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

N/ACompletedNCT01956097

Ewha Womans University75 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Healthy Adults With Subjective Memory Complaints

Interventions

HX106 590mgDIETARY_SUPPLEMENT

HX106 1180mgDIETARY_SUPPLEMENT

PlaceboDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 20 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Ewha W. University

Seoul, South Korea

Outcomes

Primary Outcomes

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.

Time frame: Baseline, 8th week

Changes From Baseline in White Matter Integrity Assessment

Time frame: Baseline, 8th weeks

Secondary Outcomes

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

Data from ClinicalTrials.gov

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