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A single-center open intervention research on the safety and efficacy of cholestyramine on mild cognitive impairment and mild to moderate Alzheimer's disease with dyslipidemia

A single-center open intervention research on the safety and efficacy of cholestyramine on mild cognitive impairment and mild to moderate Alzheimer's disease with dyslipidemia

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071225
Enrollment
Unknown
Registered
2023-05-08
Start date
2023-05-01
Completion date
Unknown
Last updated
2023-06-12

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

Conditions

Alzheimer's disease (AD)

Interventions

Mild cognitive impairment (MCI) group:Cholestyramine
Mild to moderate Alzheimer's disease group:Cholestyramine

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

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

MeasureTime frame
Alzheimer's disease assessment scale score;

Secondary

MeasureTime frame
Bile acid (BA) profiles;Total cholesterol (TC) level;

Countries

China

Contacts

Public ContactGuo Qihao, Jia Wei

Shanghai Sixth People's Hospital

dr.guoqihao@126.com+86 21 24056374

Outcome results

None listed

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