Trial Outcomes & Findings for Effects of HX106 on Improvement in Cognitive-Bio-Markers of Memory Function (NCT NCT01956097)
NCT ID: NCT01956097
Last Updated: 2025-08-22
Results Overview
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.
COMPLETED
NA
75 participants
Baseline, 8th week
2025-08-22
Participant Flow
Participant milestones
| Measure |
HX106 590mg
HX106 590mg/day
HX106 590mg
|
HX106 1180mg
HX106 1180mg/day
HX106 1180mg
|
Placebo
Placebo
Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
15
|
|
Overall Study
COMPLETED
|
24
|
28
|
15
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of HX106 on Improvement in Cognitive-Bio-Markers of Memory Function
Baseline characteristics by cohort
| Measure |
HX106 590mg
n=30 Participants
HX106 590mg/day
HX106 590mg
|
HX106 1180mg
n=30 Participants
HX106 1180mg/day
HX106 1180mg
|
Placebo
n=15 Participants
Placebo
Placebo
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
75 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
37.6 years
STANDARD_DEVIATION 11.7 • n=99 Participants
|
42.5 years
STANDARD_DEVIATION 11.2 • n=107 Participants
|
40.6 years
STANDARD_DEVIATION 12.7 • n=206 Participants
|
40.1 years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
39 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
36 Participants
n=7 Participants
|
|
Region of Enrollment
Korea, Republic of
|
30 participants
n=99 Participants
|
30 participants
n=107 Participants
|
15 participants
n=206 Participants
|
75 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline, 8th weekTo 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.
Outcome measures
| Measure |
HX106 590mg
n=30 Participants
HX106 590mg/day
HX106 590mg
|
HX106 1180mg
n=30 Participants
HX106 1180mg/day
HX106 1180mg
|
Placebo
n=15 Participants
Placebo
Placebo
|
|---|---|---|---|
|
Changes From Baseline in Working Memory Domain Z-score
week8
|
0.29594 z-score
Standard Error 0.16938
|
0.34061 z-score
Standard Error 0.13436
|
-0.27524 z-score
Standard Error 0.13489
|
|
Changes From Baseline in Working Memory Domain Z-score
baseline
|
-0.21955 z-score
Standard Error 0.04450
|
-0.15432 z-score
Standard Error 0.03883
|
-0.08842 z-score
Standard Error 0.06861
|
PRIMARY outcome
Timeframe: Baseline, 8th weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1st weekPopulation: 2 participants in the "HX106 590mg" group and 1 participant in the "HX106 1180mg" were dropped out.
Outcome measures
| Measure |
HX106 590mg
n=28 Participants
HX106 590mg/day
HX106 590mg
|
HX106 1180mg
n=29 Participants
HX106 1180mg/day
HX106 1180mg
|
Placebo
n=15 Participants
Placebo
Placebo
|
|---|---|---|---|
|
Number of Participants With Adverse Events
|
17 number of participants
|
13 number of participants
|
0 number of participants
|
SECONDARY outcome
Timeframe: 4th weeksPopulation: 3 participants in the "HX106 590mg" group and 1 participant in the "HX106 1180mg" were dropped out.
Outcome measures
| Measure |
HX106 590mg
n=27 Participants
HX106 590mg/day
HX106 590mg
|
HX106 1180mg
n=29 Participants
HX106 1180mg/day
HX106 1180mg
|
Placebo
n=15 Participants
Placebo
Placebo
|
|---|---|---|---|
|
Number of Participants With Adverse Events
|
16 number of participants
|
18 number of participants
|
7 number of participants
|
SECONDARY outcome
Timeframe: 8th weeksPopulation: 6 participants in the "HX106 590mg" group and 2 participant in the "HX106 1180mg" were dropped out.
