Effect of HLJG0701 on the Mild Cognitive Impairment for the Efficacy and Safety; A 12week, Randomized, Double-blind, Placebo-Controlled Clinical Trial
- Conditions
- Mental and behavioral disorders
- Registration Number
- KCT0003010
- Lead Sponsor
- Hwajin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
Subject who have decreased CERAD-K(Consortium to Establish a Registry for Alzheimer’s Disease-Korean version) memory score(1.0SD<= and 2.0SD < CERAD-K memory score) comparing to the same age and education group.
- 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 VLT(Verbal learning test) between baseline and after 12 weeks of the treatment;Changes in the scores of NORT(Novel Object Recognition Test) between baseline and after 12 weeks of the treatment;Changes in the scores of Story Recall Test between baseline and after 12 weeks of the treatment;Changes in the scores of Digit span test(Digit span Forward, Digit span Backward) between baseline and after 12 weeks of the treatment
- Secondary Outcome Measures
Name Time Method Changes in the scores of Auditory Continuous Performance Test between baseline and after 12 weeks of the treatment;Changes in the scores of PRMQ(Prospective and Retrospective Memory Questionnaire) between baseline and after 6, 12 weeks of the treatment;Changes in the scores of PSS(Perceived stress Scale) between baseline and after 6, 12 weeks of the treatment;Changes in the scores of BDNF(Brain-Derived Neurotrophic Factor) between baseline and after screening(-2~0), 12 weeks of the treatment