Clinical trial NCT02379481: Effects of Deer Bone Extract NS on Improvement in Cognitive-Bio-Markers of Cognitive Functions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Adults With Subjective Memory Complaints
Lead sponsor: Ewha Womans University
Sponsor class: OTHER
First posted: 2015-03-05
Enrollment: 75
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to elucidate the effects of deer bone extract NS on cognitive function improvement and its safety in healthy adults aged 40 to 65 years who report decline in subjective cognitive functions using multimodal neuroimaging and neurocognitive assessments.


Eligibility criteria: Inclusion Criteria:

* Age between 40 and 65 years old,
* Global Deterioration Scale score (GDS) of 2
* 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 70
* 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.

Primary outcomes:
measure: Changes from baseline in neurocognitive function
timeFrame: Baseline, 8th week
measure: Changes from baseline in brain structure analyzed using the computational approach
timeFrame: Baseline, 8th week
measure: Changes from baseline in brain function analyzed using the computational approach
timeFrame: Baseline, 8th week
measure: Changes from baseline in brain biochemical metabolism analyzed using the computational approach
timeFrame: Baseline, 8th week
Secondary outcomes:
measure: Change from baseline in Subjective Memory Complaints Questionnaire scores at 8th weeks
timeFrame: Baseline, 8th week
measure: Number of participants with adverse events
timeFrame: 1st week
measure: Number of participants with adverse events
timeFrame: 4th week
measure: Number of participants with adverse events
timeFrame: 8th week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University
Study officials:
affiliation: Ewha Womans University
name: In Kyoon Lyoo, MD, PhD, MMS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jeon Y, Kim B, Kim JE, Kim BR, Ban S, Jeong JH, Kwon O, Rhie SJ, Ahn CW, Kim JH, Jung SU, Park SH, Lyoo IK, Yoon S. Effects of Ganglioside on Working Memory and the Default Mode Network in Individuals with Subjective Cognitive Impairment: A Randomized Controlled Trial. Am J Chin Med. 2016;44(3):489-514. doi: 10.1142/S0192415X16500270. Epub 2016 Apr 24.