Subjective Memory ComplaintsNCT03439098
Effects of Fermented Codonopsis Lanceolata on Improvement in Cognitive-Bio-Markers of Cognitive Functions
A study testing Fermented Codonopsis lanceolata 525mg and Fermented Codonopsis lanceolata 1050mg in people with Subjective Memory Complaints, run by Ewha Womans University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Subjective Memory Complaints
- What is being tested?
- Fermented Codonopsis lanceolata 525mg and Fermented Codonopsis lanceolata 1050mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Jul 2015to 19 May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 20 and 65 years old
- Global Deterioration Scale score (GDS) of 2
- High school or higher levels of education
- With informed consent
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Subjective Memory Complaints
- Being tested
- Fermented Codonopsis lanceolata 525mg, Fermented Codonopsis lanceolata 1050mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fermented Codonopsis lanceolata 525mgDietary supplement
Fermented Codonopsis lanceolata 525mg daily for 8 weeks
Fermented Codonopsis lanceolata 1050mgDietary supplement
Fermented Codonopsis lanceolata 1050mg daily for 8 weeks
PlaceboDietary supplement
Placebo daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Fermented Codonopsis lanceolata 525mg | Experimental | Fermented Codonopsis lanceolata 525mg/day Receives: Dietary Supplement: Fermented Codonopsis lanceolata 525mg |
| Fermented Codonopsis lanceolata 1050mg | Experimental | Fermented Codonopsis lanceolata 1050mg/day Receives: Dietary Supplement: Fermented Codonopsis lanceolata 1050mg |
| Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in standardized scores on a neuropsychological test battery
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.
Measured: baseline, 4th week, 8th week
Secondary outcomes (6)
Changes in scores of the Subjective Memory Complaints Questionnaire
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.
Measured: baseline, 4th week, 8th week
Number of participants with adverse events
Measured: 4th week, 8th week
Changes of brain volume in magnetic resonance imaging assessed by computational approaches
Volumes of the clusters in the brain are reported in cubic millimeters
Measured: baseline, 8th week
Changes of cortical thickness in magnetic resonance imaging assessed by computational approaches
Cortical thickness is measured in millimeters.
Measured: baseline, 8th week
Functional brain changes in magnetic resonance imaging assessed by computational approaches
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.
Measured: baseline, 8th week
Metabolic brain changes in magnetic resonance imaging assessed by computational approaches
Brain metabolite concentrations are assessed using the magnetic resonance spectroscopy and are estimated in mmol per liter.
Measured: baseline, 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start6 Jul 2015
- Primary completion19 May 2016
- Study completion19 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjective Memory ComplaintsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ewha Womans University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In Kyoon Lyoo, Ewha Womans University
- Investigators
- Inkyoon Lyoo, MD, PhD, MMS, Principal investigator, Ewha Womans University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03439098
- Sponsor's protocol ID
- EBI_CT_FCL
- Status last verified
- Aug 2019
- First submitted
- 28 Dec 2015
- Last updated
- 14 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03439098
- Acronym / sponsor ID
- EBI_CT_FCL
- Conditions
- Subjective Memory Complaints
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ewha Womans UniversityUniversity, hospital or other
- Study start
- 6 Jul 2015 (actual)
- Primary completion
- 19 May 2016 (actual)
- Study completion
- 19 May 2016 (actual)
- First posted
- 20 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fermented Codonopsis lanceolata 525mg | Experimental | Dietary Supplement: Fermented Codonopsis lanceolata 525mgFermented Codonopsis lanceolata 525mg/day |
| Fermented Codonopsis lanceolata 1050mg | Experimental | Dietary Supplement: Fermented Codonopsis lanceolata 1050mgFermented Codonopsis lanceolata 1050mg/day |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 20 and 65 years old
- Global Deterioration Scale score (GDS) of 2
- High school or higher levels of education
- With informed consent
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fermented Codonopsis lanceolata 525mgFermented Codonopsis lanceolata 525mg daily for 8 weeks | Dietary supplement | Fermented Codonopsis lanceolata 525mg |
| Fermented Codonopsis lanceolata 1050mgFermented Codonopsis lanceolata 1050mg daily for 8 weeks | Dietary supplement | Fermented Codonopsis lanceolata 1050mg |
| PlaceboPlacebo daily for 8 weeks | Dietary supplement | Placebo |
Primary outcome
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.
6 secondary outcomes
Changes in scores of the Subjective Memory Complaints Questionnaire
Time frame: baseline, 4th week, 8th week
Number of participants with adverse events
Time frame: 4th week, 8th week
Changes of brain volume in magnetic resonance imaging assessed by computational approaches
Time frame: baseline, 8th week
Changes of cortical thickness in magnetic resonance imaging assessed by computational approaches
Time frame: baseline, 8th week
Functional brain changes in magnetic resonance imaging assessed by computational approaches
Time frame: baseline, 8th week
Metabolic brain changes in magnetic resonance imaging assessed by computational approaches
Time frame: baseline, 8th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Inkyoon Lyoo, MD, PhD, MMS principal investigator
Ewha Womans University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fermented Codonopsis lanceolata 525mg and Fermented Codonopsis lanceolata 1050mg in people with Subjective Memory Complaints, run by Ewha Womans University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in standardized scores on a neuropsychological test battery (time frame: baseline, 4th week, 8th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2019.