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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
In Kyoon Lyoo, Ewha Womans University
ClinicalTrials.gov Identifier:
NCT01956097
First received: September 26, 2013
Last updated: May 25, 2015
Last verified: May 2015
September 26, 2013
May 25, 2015
March 2012
January 2013   (Final data collection date for primary outcome measure)
  • 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.

  • Changes From Baseline in White Matter Integrity Assessment [ Time Frame: Baseline, 8th weeks ]
  • Changes from baseline in neurocognitive function [ Time Frame: Baseline, 8th weeks ]
  • Changes from baseline in brain structure analyzed using the computational approach [ Time Frame: Baseline, 8th week ]
    Morphometric analysis of brain structures in magnetic resonance imaging
  • Changes from baseline in brain function analyzed using the computational approach [ Time Frame: Baseline, 8th weeks ]
    Blood oxygenation level dependent (BOLD) signal intensity and their connectivity assessed using functional magnetic resonance imaging scans
  • Changes from baseline in brain biochemical metabolism analyzed using the computational approach [ Time Frame: Baseline, 8th weeks ]
    Brain metabolite concentrations assessed using magnetic resonance spectroscopy
Complete list of historical versions of study NCT01956097 on ClinicalTrials.gov Archive Site
  • Number of Participants With Adverse Events [ Time Frame: 1st week ]
  • Number of Participants With Adverse Events [ Time Frame: 4th weeks ]
  • Number of Participants With Adverse Events [ Time Frame: 8th weeks ]
  • Change from baseline in Subjective Memory Complaints Questionnaire scores at 8th weeks [ Time Frame: Baseline, 8th weeks ]
  • Number of Participants With Adverse Events [ Time Frame: 1st week ]
  • Number of Participants With Adverse Events [ Time Frame: 4th weeks ]
  • Number of Participants With Adverse Events [ Time Frame: 8th weeks ]
Not Provided
Not Provided
 
Effects of HX106 on Improvement in Cognitive-Bio-Markers of Memory Function
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
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Healthy Adults With Subjective Memory Complaints
  • Dietary Supplement: HX106 590mg
  • Dietary Supplement: HX106 1180mg
  • Dietary Supplement: Placebo
  • Experimental: HX106 590mg
    HX106 590mg/day
    Intervention: Dietary Supplement: HX106 590mg
  • Experimental: HX106 1180mg
    HX106 1180mg/day
    Intervention: Dietary Supplement: HX106 1180mg
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
January 2013
January 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years to 60 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01956097
HX106
Yes
Not Provided
Not Provided
In Kyoon Lyoo, Ewha Womans University
Ewha Womans University
Not Provided
Principal Investigator: In Kyoon Lyoo, MD, PhD, MMS Ewha W. University
Ewha Womans University
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP