Mild Cognitive Impairment
Conditions
Interventions
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.
Sponsors
Hori Tomokatsu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| iADRS(Subject of research) | — |
Secondary
| Measure | Time frame |
|---|---|
| ADAS Cog J ,CDR,WMS-R-J(LM1/LM2),ADCS-ADL-PI(Subject of research,informants) ,MMSE-J,FA(whole brain),MD(whole brain) | — |
Contacts
Public ContactYokotsuka Satoru
I'cros Co., Ltd.
Outcome results
None listed