JRCT ID: jRCTs031220284
Registered date:22/08/2022
Efficacy and Safety of M-guard use in MCI patients: a multicenter, prospective, double-blind, parallel-group study
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | Mild Cognitive Impairment |
Date of first enrollment | 14/12/2022 |
Target sample size | 150 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | MCI patients are randomized to the M-guard or placebo group in a double-blind manner at a ratio of 1: 1 and observed for 48 weeks. |
Outcome(s)
Primary Outcome | iADRS(Subject of research) |
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Secondary Outcome | ADAS Cog J ,CDR,WMS-R-J(LM1/LM2),ADCS-ADL-PI(Subject of research,informants) ,MMSE-J,FA(whole brain),MD(whole brain) |
Key inclusion & exclusion criteria
Age minimum | >= 60age old |
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Age maximum | <= 85age old |
Gender | Both |
Include criteria | 1.Age 60 to 85 years at the time informed consent obtained 2.Patients who can obtain document consent with their own will before any study related procedure 3.MMSE score 24 to 28 at screening 4.Reported by patients and/or informants that slowly developing dysmnesia over a period of 6 months or longer. |
Exclude criteria | 1.Patients with dementia other than Alzheimer's disease, serious brain infections, Parkinson's disease, multiple brain shakes, epilepsy and/or recurrent attacks, etc., which may affect cognition and the ability to complete this study, the central nervous system, patients with serious neurological disorders that affect the disease. 2. Patients who currently have serious or unstable diseases such as cardiovascular disease, liver disease, renal disease, digestive system disease, respiratory disease, endocrine disease, neurological disease, immune disease, and blood disease, or an estimated life expectancy of less than 24 months. 3. Patients who have a history of cancer within the last 5 years excluding non-metastatic basal cell carcinoma of the skin and/or squamous cell carcinoma, cervical intraepithelial carcinoma, non-progressive prostate cancer, or other cancers with a low risk of recurrence and metastasis. 4. Patients who currently have a diagnosis of schizophrenia or other chronic psychiatric disorders and may affect cognitive assessment or ability to complete this study. 5. Patients who are prone to depression (GDS-S-J 6 points or higher) and are judged to be at high risk of suicide. |
Related Information
Primary Sponsor | Hori Tomokatsu |
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Secondary Sponsor | |
Source(s) of Monetary Support | Glovia Co., Ltd. |
Secondary ID(s) |
Contact
Public contact | |
Name | Yokotsuka Satoru |
Address | 1-1-1 Tengin,chuoku,Fukuokashi,Fukuokaken Fukuoka Japan 810-0001 |
Telephone | +81-92-406-8278 |
mguard-icros@iromgroup.co.jp | |
Affiliation | I'cros Co., Ltd. |
Scientific contact | |
Name | Tomokatsu Hori |
Address | 7-12 Nishikasai,Edogawaku,Tokyoto Tokyo Japan 134-0088 |
Telephone | +81-3-3675-1211 |
thori@moriyamaikai.or.jp | |
Affiliation | Social Medical Corporation Moriyamaikai Moriyama Neurological Center Hospital |