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OpenTrials
Completed

NCT Number: NCT02379481

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

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.

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Key information

Conditions

Healthy Adults With Subjective Memory Complaints

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ewha Womans University

Seoul, 120-750, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NS 550mg

Dietary Supplement

NS 1100mg

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  1. Changes from baseline in neurocognitive function

    Time frame: Baseline, 8th week

    Scores from neurocognitive test batteries such as CANTAB

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. Change from baseline in Subjective Memory Complaints Questionnaire scores at 8th weeks

    Time frame: Baseline, 8th week

  2. Number of participants with adverse events

    Time frame: 1st week

  3. Number of participants with adverse events

    Time frame: 4th week

  4. Number of participants with adverse events

    Time frame: 8th week

Sponsors and collaborators

Lead sponsor

Ewha Womans University

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 5, 2015
Registry last updated
Jul 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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