Clinical trial NCT02377024: Effects of Tremella Fuciformis on Improvement in Cognitive-Bio-Markers of Cognitive Functions
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Adults With Subjective Memory Complaints
Lead sponsor: Ewha Womans University
Sponsor class: OTHER
First posted: 2015-03-03
Enrollment: 75
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes from baseline in neurocognitive function (neurocognitive test batteries such as CANTAB)
timeFrame: baseline, 8th week
measure: Changes from baseline in brain structure analyzed using the computational approach
timeFrame: baseline, 8th week
measure: Changes from baseline in brain function analyzed using the computational approach (Blood oxygenation level dependent (BOLD) signal intensity)
timeFrame: baseline, 8 week
measure: Changes from baseline in brain biochemical metabolism analyzed using the computational approach (Brain metabolite concentrations assessed using magnetic resonance spectroscopy)
timeFrame: baseline, 8th week
Secondary outcomes:
measure: Change from baseline in Subjective Memory Complaints Questionnaire scores at 8th weeks
timeFrame: baseline, 8th week
measure: Number of participants with adverse events
timeFrame: 4th week
measure: Number of participants with adverse events
timeFrame: 8th week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University
Study officials:
References: