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Completed

NCT Number: NCT02377024

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

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.

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Key information

Conditions

Healthy Adults With Subjective Memory Complaints

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ewha Womans University

Seoul, 120-750, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TF 600mg

Dietary Supplement

TF 1200mg

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  1. Changes from baseline in neurocognitive function (neurocognitive test batteries such as CANTAB)

    Time frame: baseline, 8th week

    Scores from neurocognitive test batteries such as CANTAB

  2. 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

  3. Changes from baseline in brain function analyzed using the computational approach (Blood oxygenation level dependent (BOLD) signal intensity)

    Time frame: baseline, 8 week

    Blood oxygenation level dependent (BOLD) signal intensity and their connectivity assessed using functional magnetic resonance imaging scans

  4. Changes from baseline in brain biochemical metabolism analyzed using the computational approach (Brain metabolite concentrations assessed using magnetic resonance spectroscopy)

    Time frame: baseline, 8th week

    Brain metabolite concentrations assessed using magnetic resonance spectroscopy

Secondary outcomes

  1. Change from baseline in Subjective Memory Complaints Questionnaire scores at 8th weeks

    Time frame: baseline, 8th week

  2. Number of participants with adverse events

    Time frame: 4th week

  3. Number of participants with adverse events

    Time frame: 8th week

Sponsors and collaborators

Lead sponsor

Ewha Womans University

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 3, 2015
Registry last updated
Jul 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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