Effects of HX106 on Improvement in Cognitive-Bio-Markers of Memory Function

Study Overview
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Brief Summary
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The objectives of the current study are to evaluate the efficacy and safety of HX106 in healthy adults with subjective memory complaints for improving neurocognitive functions and to find the changes of brain using magnetic resonance imaging and their associations with the neurocognitive function enhancement.

Official Title
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Effects of HX106 on Improvement in Cognitive-Bio-Markers of Memory Function in Healthy Adults With Subjective Memory Complaints: An 8-Week Prospective Randomized Double-Blind Placebo-Controlled Trial With Multimodal Neuroimaging and Neurocognitive Assessments

Conditions
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Healthy Adults With Subjective Memory Complaints

Intervention / Treatment
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* Dietary Supplement: HX106 590mg
* Dietary Supplement: HX106 1180mg
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 20 and 60 years old, Global Deterioration Scale score (GDS) of 2 One or more symptoms of subjective memory impairment High school or higher levels of education. Exclusion Criteria: Current pregnancy or breast-feeding Evidence of neurologic or medical conditions Axis I diagnosis when assessed by the board certified psychiatrist using the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorder, 4th edition (DSM-IV)(SCID-IV), One or more major depressive episode during last 12 months Mini-mental status examination score of 24 or less Clinical Dementia Rating score of 0.5 or more suggesting cognitive impairment beyond self-perceived subjective deficits Intelligence quotient less than 80 Any history of head trauma involving loss of consciousness or seizure Contraindications to magnetic resonance imaging (MRI) Use of psychotropics in last 3 months Use of oral contraceptive medication Participation in other clinical trials during the study period that might affect the outcome of the present study.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HX106 590mg<br>HX106 590mg/day | Dietary Supplement: HX106 590mg<br> <br> |
| Experimental: HX106 1180mg<br>HX106 1180mg/day | Dietary Supplement: HX106 1180mg<br> <br> |
| Placebo Comparator: Placebo<br>Placebo | Dietary Supplement: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes From Baseline in Working Memory Domain Z-score | To assess the working memory performance, four well-established tests, including the symbol span from the Wechsler Memory Scale-IV, immediate recall domain from the Rey-Osterrieth Complex Figure Test, digit span, and letter number sequencing from the Korean version of the Wechsler Adult Intelligence Scale were chosen. Each test score was adjusted with age, sex, intelligent quotient, years of education, and baseline test scores. The adjusted test scores were then standardized into z-scores using all participants' means and standard deviations. The relative improvement (positive z-scores) or decline (negative z-scores) in performance was measured in a unit-free manner using the obtained z-scores. The individual z-scores of each test were averaged to the composite score for working memory domain. | Baseline, 8th week | 
| Changes From Baseline in White Matter Integrity Assessment |  | Baseline, 8th weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events |  | 1st week | 
| Number of Participants With Adverse Events |  | 4th weeks | 
| Number of Participants With Adverse Events |  | 8th weeks |