Clinical trial NCT03439098: Effects of Fermented Codonopsis Lanceolata on Improvement in Cognitive-Bio-Markers of Cognitive Functions
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subjective Memory Complaints
Lead sponsor: Ewha Womans University
Sponsor class: OTHER
First posted: 2018-02-20
Enrollment: 60
Sex: ALL
Minimum age (years): 20
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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in standardized scores on a neuropsychological test battery
timeFrame: baseline, 4th week, 8th week
Secondary outcomes:
measure: Changes in scores of the Subjective Memory Complaints Questionnaire
timeFrame: baseline, 4th week, 8th week
measure: Number of participants with adverse events
timeFrame: 4th week, 8th week
measure: Changes of brain volume in magnetic resonance imaging assessed by computational approaches
timeFrame: baseline, 8th week
measure: Changes of cortical thickness in magnetic resonance imaging assessed by computational approaches
timeFrame: baseline, 8th week
measure: Functional brain changes in magnetic resonance imaging assessed by computational approaches
timeFrame: baseline, 8th week
measure: Metabolic brain changes in magnetic resonance imaging assessed by computational approaches
timeFrame: baseline, 8th week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University
Study officials:
affiliation: Ewha Womans University
name: Inkyoon Lyoo, MD, PhD, MMS
role: PRINCIPAL_INVESTIGATOR
References: