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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Ewha Womans University
Sponsor:
Information provided by (Responsible Party):
In Kyoon Lyoo, Ewha Womans University
ClinicalTrials.gov Identifier:
NCT01956097
First received: September 26, 2013
Last updated: October 1, 2013
Last verified: October 2013
  Purpose

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 Intervention
Healthy Adults With Subjective Memory Complaints
Dietary Supplement: HX106 590mg
Dietary Supplement: HX106 1180mg
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Ewha Womans University:

Primary Outcome Measures:
  • Changes from baseline in neurocognitive function [ Time Frame: Baseline, 8th weeks ] [ Designated as safety issue: No ]
  • Changes from baseline in brain structure analyzed using the computational approach [ Time Frame: Baseline, 8th weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Brain metabolite concentrations assessed using magnetic resonance spectroscopy


Secondary Outcome Measures:
  • Change from baseline in Subjective Memory Complaints Questionnaire scores at 8th weeks [ Time Frame: Baseline, 8th weeks ] [ Designated as safety issue: No ]
  • Number of participants with adverse events [ Time Frame: 1st week ] [ Designated as safety issue: Yes ]
  • Number of participants with adverse events [ Time Frame: 4th weeks ] [ Designated as safety issue: Yes ]
  • Number of participants with adverse events [ Time Frame: 8th weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 75
Study Start Date: March 2012
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HX106 590mg
HX106 590mg/day
Dietary Supplement: HX106 590mg
Experimental: HX106 1180mg
HX106 1180mg/day
Dietary Supplement: HX106 1180mg
Placebo Comparator: Placebo
Placebo
Dietary Supplement: Placebo

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01956097

Contacts
Contact: Jieun E Kim, MD, PhD 82-2-3277-6932 kjieun@ewha.ac.kr

Locations
Korea, Republic of
Ewha W. University Recruiting
Seoul, Korea, Republic of, 120-750
Contact: Hyeonseok S Jeong, MS    82-2-3277-6929    alexhsjeong@gmail.com   
Principal Investigator: In Kyoon Lyoo, MD, PhD, MMS         
Sponsors and Collaborators
Ewha Womans University
Investigators
Principal Investigator: In Kyoon Lyoo, MD, PhD, MMS Ewha W. University
  More Information

No publications provided

Responsible Party: In Kyoon Lyoo, Professor, Ewha Womans University
ClinicalTrials.gov Identifier: NCT01956097     History of Changes
Other Study ID Numbers: HX106
Study First Received: September 26, 2013
Last Updated: October 1, 2013
Health Authority: Korea: Ministry of Food and Drug Safety

ClinicalTrials.gov processed this record on July 23, 2014