Clinical trial to evaluate the effectiveness and safety of EEFE on cognitive function improvement
- Conditions
- Not Applicable
- Registration Number
- KCT0009469
- Lead Sponsor
- Ewha Womens University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method