NCT02379481

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2014

Completed
11 months until next milestone

First Posted

Study publicly available on registry

March 5, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

July 1, 2015

Status Verified

June 1, 2015

Enrollment Period

1.9 years

First QC Date

March 27, 2014

Last Update Submit

June 30, 2015

Conditions

Healthy Adults With Subjective Memory Complaints

Outcome Measures

Primary Outcomes (4)

  • Changes from baseline in neurocognitive function

    Scores from neurocognitive test batteries such as CANTAB

    Baseline, 8th week

  • Changes from baseline in brain structure analyzed using the computational approach

    Morphometric analysis of brain structures in magnetic resonance imaging

    Baseline, 8th week

  • Changes from baseline in brain function analyzed using the computational approach

    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

    Brain metabolite concentrations assessed using magnetic resonance spectroscopy

    Baseline, 8th week

Secondary Outcomes (4)

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

    Baseline, 8th week

  • Number of participants with adverse events

    1st week

  • Number of participants with adverse events

    4th week

  • Number of participants with adverse events

    8th week

Study Arms (3)

NS 550mg

EXPERIMENTAL

NS 550mg/day

Dietary Supplement: NS 550mg

NS 1100mg

EXPERIMENTAL

NS 1100mg/day

Dietary Supplement: NS 1100mg

placebo

PLACEBO COMPARATOR

placebo

Dietary Supplement: placebo

Interventions

NS 550mgDIETARY_SUPPLEMENT
NS 550mg
NS 1100mgDIETARY_SUPPLEMENT
NS 1100mg
placeboDIETARY_SUPPLEMENT
placebo

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 40 and 65 years old,
  • Global Deterioration Scale score (GDS) of 2
  • High school or higher levels of education.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ewha Womans University

Seoul, 120-750, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 27109158DERIVED

Study Officials

  • In Kyoon Lyoo, MD, PhD, MMS

    Ewha Womans University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 27, 2014

First Posted

March 5, 2015

Study Start

July 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

July 1, 2015

Record last verified: 2015-06

Locations

KR(1)