Outcome measures
| Measure |
HX106 590mg
n=24 Participants
HX106 590mg/day
HX106 590mg
|
HX106 1180mg
n=28 Participants
HX106 1180mg/day
HX106 1180mg
|
Placebo
n=15 Participants
Placebo
Placebo
|
|---|---|---|---|
|
Number of Participants With Adverse Events
|
12 number of participants
|
10 number of participants
|
8 number of participants
|
Adverse Events
HX106 590mg
HX106 1180mg
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
HX106 590mg
n=30 participants at risk
HX106 590mg/day
HX106 590mg
|
HX106 1180mg
n=30 participants at risk
HX106 1180mg/day
HX106 1180mg
|
Placebo
n=15 participants at risk
Placebo
Placebo
|
|---|---|---|---|
|
Cardiac disorders
Autonomic symptoms: palpitations/tachycardia
|
10.0%
3/30
|
6.7%
2/30
|
6.7%
1/15
|
|
Eye disorders
Autonomic symptoms: accomodation disturbances
|
10.0%
3/30
|
0.00%
0/30
|
13.3%
2/15
|
|
Gastrointestinal disorders
Autonomic symptoms: diarrhea
|
3.3%
1/30
|
0.00%
0/30
|
13.3%
2/15
|
|
Gastrointestinal disorders
Autonomic symptoms: constipation
|
13.3%
4/30
|
6.7%
2/30
|
0.00%
0/15
|
|
Gastrointestinal disorders
Autonomic symptoms: nausea/vomitting
|
6.7%
2/30
|
6.7%
2/30
|
13.3%
2/15
|
|
General disorders
Other symptoms: weight gain
|
20.0%
6/30
|
10.0%
3/30
|
0.00%
0/15
|
|
General disorders
Other symptoms: weight loss
|
13.3%
4/30
|
0.00%
0/30
|
13.3%
2/15
|
|
General disorders
Other symptoms: headache
|
20.0%
6/30
|
20.0%
6/30
|
33.3%
5/15
|
|
General disorders
Autonomic symptoms: orthostatic dizziness
|
16.7%
5/30
|
6.7%
2/30
|
13.3%
2/15
|
|
General disorders
Autonomic symptoms: increased tendency to sweating
|
6.7%
2/30
|
3.3%
1/30
|
13.3%
2/15
|
|
General disorders
Autonomic symptoms: reduced salivation
|
0.00%
0/30
|
3.3%
1/30
|
6.7%
1/15
|
|
Nervous system disorders
Neurologic symptoms: dystonia
|
0.00%
0/30
|
3.3%
1/30
|
13.3%
2/15
|
|
Nervous system disorders
Neurologic symptoms: rigidity
|
6.7%
2/30
|
6.7%
2/30
|
13.3%
2/15
|
|
Nervous system disorders
Neurologic symptoms: paresthesia
|
10.0%
3/30
|
0.00%
0/30
|
13.3%
2/15
|
|
Psychiatric disorders
Psychic symptoms: increased fatigability
|
36.7%
11/30
|
16.7%
5/30
|
26.7%
4/15
|
|
Psychiatric disorders
Psychic symptoms: sleepiness/sedation
|
30.0%
9/30
|
10.0%
3/30
|
13.3%
2/15
|
|
Psychiatric disorders
Psychic symptoms: failing memory
|
10.0%
3/30
|
3.3%
1/30
|
6.7%
1/15
|
|
Psychiatric disorders
Psychic symptoms: depression
|
13.3%
4/30
|
3.3%
1/30
|
20.0%
3/15
|
|
Psychiatric disorders
Psychic symptoms: tension/inner unrest
|
0.00%
0/30
|
3.3%
1/30
|
13.3%
2/15
|
|
Psychiatric disorders
Psychic symptoms: increased duration of sleep
|
6.7%
2/30
|
6.7%
2/30
|
6.7%
1/15
|
|
Psychiatric disorders
Psychic symptoms: reduced duration of sleep
|
23.3%
7/30
|
6.7%
2/30
|
6.7%
1/15
|
|
Psychiatric disorders
Psychic symptoms: increased dream activity
|
16.7%
5/30
|
6.7%
2/30
|
6.7%
1/15
|
|
Renal and urinary disorders
Autonomic symptoms: micturition disturbances
|
0.00%
0/30
|
0.00%
0/30
|
6.7%
1/15
|
|
Renal and urinary disorders
Autonomic symptoms: polyuria/polydipsia
|
3.3%
1/30
|
13.3%
4/30
|
6.7%
1/15
|
|
Reproductive system and breast disorders
Other symptoms: increased sexual desire
|
0.00%
0/30
|
0.00%
0/30
|
6.7%
1/15
|
|
Skin and subcutaneous tissue disorders
Other symptoms: rash
|
0.00%
0/30
|
10.0%
3/30
|
13.3%
2/15
|
|
Skin and subcutaneous tissue disorders
Other symptoms: morbilliform
|
0.00%
0/30
|
6.7%
2/30
|
6.7%
1/15
|
|
Skin and subcutaneous tissue disorders
Other symptoms: cannot be classified
|
0.00%
0/30
|
0.00%
0/30
|
6.7%
1/15
|
|
Skin and subcutaneous tissue disorders
Other symptoms: pruritus
|
13.3%
4/30
|
23.3%
7/30
|
13.3%
2/15
|
Additional Information
Soonhyun Ban, RN, MS
Ewha Brain Institute, Ewha W. University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place