Effects of HX106 on Improvement in Cognitive-Bio-Markers of Memory Function

Ewha Womans University

Status: Completed

Conditions: Healthy Adults With Subjective Memory Complaints

Treatments: Dietary Supplement: Placebo; Dietary Supplement: HX106 590mg; Dietary Supplement: HX106 1180mg

Study type: Interventional

Funder types: Other

Identifiers

NCT01956097

HX106

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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75 participants in 3 patient groups, including a placebo group

HX106 590mg

Experimental group

Description:

HX106 590mg/day

Treatment:

Dietary Supplement: HX106 590mg

HX106 1180mg

Experimental group

Description:

HX106 1180mg/day

Treatment:

Dietary Supplement: HX106 1180mg

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Dietary Supplement: Placebo