Efficacy and Safety of M-guard use in patients with Down syndrome: a multicenter, prospective, double-blind,parallel-group study

JRCT ID: jRCTs031230732

Registered date:26/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Down syndrome
• Date of first enrollment: 26/03/2024
• Target sample size: 120
• Study type: Interventional
• Intervention(s): Patients with Down syndrome will be randomized 1:1 in a double-blind fashion to two groups, M-Guard and placebo, and observed for 24 weeks.

Outcome(s)

Primary Outcome

Changes in cognitive and regressive symptoms at 24 weeks of treatment, comparing with the pre-treatment baseline as the baseline, will be determined by the following questionnaire;
Regressive Symptom Checklist for Social Symptoms13

Secondary Outcome

The changes in cognition and regressive symptoms will be assessed using the baseline score before the start of treatment as follows.
(1) The following checklists will be used to assess changes in cognitive and degenerative symptoms at the baseline before the start of treatment.
Regressive Symptom Checklist for Social Symptoms13(at 12 weeks of treatment)
Cognitive Scale for Down Syndrome (CS-DS) Japanese version (at 12 and 24 weeks of treatment)
(2) The following assessments of task performance will be conducted as a baseline before the start of treatment.
Neuropsychological testing: Performance on the Trail Making Test (TMT) (at 12 weeks and 24 weeks after the start of treatment)
(3) The primary endpoint and secondary endpoint (1) will be compared between the M-guard and placebo groups in a group that was judged to be "regressive" by the regression-like symptom checklist at the beginning of the study (Visit 1).

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 40age old
• Gender: Both

Include criteria

1) Patients with Down's syndrome
2) 18 to 40 years of age
3) Patients who understand the explanation of their participation in this study or who voluntarily give their or their surrogate's consent to participate in this study.
4) Patients who are in frequent contact with the subject (at least 10 hours per week) and who are able to accompany the subject to the study site, or have an informant who can be contacted by telephone at designated times.
5) If patients use no supplements recommended for cognitive prevention (curcumin, omega-3 fatty acids, vitamins B1 and B12, etc.), or agree not to change in dosage during study period or agree not to take any new supplements.
6) Patients who are undergoing rehabilitation (occupational therapy, day care, etc.) for the purpose of functional recovery of cognitive function, activities of daily living, etc., and who agree to continue the rehabilitation without change in content and frequency from the time the research food is started to the time the supplement is discontinued.

Exclude criteria

1) Patients with a diagnosis of dementia diseases other than Down's disease or with significant neurological disease affecting the central nervous system, including significant brain infection, Parkinson's disease, or cerebrovascular disease
2) Patients who are currently judged by the Principal Investigator or a cooperating clinician to have a serious or unstable disease, such as hepatic, renal, gastrointestinal, respiratory, endocrine, neurological, immunological, or hematological disease, or who are estimated to have a life expectancy of less than 24 months.
3) Patients with a current diagnosis of schizophrenia or other chronic psychiatric disorder that may affect the assessment of cognition or the ability to complete this study
4) Patients with a history of alcohol or drug dependence (excluding tobacco dependence) within 2 years of enrollment.
5) Patients with a history of clinically significant multiple or severe drug allergies or other serious drug allergies or a history of serious atopic or post-treatment severe hypersensitivity (e.g., severe erythema multiforme, striated immunoglobulin A dermatosis, toxic epidermal necrosis, exfoliative dermatitis)
6) Patients with history of strong allergic reactions to the 4 ingredients of M-Guard (jalapenoic acid powder, alpha-GPC processed food, Enzyme-treated hesperidin, and cinnamon extract powder)
7) Patients with clinically significant abnormalities at the time of enrollment that may affect the study
8) Antidementia drugs, antipsychotic drugs, Chinese herbal medicines that may affect the improvement of cognitive function such as ginseng yoeitou, kami ongatou, hachijihokan, touki-peonyaku-san, tsuritosan, and osokansan, and drugs for cerebral infarction (anti-platelet drugs) that may affect the improvement of cognitive function (cilostazol) , Sleep medication (however, half the minimum dosage Patients who are using EPA:DHA (ethyl icosapentate, ethyl omega-3 fatty acid), a polyunsaturated fatty acid that may affect the improvement of cognitive function
9) Patients who are currently or within 12 weeks prior to the start of study drug administration, enrolled in or participating in a medical research study such as another interventional trial or clinical trial
10) Pregnant, possibly pregnant, within 28 days postpartum, or lactating
11) Other patients who are deemed by the principal investigator or the investigator to be unsuitable for the safe conduct of this study.

Related Information

• Primary Sponsor: Migita Ohsuke
• Secondary Sponsor: Kuroki Yoshikazu
• Source(s) of Monetary Support: Glovia Co., Ltd.