- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03439098
Effects of Fermented Codonopsis Lanceolata on Improvement in Cognitive-Bio-Markers of Cognitive Functions
August 12, 2019 updated by: In Kyoon Lyoo, Ewha Womans University
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 03760
- Ewha Womans University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
|
Placebo daily for 8 weeks
|
EXPERIMENTAL: Fermented Codonopsis lanceolata 525mg
Fermented Codonopsis lanceolata 525mg/day
|
Fermented Codonopsis lanceolata 525mg daily for 8 weeks
|
EXPERIMENTAL: Fermented Codonopsis lanceolata 1050mg
Fermented Codonopsis lanceolata 1050mg/day
|
Fermented Codonopsis lanceolata 1050mg daily for 8 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in standardized scores on a neuropsychological test battery
Time Frame: baseline, 4th week, 8th week
|
A composite z-scores were calculated from the scores of the neuropsychological test battery on attention and working memory.
The test battery included Letter-number sequencing, Digit span (forward), and tasks from the Cambridge Neuropsychological Test Automated Battery (CANTAB) including the Match-to-Sample Visual Search, Reaction Rime, Rapid Visual Information Processing, and Stop Signal tasks.
|
baseline, 4th week, 8th week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in scores of the Subjective Memory Complaints Questionnaire
Time Frame: baseline, 4th week, 8th week
|
The Subjective Memory Complaints Questionnaire (SMCQ) contains 14 items and consists of two domains: global memory function and everyday memory function.
The response to each item is rated as "yes" (1 point) or "no" (0 point).
The total score ranges from 0 to 14 points, and higher points indicate larger degrees of subjective memory complaints.
|
baseline, 4th week, 8th week
|
Number of participants with adverse events
Time Frame: 4th week, 8th week
|
4th week, 8th week
|
|
Changes of brain volume in magnetic resonance imaging assessed by computational approaches
Time Frame: baseline, 8th week
|
Volumes of the clusters in the brain are reported in cubic millimeters
|
baseline, 8th week
|
Changes of cortical thickness in magnetic resonance imaging assessed by computational approaches
Time Frame: baseline, 8th week
|
Cortical thickness is measured in millimeters.
|
baseline, 8th week
|
Functional brain changes in magnetic resonance imaging assessed by computational approaches
Time Frame: baseline, 8th week
|
The Blood Oxygenation Level Dependent (BOLD) signal intensities in arbitrary units are measured in each voxel of the brain.
These values are compared between the time points and groups, and the statistical values are presented as results.
|
baseline, 8th week
|
Metabolic brain changes in magnetic resonance imaging assessed by computational approaches
Time Frame: baseline, 8th week
|
Brain metabolite concentrations are assessed using the magnetic resonance spectroscopy and are estimated in mmol per liter.
|
baseline, 8th week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 6, 2015
Primary Completion (ACTUAL)
May 19, 2016
Study Completion (ACTUAL)
May 19, 2016
Study Registration Dates
First Submitted
December 28, 2015
First Submitted That Met QC Criteria
February 13, 2018
First Posted (ACTUAL)
February 20, 2018
Study Record Updates
Last Update Posted (ACTUAL)
August 14, 2019
Last Update Submitted That Met QC Criteria
August 12, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- EBI_CT_FCL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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