NCT03439098

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 6, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2016

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

February 20, 2018

Completed
Last Updated

August 14, 2019

Status Verified

August 1, 2019

Enrollment Period

11 months

First QC Date

December 28, 2015

Last Update Submit

August 12, 2019

Conditions

Subjective Memory Complaints

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline, 4th week, 8th week

Secondary Outcomes (6)

  • Changes in scores of the Subjective Memory Complaints Questionnaire

    baseline, 4th week, 8th week

  • Number of participants with adverse events

    4th week, 8th week

  • Changes of brain volume in magnetic resonance imaging assessed by computational approaches

    baseline, 8th week

  • Changes of cortical thickness in magnetic resonance imaging assessed by computational approaches

    baseline, 8th week

  • Functional brain changes in magnetic resonance imaging assessed by computational approaches

    baseline, 8th week

  • +1 more secondary outcomes

Study Arms (3)

Fermented Codonopsis lanceolata 525mg

EXPERIMENTAL

Fermented Codonopsis lanceolata 525mg/day

Dietary Supplement: Fermented Codonopsis lanceolata 525mg

Fermented Codonopsis lanceolata 1050mg

EXPERIMENTAL

Fermented Codonopsis lanceolata 1050mg/day

Dietary Supplement: Fermented Codonopsis lanceolata 1050mg

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

Fermented Codonopsis lanceolata 525mgDIETARY_SUPPLEMENT

Fermented Codonopsis lanceolata 525mg daily for 8 weeks

Fermented Codonopsis lanceolata 525mg
Fermented Codonopsis lanceolata 1050mgDIETARY_SUPPLEMENT

Fermented Codonopsis lanceolata 1050mg daily for 8 weeks

Fermented Codonopsis lanceolata 1050mg
PlaceboDIETARY_SUPPLEMENT

Placebo daily for 8 weeks

Placebo

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ewha Womans University

Seoul, 03760, South Korea

Location

Study Officials

  • Inkyoon Lyoo, MD, PhD, MMS

    Ewha Womans University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 28, 2015

First Posted

February 20, 2018

Study Start

July 6, 2015

Primary Completion

May 19, 2016

Study Completion

May 19, 2016

Last Updated

August 14, 2019

Record last verified: 2019-08

Locations

KR(1)