Alzheimer's disease (AD)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Chinese who can speak Mandarin; 2. Aged 50-80 years; 3. MCI or mild to moderate AD patients with dyslipidemia; 4. Voluntary participation and informed consent co-signed by legal guardian.
Exclusion criteria
Exclusion criteria: 1. During the screening period, MRI examination showed significant focal lesions, including one of the following: (1) HIS total score >4; (2) There were infarcts in key areas such as thalamus, hippocampus, entorhinal cortex, parorhinal cortex, angular gyrus, cortex and other subcortical gray matter nuclei; (3) Fazekas Scale of white matter lesion >=3. 2. Other causes of dementia. 3. History of central nervous system diseases (including stroke, optic neuromyelitis, Parkinson's disease/disease, epilepsy, etc.). 4. Psychiatric patients, according to the DSM-V criteria, include schizophrenia or other mental illness, bipolar disorder, major depression, or delirium. 5. Within 3 months of the screening visit, the subject had a newly emerged or ongoing unstable or serious disease of the heart, lung, liver, kidney, thyroid, or hematopoietic system, according to the investigator's judgment, and was not eligible for clinical study. 6. Patients with a history of malignant tumor or who are expected to receive the following treatments: radiotherapy, cytotoxic chemotherapy drugs and immunosuppressive drugs. 7. Were using any weight-reducing chemicals, herbal preparations or dietary additives, participating in a weight-loss program or following a special diet before screening. 8. Allergic to the drug or its components. 9. Patients with unexplained history of syncope, needle fainting or blood fainting. 10. Patients with difficulty in venous blood collection or who cannot tolerate venipuncture. 11. Alcohol or drug abusers. 12. Uncorrectable visual and hearing disorders and inability to complete neuropsychological tests and scale evaluations. 13. Participated in other clinical trials within 3 months prior to screening visit. 14. Have taken or are taking study drugs in the last 6 months. 15. Patients who are allergic to research drugs. 16. Complete biliary tract occlusion. 17. There were other circumstances in which participation in the study was not considered appropriate by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alzheimer's disease assessment scale score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bile acid (BA) profiles;Total cholesterol (TC) level; | — |
Countries
China
Contacts
Shanghai Sixth People's Hospital