None listed
Conditions
Interventions
Dietary Supplement : Double-blinded, randomized NIHHS-24-001 or placebo is taken twice a day for 12 weeks, orally by taking 4 capsules, and placebo (in the placebo group, not the NIHHS-24-001 group) i
Sponsors
Chung-Ang Univerisity Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ?1) A person who voluntarily decided to participate in this study and signed a written informed consent2) A person aged 55 to 80 at the time of screening 3) A person who complains of mild cognitive decline but is not dementia 4) A person who has excluded structural brain lesions that may affect cognitive decline through the results of magnetic resonance imaging (MRI) within 24 months from the time of screening 5) A person who can read and write 6) A person who meets all of the following criteria ? Korean-version of Mini-Mental State Examination 2 (K-MMSE-2) = 15 ? Clinical Dementia Rating (CDR) = 0.5 ?? Modified Hachinski Ischemia Score (HIS) = 4
Exclusion criteria
Exclusion criteria: ?1) A person who has known hypersensitivity reactions to the components of the test food 2) A person who has a significant neurological condition or a medical history that is not a target disease at the time of screening 3) A person who falls under one or more of the following at the time of screening ? A person who has a significant history of psychiatric disorders or who currently has depression, such as schizophrenia or bipolar mental disorder, which may interfere with the participation of this study according to the opinion of the investigator ? Current history of clinically significant hypothyroidism ? A history of unstable or clinically significant cardiovascular disease, as judged by the investigator, falling under one or more of the following a. Myocardial infarction, unstable angina pectoris, heart failure, etc. within 6 months from the time of screening b. Poorly controlled atrial fibrillation, clinically significant sick sinus syndrome without a pacemaker inserted, or left bundle branch block syndrome, etc. within 12 months from the time of screening ? Current history of clinically significant vitamin 12 deficiency under the judgment of the investigator within 12 months from the time of screening ? Uncontrolled diabetes (HbA1c > 8.0%) 4) A person who meets any of the following criteria in the screening test results. ? Creatinine > 2.0 mg/dL ? AST, ALT, or ?-GTP more than twice the normal upper limit 5) A person who is administering a drug (separate list) that meets the exclusion criteria at the time of screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ?Neuropsychological test(K-MMSE-2);?QEEG;?AlzOn(MDS- OAb);?Neuropsychological test( CDR );?Neuropsychological test( ADAS-Cog-13 );?Neuropsychological test( ADCOMS );?Neuropsychological test( AQS );?Neuropsychological test( TMT-B&W);?Neuropsychological test(Clock drawing test) | — |
Secondary
| Measure | Time frame |
|---|---|
| ?Safety markers (adverse event, vital signs, physical examination, electrocardiogram, clinical laboratory test) | — |
Countries
Korea, Republic of
Contacts
Public ContactJUHEE Park
Chung-Ang Univerisity Hospital
Outcome results
None listed