMH-MAP in the treatment of cognitive disorders in patients with ischemic stroke in the carotid arteries.
Detailed description
Design: double-blind, randomized, parallel group placebo-controlled clinical study of efficacy and safety of MMH-MAP in the treatment of cognitive disorders in patients with ischemic stroke in the carotid arteries.
The study will enroll hospitalized subjects of either gender aged 40-75 years old with verified diagnosis of ischemic stroke in the carotid arteries within 72 hours post debut having moderate cognitive disorders, moderate neurological deficit.
At Visit 1 (day 1) the subject's complaints and medical history will be collected, objective examination, safety laboratory tests (hematology, serum chemistry, urinalysis) will be performed. The investigator will evaluate the patient's level of consciousness using The Glasgow Coma Scale, intensity of cognitive disorders using The Montreal Cognitive Assessment (МоСА), condition using National Institute of Health Stroke Scale (NIHSS) and The Modified Rankin Scale (mRs). Concomitant therapy will be recorded and changes in cerebral CT/MRI will be evaluated. If the subject meets inclusion criteria and has no exclusion criteria, he/she will be randomized to MMH-MAP or Placebo group. The first dose of the study product should be taken within 72 hours post stroke debut.
At Visit 2 (day 12±3, end of hospitalization period - the last day of hospitalization due to the current stroke) complaints will be collected, objective examination findings will be recorded, monitoring of the prescribed and concomitant therapy will be performed, treatment safety, compliance and stroke severity according to NIHSS will be evaluated.
By the end of hospital therapy the subject will be switched to outpatient therapy with continuation of IMP and medical assistance designed for the treatment of stroke and its sequelae.
At Visit 3 (day 45±7 days) the investigator will make a phone call to the subject evaluating the treatment safety.
At final Visit 4 (day 90±7 days) complaints will be collected, objective examination findings will be recorded, monitoring of the prescribed and concomitant therapy will be performed, treatment safety, compliance, condition according to NIHSS will be evaluated, mRs, Clinical Global Impression Efficacy Index (CGI-EI) will be filled. The investigator will perform MoCA testing. Safety laboratory tests (hematology, serum chemistry, urinalysis) will be carried out.
Throughout the study the patient will receive the treatment approved by the decree of the RF Ministry of Health dated 29.12.2012 No. 740n "On approval of standard of special care in cerebral infarction" except for the products specified in section "Forbidden concomitant therapy".
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-MAPOral 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 | Placebo comparator | Drug: PlaceboOral administration. For 90 days according to MMH-MAP dosing regimen. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age between 40 and 75 years old inclusively.
- Ischemic stroke in the carotid arteries (I 63) within 72 hours post debut.
- Moderate cognitive disorders (MoCA < 26).
- Normal consciousness (Glasgow score 15)
- Stroke severity 8-12 according to NIHSS.
Key exclusion criteria (26 listed)
- Current or previous subarachnoidal/parenchymatous/ventricular hemorrhage, cerebral infarction, cerebral tumour.
- Cerebral CT/MRI findings suggesting cerebral hemorrhage, tumour within 72 hours post stroke debut.
- Scheduled or completed thrombolytic therapy for the treatment of the current cerebral infarction.
- Central nervous system (CNS) diseases including:
- Head injuries (S00-S09) (including history), accompanied by impaired consciousness, brain contusion or open craniocerebral injuries.
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-MAPAlso: ProspektaOral administration | Drug | MMH-MAP |
| PlaceboOral administration | Drug | Placebo |
Primary outcome
Average MoCA Score.
Time frame: On baseline and on 90th day of the treatment.
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.
11 secondary outcomes
Changes in NIHSS Score.
Time frame: On baseline, on 12th and on 90th days of the treatment.
Percentage of Patients With no Significant Disabilities.
Time frame: On 90th day of the treatment.
Therapeutic and Side Effects, Efficacy Index.
Time frame: On 90th day of the treatment period.
Presence of Adverse Events (AEs).
Time frame: For 90 days of the treatment period.
Percentage of Patients With Complication of Cerebral Infarction.
Time frame: For 90 days of the treatment period.
Death Rate.
Time frame: For 90 days of the treatment period.
Changes in Vital Signs (Pulse Rate (Heart Rate)).
Time frame: Visit 1 (day 1), Visit 2 (day 12), and Visit 4 (day 90).
Changes in Vital Signs (Respiration Rate (Breathing Rate)).
Time frame: Visit 1 (day 1), Visit 2 (day 12), and Visit 4 (day 90)
Changes in Vital Signs (Blood Pressure).
Time frame: Visit 1 (day 1), Visit 2 (day 12), and Visit 4 (day 90).
Percentage of Patients With Clinically Significant Abnormal Laboratory Data.
Time frame: On baseline and on 90th day of the treatment.
Percentage of Patients With Recurring Cerebral Infarction.
Time frame: For 90 days of the treatment period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- 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.
22 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 Cognitive Disorders, run by Materia Medica Holding at 22 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 9 inclusion and 26 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 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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 28 Oct 2024). 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?
Average MoCA Score. (time frame: On baseline and on 90th day of the treatment.). 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 28 Oct 2024.