N/A
Completed N=75
Effects of HX106 on Improvement in Cognitive-Bio-Markers of Memory Function
Healthy Adults With Subjective Memory Complaints
Source: ClinicalTrials.gov NCT01956097 ↗
Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcomePrimary: Changes From Baseline in Working Memory Domain Z-score — -0.21955; -0.15432; -0.08842; 0.29594 z-score
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes From Baseline in Working Memory Domain Z-score |
-0.21955; -0.15432; -0.08842; 0.29594; 0.34061; -0.27524 | — |
| PRIMARY Changes From Baseline in White Matter Integrity Assessment |
— | — |
| SECONDARY Number of Participants With Adverse Events |
12; 10; 8 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01956097). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.