Healthy Adults With Subjective Memory Complaints
Conditions
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.
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.
Interventions
DIETARY_SUPPLEMENTHX106 590mg
DIETARY_SUPPLEMENTHX106 1180mg
DIETARY_SUPPLEMENTPlacebo
Sponsors
Ewha Womans University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes From Baseline in Working Memory Domain Z-score | 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 | Baseline, 8th weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events | 1st week |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HX106 590mg HX106 590mg/day
HX106 590mg | 30 |
| HX106 1180mg HX106 1180mg/day
HX106 1180mg | 30 |
| Placebo Placebo
Placebo | 15 |
| Total | 75 |
Baseline characteristics
| Characteristic | HX106 1180mg | Placebo | HX106 590mg | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 15 Participants | 30 Participants | 75 Participants |
| Age, Continuous | 42.5 years STANDARD_DEVIATION 11.2 | 40.6 years STANDARD_DEVIATION 12.7 | 37.6 years STANDARD_DEVIATION 11.7 | 40.1 years STANDARD_DEVIATION 11.7 |
| Region of Enrollment Korea, Republic of | 30 participants | 15 participants | 30 participants | 75 participants |
| Sex: Female, Male Female | 17 Participants | 4 Participants | 18 Participants | 39 Participants |
| Sex: Female, Male Male | 13 Participants | 11 Participants | 12 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 23 / 30 | 22 / 30 | 12 / 15 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 15 |
Outcome results
Primary
Changes From Baseline in White Matter Integrity Assessment
Time frame: Baseline, 8th weeks
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.
Time frame: Baseline, 8th week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HX106 590mg | Changes From Baseline in Working Memory Domain Z-score | baseline | -0.21955 z-score | Standard Error 0.0445 |
| HX106 590mg | Changes From Baseline in Working Memory Domain Z-score | week8 | 0.29594 z-score | Standard Error 0.16938 |
| HX106 1180mg | Changes From Baseline in Working Memory Domain Z-score | baseline | -0.15432 z-score | Standard Error 0.03883 |
| HX106 1180mg | Changes From Baseline in Working Memory Domain Z-score | week8 | 0.34061 z-score | Standard Error 0.13436 |
| Placebo | Changes From Baseline in Working Memory Domain Z-score | baseline | -0.08842 z-score | Standard Error 0.06861 |
| Placebo | Changes From Baseline in Working Memory Domain Z-score | week8 | -0.27524 z-score | Standard Error 0.13489 |
Secondary
Number of Participants With Adverse Events
Time frame: 1st week
Population: 2 participants in the HX106 590mg group and 1 participant in the HX106 1180mg were dropped out.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HX106 590mg | Number of Participants With Adverse Events | 17 number of participants |
| HX106 1180mg | Number of Participants With Adverse Events | 13 number of participants |
| Placebo | Number of Participants With Adverse Events | 0 number of participants |
Secondary
Number of Participants With Adverse Events
Time frame: 4th weeks
Population: 3 participants in the HX106 590mg group and 1 participant in the HX106 1180mg were dropped out.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HX106 590mg | Number of Participants With Adverse Events | 16 number of participants |
| HX106 1180mg | Number of Participants With Adverse Events | 18 number of participants |
| Placebo | Number of Participants With Adverse Events | 7 number of participants |
Secondary
Number of Participants With Adverse Events
Time frame: 8th weeks
Population: 6 participants in the HX106 590mg group and 2 participant in the HX106 1180mg were dropped out.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HX106 590mg | Number of Participants With Adverse Events | 12 number of participants |
| HX106 1180mg | Number of Participants With Adverse Events | 10 number of participants |
| Placebo | Number of Participants With Adverse Events | 8 number of participants |