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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01956097
Recruitment Status : Completed
First Posted : October 8, 2013
Results First Posted : June 9, 2015
Last Update Posted : June 9, 2015
Information provided by (Responsible Party):
In Kyoon Lyoo, 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.

Condition or disease Intervention/treatment Phase
Healthy Adults With Subjective Memory Complaints Dietary Supplement: HX106 590mg Dietary Supplement: HX106 1180mg Dietary Supplement: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Experimental: HX106 590mg
HX106 590mg/day
Dietary Supplement: HX106 590mg
Experimental: HX106 1180mg
HX106 1180mg/day
Dietary Supplement: HX106 1180mg
Placebo Comparator: Placebo
Dietary Supplement: Placebo

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01956097

Korea, Republic of
Ewha W. University
Seoul, Korea, Republic of, 120-750
Sponsors and Collaborators
Ewha Womans University
Principal Investigator: In Kyoon Lyoo, MD, PhD, MMS Ewha W. University

Responsible Party: In Kyoon Lyoo, Professor, Ewha Womans University Identifier: NCT01956097     History of Changes
Other Study ID Numbers: HX106
First Posted: October 8, 2013    Key Record Dates
Results First Posted: June 9, 2015
Last Update Posted: June 9, 2015
Last Verified: May 2015