Effect of FGUE on the Mild Cognitive Impairment for the Efficacy and Safety; A 12week, Multi-center, Randomized, Double-blind, Placebo-Controlled Clinical Trial
- Conditions
- Mental and behavioral disorders
- Registration Number
- KCT0003016
- Lead Sponsor
- Kyung Hee University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
A person who complain of memory loss and demonstrate a decrease of 1.0 SD or more on CERAD-K (Consortium to Establish a Registry for Alzheimer's Disease-Korean version)
- People who are currently suffering from schizophrenia or have a history of schizophrenia
- People who have major depressive disorders categorized by DSM-V(The Diagnostic and Statistical Manual of Mental Disorders , Fifth Edition)
- People who have poor cognitive function and have Alzheimer’s disease, Parkinson’s disease, or stroke. (The diagnosis of Alzheimer’s disease is based on DSM-V)
- People who have taken medications for Alzheimer’s disease or other cognitive function problems within 4 weeks prior to the first visit of the study. The examples of the medications are Antipsycotics, Neurodegenerative Disease Drugs, Nootropics & Neurotonics, and tricyclic antidepressant.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in the scores of ADAS-cog(Cognitive subscale of the ADAS) between baseline and after 12 weeks of the treatment
- Secondary Outcome Measures
Name Time Method Changes in the scores of ADAS-cog(Cognitive subscale of the ADAS) memory between baseline and after 12 weeks of the treatment;Changes in the scores of ADAS-K(Alzheimer’s Disease Assessment Scale-Korean version) between baseline and after 12 weeks of the treatment;Changes in the scores of Visual C.P.T(Visual continuous performance test) between baseline and after 12 weeks of the treatment;Changes in the scores of ADCS-ADL(Alzheimer’s Disease Cooperative Study-Activities of Daily Living) between baseline and after 12 weeks of the treatment;Changes in the scores of SGDS(Short form of Geriatric Depression Scale)? Sheikh? Yesavage) between baseline and after 12 weeks of the treatment