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

NCT01956097 | Completed Results DMC

• 1 other identifier: HX106
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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 cognitive and neurobiolgoical markers of memory.

Conditions

Healthy Adults With Subjective Memory Complaints

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Number of Participants With Adverse Events

  1st week

• Number of Participants With Adverse Events

  4th weeks

• Number of Participants With Adverse Events

  8th weeks

Study Arms (3)

HX106 590mg

EXPERIMENTAL

HX106 590mg/day

Dietary Supplement: HX106 590mg

HX106 1180mg

EXPERIMENTAL

HX106 1180mg/day

Dietary Supplement: HX106 1180mg

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

HX106 590mg DIETARY_SUPPLEMENT

HX106 590mg

HX106 1180mg DIETARY_SUPPLEMENT

HX106 1180mg

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ewha Womans University: lead

Study Sites (1)

Ewha W. University

Seoul, 120-750, South Korea

Location

Results Point of Contact

• Title: Soonhyun Ban, RN, MS
• Organization: Ewha Brain Institute, Ewha W. University

soonhyun.s.ban@gmail.com

+82-2-3277-6550

Study Officials

• In Kyoon Lyoo, MD, PhD, MMS

  Ewha W. University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 26, 2013
• First Posted: October 8, 2013
• Study Start: March 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: August 22, 2025
• Results First Posted: June 9, 2015

Record last verified: 2025-08

Locations

KR (1)