Healthy Adults With Subjective Memory ComplaintsNCT01956097
Effects of HX106 on Improvement in Cognitive-Bio-Markers of Memory Function
A study testing HX106 590mg and HX106 1180mg in people with Healthy Adults With Subjective Memory Complaints, run by Ewha Womans University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults With Subjective Memory Complaints
- What is being tested?
- HX106 590mg and HX106 1180mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2012to Jan 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of HX106 on Improvement in Cognitive-Bio-Markers of Memory Function in Healthy Adults With Subjective Memory Complaints
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.
Read the detailed description
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.
- Being tested
- HX106 590mg, HX106 1180mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HX106 590mgDietary supplement
HX106 1180mgDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| HX106 590mg | Experimental | HX106 590mg/day Receives: Dietary Supplement: HX106 590mg |
| HX106 1180mg | Experimental | HX106 1180mg/day Receives: Dietary Supplement: HX106 1180mg |
| Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 8th week
Changes From Baseline in White Matter Integrity Assessment
Measured: Baseline, 8th weeks
Secondary outcomes (3)
Number of Participants With Adverse Events
Measured: 1st week
Number of Participants With Adverse Events
Measured: 4th weeks
Number of Participants With Adverse Events
Measured: 8th weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startMar 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy Adults With Subjective Memory ComplaintsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ewha Womans University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In Kyoon Lyoo, Ewha Womans University
- Investigators
- In Kyoon Lyoo, MD, PhD, MMS, Principal investigator, Ewha W. University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01956097
- Sponsor's protocol ID
- HX106
- Status last verified
- Aug 2025
- First submitted
- 26 Sep 2013
- Last updated
- 22 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of HX106 on Improvement in Cognitive-Bio-Markers of Memory Function in Healthy Adults With Subjective Memory Complaints
- ClinicalTrials.gov ID
- NCT01956097
- Acronym / sponsor ID
- HX106
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Ewha Womans UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Posted 9 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HX106 590mg | Experimental | Dietary Supplement: HX106 590mgHX106 590mg/day |
| HX106 1180mg | Experimental | Dietary Supplement: HX106 1180mgHX106 1180mg/day |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HX106 590mg | Dietary supplement | HX106 590mg |
| HX106 1180mg | Dietary supplement | HX106 1180mg |
| Placebo | Dietary supplement | Placebo |
Primary outcome
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
3 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
In Kyoon Lyoo, MD, PhD, MMS principal investigator
Ewha W. University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HX106 590mg and HX106 1180mg in people with Healthy Adults With Subjective Memory Complaints, run by Ewha Womans University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes From Baseline in Working Memory Domain Z-score (time frame: Baseline, 8th week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.