Healthy Adults With Subjective Memory Complaints
Conditions
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.
Interventions
DIETARY_SUPPLEMENTNS 550mg
DIETARY_SUPPLEMENTNS 1100mg
DIETARY_SUPPLEMENTplacebo
Sponsors
Ewha Womans University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline in neurocognitive function | Baseline, 8th week | Scores from neurocognitive test batteries such as CANTAB |
| Changes from baseline in brain structure analyzed using the computational approach | Baseline, 8th week | Morphometric analysis of brain structures in magnetic resonance imaging |
| Changes from baseline in brain function analyzed using the computational approach | 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 | Baseline, 8th week | Brain metabolite concentrations assessed using magnetic resonance spectroscopy |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Subjective Memory Complaints Questionnaire scores at 8th weeks | Baseline, 8th week |
| Number of participants with adverse events | 1st week |
Countries
South Korea
Outcome results
None listed