Effects of Fermented Codonopsis Lanceolata on Improvement in Cognitive-Bio-Markers of Cognitive Functions

Effects of Fermented Codonopsis Lanceolata on Improvement in Cognitive-Bio-Markers of Cognitive Functions in Healthy Adults With Subjective Memory Impairment: An 8-week Prospective Randomized Double-Blind Placebo-Controlled Trial With Multimodal Neuroimaging and Neurocognitive Assessments

The objective of this study is to demonstrate the cognitive enhancement effect and safety of Fermented Codonopsis lanceolata, 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.

Inclusion Criteria:

• Age between 20 and 65 years old
• Global Deterioration Scale score (GDS) of 2
• High school or higher levels of education
• With informed consent

Exclusion Criteria:

• 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 25 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
• Allergic adverse reactions to Fermented Codonopsis lanceolata
• Participation in other clinical trials during the study period that might affect the outcome of the present study
• Use of oral contraceptive medication
• Current pregnancy or breast-feeding