Healthy Adults With Subjective Memory Complaints
Conditions
Brief summary
The objective of this study is to demonstrate the cognitive enhancement effect and safety of Tremella Fuciformis, using the cognitive and clinical indicators (e.g. memory, attention, and psychomotor speed) and the latest brain imaging methods for healthy adults suffering subjective cognitive impairment.
Interventions
DIETARY_SUPPLEMENTTF 600mg
DIETARY_SUPPLEMENTTF 1200mg
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
No
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) * 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 * 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 * Allergic adverse reactions to mushrooms
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline in neurocognitive function (neurocognitive test batteries such as CANTAB) | 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 (Blood oxygenation level dependent (BOLD) signal intensity) | baseline, 8 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 (Brain metabolite concentrations assessed using magnetic resonance spectroscopy) | 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 | 4th week |
Countries
South Korea
Outcome results
None listed