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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HX106 590mg | Experimental | HX106 590mg/day |
|
| HX106 1180mg | Experimental | HX106 1180mg/day |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HX106 590mg | Dietary Supplement |
| ||
| HX106 1180mg |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | 1st week | |
| Number of Participants With Adverse Events | 4th weeks | |
| Number of Participants With Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| In Kyoon Lyoo, MD, PhD, MMS | Ewha W. University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ewha W. University | Seoul | 120-750 | South Korea |
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| ID | Title | Description |
|---|---|---|
| FG000 | HX106 590mg | HX106 590mg/day HX106 590mg |
| FG001 | HX106 1180mg | HX106 1180mg/day HX106 1180mg |
| FG002 | Placebo | Placebo Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HX106 590mg | HX106 590mg/day HX106 590mg |
| BG001 | HX106 1180mg | HX106 1180mg/day HX106 1180mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Error | z-score | Baseline, 8th week |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HX106 590mg | HX106 590mg/day HX106 590mg |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Autonomic symptoms: palpitations/tachycardia | Cardiac disorders | Systematic Assessment | any of the side effects listed in the UKU side effect rating scale |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Soonhyun Ban, RN, MS | Ewha Brain Institute, Ewha W. University | +82-2-3277-6550 | 6554 | soonhyun.s.ban@gmail.com |
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|
| Placebo | Dietary Supplement |
|
| 8th weeks |
| BG002 |
| Placebo |
Placebo Placebo |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
HX106 590mg/day
HX106 590mg
| OG001 | HX106 1180mg | HX106 1180mg/day HX106 1180mg |
| OG002 | Placebo | Placebo Placebo |
|
|
| Primary | Changes From Baseline in White Matter Integrity Assessment | Not Posted | Baseline, 8th weeks | Participants |
| Secondary | Number of Participants With Adverse Events | 2 participants in the "HX106 590mg" group and 1 participant in the "HX106 1180mg" were dropped out. | Posted | Number | number of participants | 1st week |
|
|
|
| Secondary | Number of Participants With Adverse Events | 3 participants in the "HX106 590mg" group and 1 participant in the "HX106 1180mg" were dropped out. | Posted | Number | number of participants | 4th weeks |
|
|
|
| Secondary | Number of Participants With Adverse Events | 6 participants in the "HX106 590mg" group and 2 participant in the "HX106 1180mg" were dropped out. | Posted | Number | number of participants | 8th weeks |
|
|
|
| 0 |
| 30 |
| 23 |
| 30 |
| EG001 | HX106 1180mg | HX106 1180mg/day HX106 1180mg | 0 | 30 | 22 | 30 |
| EG002 | Placebo | Placebo Placebo | 0 | 15 | 12 | 15 |
|
| Autonomic symptoms: accomodation disturbances | Eye disorders | Systematic Assessment | any of the side effects listed in the UKU side effect rating scale |
|
| Autonomic symptoms: diarrhea | Gastrointestinal disorders | Systematic Assessment | any of the side effects listed in the UKU side effect rating scale |
|
| Autonomic symptoms: constipation | Gastrointestinal disorders | Systematic Assessment | any of the side effects listed in the UKU side effect rating scale |
|
| Autonomic symptoms: nausea/vomitting | Gastrointestinal disorders | Systematic Assessment | any of the side effects listed in the UKU side effect rating scale |
|
| Other symptoms: weight gain | General disorders | Systematic Assessment | any of the side effects listed in the UKU side effect rating scale |
|
| Other symptoms: weight loss | General disorders | Systematic Assessment | any of the side effects listed in the UKU side effect rating scale |
|
| Other symptoms: headache | General disorders | Systematic Assessment | any of the side effects listed in the UKU side effect rating scale |
|
| Autonomic symptoms: orthostatic dizziness | General disorders | Systematic Assessment | any of the side effects listed in the UKU side effect rating scale |
|
| Autonomic symptoms: increased tendency to sweating | General disorders | Systematic Assessment | any of the side effects listed in the UKU side effect rating scale |
|
| Autonomic symptoms: reduced salivation | General disorders | Systematic Assessment | any of the side effects listed in the UKU side effect rating scale |
|
| Neurologic symptoms: dystonia | Nervous system disorders | Systematic Assessment | any of the side effects listed in the UKU side effect rating scale |
|
| Neurologic symptoms: rigidity | Nervous system disorders | Systematic Assessment | any of the side effects listed in the UKU side effect rating scale |
|
| Neurologic symptoms: paresthesia | Nervous system disorders | Systematic Assessment | any of the side effects listed in the UKU side effect rating scale |
|
| Psychic symptoms: increased fatigability | Psychiatric disorders | Systematic Assessment | any of the side effects listed in the UKU side effect rating scale |
|
| Psychic symptoms: sleepiness/sedation | Psychiatric disorders | Systematic Assessment | any of the side effects listed in the UKU side effect rating scale |
|
| Psychic symptoms: failing memory | Psychiatric disorders | Systematic Assessment | any of the side effects listed in the UKU side effect rating scale |
|
| Psychic symptoms: depression | Psychiatric disorders | Systematic Assessment | any of the side effects listed in the UKU side effect rating scale |
|
| Psychic symptoms: tension/inner unrest | Psychiatric disorders | Systematic Assessment | any of the side effects listed in the UKU side effect rating scale |
|
| Psychic symptoms: increased duration of sleep | Psychiatric disorders | Systematic Assessment | any of the side effects listed in the UKU side effect rating scale |
|
| Psychic symptoms: reduced duration of sleep | Psychiatric disorders | Systematic Assessment | any of the side effects listed in the UKU side effect rating scale |
|
| Psychic symptoms: increased dream activity | Psychiatric disorders | Systematic Assessment | any of the side effects listed in the UKU side effect rating scale |
|
| Autonomic symptoms: micturition disturbances | Renal and urinary disorders | Systematic Assessment | any of the side effects listed in the UKU side effect rating scale |
|
| Autonomic symptoms: polyuria/polydipsia | Renal and urinary disorders | Systematic Assessment | any of the side effects listed in the UKU side effect rating scale |
|
| Other symptoms: increased sexual desire | Reproductive system and breast disorders | Systematic Assessment | any of the side effects listed in the UKU side effect rating scale |
|
| Other symptoms: rash | Skin and subcutaneous tissue disorders | Systematic Assessment | any of the side effects listed in the UKU side effect rating scale |
|
| Other symptoms: morbilliform | Skin and subcutaneous tissue disorders | Systematic Assessment | any of the side effects listed in the UKU side effect rating scale |
|
| Other symptoms: cannot be classified | Skin and subcutaneous tissue disorders | Systematic Assessment | any of the side effects listed in the UKU side effect rating scale |
|
| Other symptoms: pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment | any of the side effects listed in the UKU side effect rating scale |
|
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