Effects of Deer Bone Extract NS on Improvement in Cognitive-Bio-Markers of Cognitive Functions

NCT ID: NCT02379481

Last Updated: 2015-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2015-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Adults With Subjective Memory Complaints

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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NS 550mg

NS 550mg/day

Group Type EXPERIMENTAL

NS 550mg

Intervention Type DIETARY_SUPPLEMENT

NS 1100mg

NS 1100mg/day

Group Type EXPERIMENTAL

NS 1100mg

Intervention Type DIETARY_SUPPLEMENT

placebo

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

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NS 550mg

Intervention Type DIETARY_SUPPLEMENT

NS 1100mg

Intervention Type DIETARY_SUPPLEMENT

placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ewha Womans University

OTHER

Sponsor Role lead

Responsible Party

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In Kyoon Lyoo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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In Kyoon Lyoo, MD, PhD, MMS

Role: PRINCIPAL_INVESTIGATOR

Ewha Womans University

Locations

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Ewha Womans University

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 27109158 (View on PubMed)

Other Identifiers

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CT_NS

Identifier Type: -

Identifier Source: org_study_id

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