Mild Cognitive Impairment
Conditions
Interventions
Control group:treating MCI with placebos
Experimental group:treating MCI with fucoxanthin
Sponsors
Affiliated Kangning Hospital of Ningbo University
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 50 and 80 (inclusive) years old. 2. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Criteria: Cognitive decline: Modest cognitive decline in one or more cognitive domains from a previous level of functioning. Preserved daily functioning: The patient is able to independently complete activities of daily living. No dementia: Does not meet the diagnostic criteria for dementia. 3. Patients who had not received physical therapy of any form within 3 months prior to enrollment and had no plan to undergo physical therapy during the treatment period. 4. Subjects or their legal guardians must sign the informed consent form and be informed of the purpose, methods, potential risks of the screening, and other relevant information. If elderly individuals are unable to sign due to cognitive impairment, the form shall be signed on their behalf by their legal guardians.
Exclusion criteria
Exclusion criteria: 1. Participants with severe somatic diseases, such as severe heart disease or malignant tumors. 2. Participants with severe psychiatric symptoms or mental disorders,such as schizophrenia;those with alcohol or drug abuse;those with severe depression and significant suicide risk. 3. Participants Individuals who have taken sedative-hypnotic drugs within one week prior to enrollment;those whose use of sedative-hypnotic drugs has not been stable for at least four weeks;those who have undergone any form of physical therapy within the past three months;and those who have participated in any other drug clinical trials within the past six months.. 4. Dementia caused by other reasons:vascular dementia, central nervous system infections(such as AIDS, syphilis,etc.), Lewy body dementia,traumatic brain injury-related dementia, other physical and chemical factors(such as drug poisoning,etc.), intracranial space-occupying lesions (such as subdural hematoma, brain tumors), endocrine system disorders (such as thyroid diseases, parathyroid diseases), and dementia caused by vitamins or any other reasons. 5. Participants with the following abnormalities shown in medical history or cranial MRI screening:such as cerebral hemorrhage,traumatic brain injury, aneurysm, arteriovenous malformation, subdural hematoma, intracranial space-occupying lesions,etc. 6. Participants who, in the opinion of the investigator, should not participate in the study for other reasons; 7. Participants who do not sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of neuropsychiatric symptoms;Improvement of cognitive function; | — |
Secondary
| Measure | Time frame |
|---|---|
| To observe the improvement in anxiety and depressive symptoms.;Activities of Daily Living (ADL) Improvement;Safety Assessment;Trial Evaluation Indicator;Sleep Quality Improvement; | — |
Countries
China
Contacts
Public ContactZhao Zheng
Affiliated Kangning Hospital of Ningbo University
Outcome results
None listed