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.

Study Overview

• Status: Completed
• Conditions: Healthy Adults With Subjective Memory Complaints
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: HX106 590mg; Dietary supplement: HX106 1180mg

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-750
    • Ewha W. University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo
Experimental: HX106 590mg; HX106 590mg/day	Dietary supplement: HX106 590mg
Experimental: HX106 1180mg; HX106 1180mg/day	Dietary supplement: HX106 1180mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes From Baseline in Working Memory Domain Z-score	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.	Baseline, 8th week
Changes From Baseline in White Matter Integrity Assessment		Baseline, 8th weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Adverse Events	1st week
Number of Participants With Adverse Events	4th weeks
Number of Participants With Adverse Events	8th weeks

Collaborators and Investigators

• Sponsor: Ewha Womans University
• Investigators: Principal Investigator: In Kyoon Lyoo, MD, PhD, MMS, Ewha W. University

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: September 26, 2013
• First Submitted That Met QC Criteria: October 1, 2013
• First Posted (Estimate): October 8, 2013

Study Record Updates

• Last Update Posted (Estimate): June 9, 2015
• Last Update Submitted That Met QC Criteria: May 25, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: HX106