Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07334366
Eligibility Criteria:
Inclusion Criteria:
* Age: Adults aged 55-85 years (inclusive), both male and female
* Global Deterioration Scale (GDS) score of 2-3:
GDS 2: Subjective memory impairment without objective evidence GDS 3: Mild objective memory impairment
* Absence of dementia according to established diagnostic criteria
* Ability to read Korean
Exclusion Criteria:
* Severe medical conditions within the past 6 months: History of severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage), cardiac disease (angina, myocardial infarction, heart failure, arrhythmia requiring treatment), or malignancy (Note: Participants with a history of cerebrovascular or cardiac disease who are clinically stable may be included at the investigator's discretion)
* Cognitive impairment-associated diseases: Dementia, Parkinson's disease, cerebral infarction, or other conditions associated with cognitive decline Uncontrolled hypertension: Blood pressure ≥160/100 mmHg (measured after 10 minutes of rest)
* Poor glycemic control: Fasting blood glucose ≥160 mg/dL in diabetic patients
* Uncontrolled thyroid dysfunction: Currently receiving treatment for uncontrolled hypothyroidism or hyperthyroidism
* Renal impairment: Serum creatinine ≥2 times the upper limit of normal for the institution
* Hepatic impairment: AST or ALT ≥2 times the upper limit of normal for the institution
* Severe gastrointestinal symptoms: Complaints of severe heartburn, dyspepsia, or other gastrointestinal distress
* Medications affecting cognitive function within the past month: Use of drugs (antipsychotics, anti-degenerative agents, cognitive enhancers, tricyclic antidepressants, hormone replacement therapy) or health functional foods that may influence cognitive function due to dementia or other cognitive abnormalities
* Other clinical trial participation: Participation in other drug clinical trials within the past month or planned participation during the study period
* Alcohol use disorder, severe
* Food allergies: Known allergic reactions to study product components
* Investigator discretion: Any other condition deemed inappropriate for study participation by the investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
85 Years
Study:
NCT07334366
Study Brief:
Protocol Section:
NCT07334366