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

June 30, 2015 updated by: In Kyoon Lyoo, Ewha Womans University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Dietary supplement: placebo
Experimental: NS 550mg
NS 550mg/day
Dietary supplement: NS 550mg
Experimental: NS 1100mg
NS 1100mg/day
Dietary supplement: NS 1100mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline in neurocognitive function
Time Frame: Baseline, 8th week
Scores from neurocognitive test batteries such as CANTAB
Baseline, 8th week
Changes from baseline in brain structure analyzed using the computational approach
Time Frame: Baseline, 8th week
Morphometric analysis of brain structures in magnetic resonance imaging
Baseline, 8th week
Changes from baseline in brain function analyzed using the computational approach
Time Frame: Baseline, 8th week
Blood oxygenation level dependent (BOLD) signal intensity and their connectivity assessed using functional magnetic resonance imaging scans
Baseline, 8th week
Changes from baseline in brain biochemical metabolism analyzed using the computational approach
Time Frame: Baseline, 8th week
Brain metabolite concentrations assessed using magnetic resonance spectroscopy
Baseline, 8th week

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events
Time Frame: 1st week
1st week
Number of participants with adverse events
Time Frame: 4th week
4th week
Number of participants with adverse events
Time Frame: 8th week
8th week
Change from baseline in Subjective Memory Complaints Questionnaire scores at 8th weeks
Time Frame: Baseline, 8th week
Baseline, 8th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ewha Womans University

Investigators

  • Principal Investigator: In Kyoon Lyoo, MD, PhD, MMS, Ewha Womans University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

March 27, 2014

First Submitted That Met QC Criteria

March 4, 2015

First Posted (Estimate)

March 5, 2015

Study Record Updates

Last Update Posted (Estimate)

July 1, 2015

Last Update Submitted That Met QC Criteria

June 30, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • CT_NS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

3
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