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Clinical trial to evaluate the effectiveness and safety of EEFE on cognitive function improvement

A 12-week, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of EEFE on cognitive function improvement

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0009469
Enrollment
80
Registered
2024-05-27
Start date
2024-05-30
Completion date
Unknown
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others(Health Functional Food) : Participants who voluntarily signed a consent form for human application research on visit 1 are judged whether they are suitable for participation according to the cr

Sponsors

Ewha Womens University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Those who agree to participate in this study before the test begins and submit a completed informed consent form 2) Men and women aged 55 to under 80 years old 3) Those who complain of subjective cognitive decline

Exclusion criteria

Exclusion criteria: 1) Individuals suspected of having dementia as a result of a neuropsychological examination 2) Those diagnosed with any Axis I psychiatric disorder 3) Those with major medical or surgical diseases requiring immediate treatment, according to their medical history, physical examination, neurological examination, or clinical pathology examination 4) Individuals with contraindications to MRI 5) Individuals with the following diseases: ? Malignant tumors, severe cerebrovascular disease, heart disease, or neuropsychiatric disorders requiring treatment ? A history of traumatic brain injury accompanied by loss of consciousness or convulsions within the past six months ? A history of acute stroke within the last three months ? Uncontrolled hypertension, diabetes, thyroid dysfunction, or kidney failure ? Severe hearing or vision impairment that makes functional evaluation impossible 6) Individuals who have taken anti-dementia drugs or brain metabolism enhancers in the past month 7) Those who have taken psychotropic drugs within the past three months 8) Those who have taken any drug or health functional food related to cognitive function, or foods similar to the test material within the past month 9) Those who have participated in other clinical trials (including human trials) within a month of the start of this human trial 10) Those with hypersensitivity to the ingredients in the investigational products or a history of severe allergic reactions 11) Individuals whom the principal investigator deems unsuitable for participation due to other reasons

Design outcomes

Primary

MeasureTime frame
Cambridge Neuropsychological Test Automated Battery

Secondary

MeasureTime frame
Neuropsychological test and cognitive functional questionnaire;Brain imaging;Safety-related indicators (vital signs, clinical pathological testing, adverse event);BDNF (Brain-Derived Neurotrophic Factor)

Countries

Korea, Republic of

Contacts

Public ContactChaewon Suh

Ewha Womens University

chaewon.s.suh@gmail.com+82-2-3277-6560

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026