A human study to evaluate the effect of CKDB001 on Cognitive-enhancing functio
- Conditions
- Mental and behavioural disorders
- Registration Number
- KCT0009298
- Lead Sponsor
- Chong Kun Dang Bio
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
1) Individuals who have voluntarily given written informed consent after receiving sufficient explanation about this human application trial.
2) Adult men and women aged 55 to less than 80 years as of the date of written consent.
3) Individuals who are capable of understanding Korean.
4) Individuals whose score on the SVLT-E of the SNSB-II is decreased by more than 1.0 SD but less than 2.0 SD compared to the normal standard for the same education level and age group.
- Individuals with any of the following medical histories or surgical/procedural histories: diseases accompanied by cognitive impairment, history of mental illness that may affect this human application trial, history of infections affecting brain function, severe concomitant diseases/disabilities deemed unsuitable for study participation by the researcher, etc.
- Individuals who have taken the following drugs and food within 4 weeks of Visit 2 (Baseline): those who have been administered or are expected to be administered during the study period drugs that can affect cognitive function, those who have continuously consumed or are expected to consume health functional foods or dietary supplements related to cognitive and memory improvement, etc.
- Individuals with hypersensitivity to any component of the test food or other allergies deemed unsuitable for study participation by the researcher's opinion.
- Pregnant or breastfeeding women.
- Women of childbearing potential and men who are unwilling or unable to use appropriate contraception methods during the study period.
- Individuals who have participated in another study involving clinical trial drugs, foods, or medical devices within the past 3 months.
- Any other reasons deemed by the researcher as inappropriate for conducting the study.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in total ADAS-cog-13 score at 12 weeks compared to baseline.
- Secondary Outcome Measures
Name Time Method Change in DST (Digit Span Test) score at 12 weeks compared to baseline.;Change in TMT (Trail Making Test) score at 12 weeks compared to baseline.;Change in Stroop Test score at 12 weeks compared to baseline.;Change in Cytokine levels at 12 weeks compared to baseline.