Healthy Adults With Subjective Memory ComplaintsNCT02379481
Effects of Deer Bone Extract NS on Improvement in Cognitive-Bio-Markers of Cognitive Functions
A study testing NS 550mg and NS 1100mg in people with Healthy Adults With Subjective Memory Complaints, run by Ewha Womans University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults With Subjective Memory Complaints
- What is being tested?
- NS 550mg and NS 1100mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2013to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 40 and 65 years old,
- Global Deterioration Scale score (GDS) of 2
- High school or higher levels of education.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- NS 550mg, NS 1100mg, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NS 550mgDietary supplement
NS 1100mgDietary supplement
placeboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| NS 550mg | Experimental | NS 550mg/day Receives: Dietary Supplement: NS 550mg |
| NS 1100mg | Experimental | NS 1100mg/day Receives: Dietary Supplement: NS 1100mg |
| placebo | Placebo comparator | placebo Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in neurocognitive function
Scores from neurocognitive test batteries such as CANTAB
Measured: Baseline, 8th week
Changes from baseline in brain structure analyzed using the computational approach
Morphometric analysis of brain structures in magnetic resonance imaging
Measured: 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
Measured: Baseline, 8th week
Changes from baseline in brain biochemical metabolism analyzed using the computational approach
Brain metabolite concentrations assessed using magnetic resonance spectroscopy
Measured: Baseline, 8th week
Secondary outcomes (4)
Change from baseline in Subjective Memory Complaints Questionnaire scores at 8th weeks
Measured: Baseline, 8th week
Number of participants with adverse events
Measured: 1st week
Number of participants with adverse events
Measured: 4th week
Number of participants with adverse events
Measured: 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startJul 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Adults With Subjective Memory ComplaintsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ewha Womans University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In Kyoon Lyoo, Ewha Womans University
- Investigators
- In Kyoon Lyoo, MD, PhD, MMS, Principal investigator, Ewha Womans University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02379481
- Sponsor's protocol ID
- CT_NS
- Status last verified
- Jun 2015
- First submitted
- 27 Mar 2014
- Last updated
- 1 Jul 2015
- Results posted
- No
Publications
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.
PubMed 27109158
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Deer Bone Extract NS on Improvement in Cognitive-Bio-Markers of Cognitive Functions
- ClinicalTrials.gov ID
- NCT02379481
- Acronym / sponsor ID
- CT_NS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Ewha Womans UniversityUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 5 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NS 550mg | Experimental | Dietary Supplement: NS 550mgNS 550mg/day |
| NS 1100mg | Experimental | Dietary Supplement: NS 1100mgNS 1100mg/day |
| placebo | Placebo comparator | Dietary Supplement: placeboplacebo |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 40 and 65 years old,
- Global Deterioration Scale score (GDS) of 2
- High school or higher levels of education.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NS 550mg | Dietary supplement | NS 550mg |
| NS 1100mg | Dietary supplement | NS 1100mg |
| placebo | Dietary supplement | placebo |
Primary outcome
Changes from baseline in neurocognitive function
Time frame: Baseline, 8th week
Scores from neurocognitive test batteries such as CANTAB
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
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
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
4 secondary outcomes
Change from baseline in Subjective Memory Complaints Questionnaire scores at 8th weeks
Time frame: Baseline, 8th week
Number of participants with adverse events
Time frame: 1st week
Number of participants with adverse events
Time frame: 4th week
Number of participants with adverse events
Time frame: 8th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2015.
- Derived from this study: PubMed 27109158Jeon 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
In Kyoon Lyoo, MD, PhD, MMS principal investigator
Ewha Womans University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NS 550mg and NS 1100mg in people with Healthy Adults With Subjective Memory Complaints, run by Ewha Womans University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in neurocognitive function (time frame: Baseline, 8th week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02379481, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2015.