Effects of Tremella Fuciformis on Improvement in Cognitive-Bio-Markers of Cognitive Functions

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Tremella Fuciformis on Improvement in Cognitive-Bio-Markers of Cognitive Functions in Healthy Adults With Subjective Cognitive Impairment: An 8-Week Prospective Randomized Double-Blind Placebo-Controlled Trial With Multimodal Neuroimaging and Neurocognitive Assessments

Conditions
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Healthy Adults With Subjective Memory Complaints

Intervention / Treatment
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* Dietary Supplement: TF 600mg
* Dietary Supplement: TF 1200mg
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TF 600mg<br>TF 600mg/day | Dietary Supplement: TF 600mg<br> <br> |
| Experimental: TF 1200mg<br>TF 1200mg/day | Dietary Supplement: TF 1200mg<br> <br> |
| Placebo Comparator: placebo<br>placebo | Dietary Supplement: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in neurocognitive function (neurocognitive test batteries such as CANTAB) | 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) | Blood oxygenation level dependent (BOLD) signal intensity and their connectivity assessed using functional magnetic resonance imaging scans | baseline, 8 week | 
| Changes from baseline in brain biochemical metabolism analyzed using the computational approach (Brain metabolite concentrations assessed using magnetic resonance spectroscopy) | Brain metabolite concentrations assessed using magnetic resonance spectroscopy | baseline, 8th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 
| Number of participants with adverse events |  | 8th week |