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A 12-week, Multi-center, Randomized, Double-blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of MPCO on Mild Cognitive Impairment

A 12-week, Multi-center, Randomized, Double-blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of MPCO on Mild Cognitive Impairment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0008219
Enrollment
150
Registered
2023-02-22
Start date
2021-09-29
Completion date
Unknown
Last updated
2023-03-06

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

Conditions

None listed

Interventions

Dietary Supplement : 1. Test group Main ingredient: MPCO Formulation: tablets Content: 800mg tablets Storage method: Store at room temperature 1 degree to 30 degrees Directions: Take 2 tablets once a

Sponsors

NINE B
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Men and women over 55 years old and under 85 years old 2) Those who can read Korean 3) A person whose memory score on CERAD-K decreased by more than 1.0 SD compared to the same education level and age group 4) A person who agreed to participate in this human application test before the human application test started and filled out the informed consent form

Exclusion criteria

Exclusion criteria: 1) Those currently undergoing treatment for severe immune system, respiratory system, gastrointestinal/liver and biliary system, kidney and urinary system, nervous system, musculoskeletal system, infectious diseases and malignant tumors You can participate at your discretion.) 2) Persons with mental illness such as depression, schizophrenia, alcoholism, drug dependence, etc. 3) Those with diseases accompanied by cognitive decline, such as dementia or Parkinson's 4) Those with a history of head trauma accompanied by loss of consciousness, cardiovascular disease (angina pectoris, myocardial infarction, transient ischemic attack, acute stroke, etc.) within 6 months of visit 1 5) Persons who have received estrogen replacement therapy within 2 months of visit 1 6) Those who have administered drugs (antipsychotics, drugs for degenerative diseases, brain function improvers, tricyclic antidepressants) that affect cognitive function within 4 weeks of visit 1 7) Those who have taken health functional foods related to cognitive function improvement within 2 weeks of visit 1 8) A person whose daily dose of vitamin E preparation is 400 IU or more or who is expected to not be able to reduce the dose 9) Thyroid disease patients with TSH of 0.1 or less or 10 or more 10) A person whose creatinine is twice the upper limit of normal at the implementing institution 11) A person whose AST or ALT is more than three times the upper limit of the implementing agency 12) Patients with uncontrolled hypertension 13) Patients with uncontrolled diabetes 14) Pregnant or lactating women or those who plan to become pregnant during this human application test 15) Those who are sensitive or allergic to food ingredients for this human application test 16) Those who have participated in other interventional clinical trials within 3 months of the start of this human application trial, or plan to participate in other interventional clinical trials after the start of this human application trial 17) Those who are judged unsuitable by the tester for other reasons

Design outcomes

Primary

MeasureTime frame
ADAS-cog 11 total score; ADAS-cog 13 memory domain score; ADAS-cog 13 total and subscores; Visual C.P.T (visual continuous test);ADCS-ADL (Acts of Daily Living Assessment); SGDS-K (Geriatric Depression Scale)

Secondary

MeasureTime frame
body measurements (weight); Vital signs (blood pressure, pulse);Clinical pathology test; Pregnancy test

Countries

Korea, Republic of

Contacts

Public ContactKang-Joon Lee

Inje University Ilsan Paik Hospital

lkj@paik.ac.kr+82-2-031-7262

Outcome results

None listed

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