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NCT Number: NCT01956097

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

The objectives of the current study are to evaluate the efficacy and safety of HX106 in healthy adults with subjective memory complaints for improving cognitive and neurobiolgoical markers of memory.

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Key information

Conditions

Healthy Adults With Subjective Memory Complaints

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ewha W. University

Seoul, 120-750, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HX106 590mg

Dietary Supplement

HX106 1180mg

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  1. Changes From Baseline in Working Memory Domain Z-score

    Time frame: 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.

  2. Changes From Baseline in White Matter Integrity Assessment

    Time frame: Baseline, 8th weeks

Secondary outcomes

  1. Number of Participants With Adverse Events

    Time frame: 1st week

  2. Number of Participants With Adverse Events

    Time frame: 4th weeks

  3. Number of Participants With Adverse Events

    Time frame: 8th weeks

Sponsors and collaborators

Lead sponsor

Ewha Womans University

Other

Registry information

Official study title

Effects of HX106 on Improvement in Cognitive-Bio-Markers of Memory Function in Healthy Adults With Subjective Memory Complaints

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 8, 2013
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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