Clinical trial to compare the cognitive function improvement effect of mature silkworm pills and nutritional beverage intake group and placebo pill and placebo beverage intake group in mild cognitive impairment
- Conditions
- Mental and behavioural disorders
- Registration Number
- KCT0007304
- Lead Sponsor
- Ajou University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 106
1. Patients with mild cognitive impairment who are 50 years of age or older as of the date of consent(For women who have lost fertility due to menopause or surgery, etc., those who have passed 2 years or more)
2. No significant impairment of daily life: K-IADL less than 0.4
3. It must not be dementia in the judgment of the clinician.
4. Can read and write letters.
5. Subject gave written consent to participate in the study.
1. If there is a mental illness such as major depression
2. Dementia
3. Other degenerative brain diseases such as Parkinson's disease
4. Malignant tumors within 5 years that have not been cured
5. Revascularization or stenting within 1 year
6. Severe or unstable symptomatic cardiovascular disease
7. Patients with other medical conditions that may interfere with completion of clinical trials if there is evidence of other severe or unstable physical disease
8. Severe visual impairment, severe hearing impairment, or communication impairment to the extent that interventions and effectiveness evaluations cannot be performed.
9. The illiterate
10. When it is judged that it is difficult for the researcher to cooperate fully in the research
11. If there is difficulty in safely participating in the research in the judgment of the researcher
12. Participating in other drug research or interventional research
13. If you are taking two or more prescription medications for cognitive decline
14. If more than 3 months have not elapsed since starting a new prescription for cognitive decline or adjusting the dose
15. Those who have a clear history of allergy to certain foods or drugs or who have been diagnosed
16. If you are taking other dietary supplements, if more than 3 months have not elapsed since starting or adjusting the dose
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method K-RBANS change amount
- Secondary Outcome Measures
Name Time Method Changes in K-MMSE, CDR, K-IADL, nutrient intake, blood markers(neurofilament light chain, amyloid ß, total tau, phosphorylated-tau), retention rate, intake compliance