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

Not Applicable

Completed

• Conditions: Healthy Adults With Subjective Memory Complaints
• Interventions: Dietary Supplement: HX106 1180mg; Dietary Supplement: HX106 590mg; Dietary Supplement: Placebo

• Registration Number: NCT01956097
• Lead Sponsor: Ewha Womans University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Study First Submitted: 2013-09-26
• Study First Submitted QC: 2013-10-01
• Study First Posted: 2013-10-08
• Results First Submitted: 2015-04-09
• Status Verified: 2015-05
• Results First Submitted QC: 2015-05-25
• Last Update Submitted: 2015-05-25
• Results First Posted: 2015-06-09
• Last Update Posted: 2015-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HX106 1180mg	HX106 1180mg	HX106 1180mg/day
HX106 590mg	HX106 590mg	HX106 590mg/day
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Changes From Baseline in Working Memory Domain Z-score	Baseline, 8th week	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.
Changes From Baseline in White Matter Integrity Assessment	Baseline, 8th weeks

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	8th weeks

Trial Locations

Locations (1)

Ewha W. University; 🇰🇷 Seoul, Korea, Republic of