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TERMINATEDPHASE2

Efficacy and Safety of Wei Li Bai Capsules in the Treatment of Alzheimer's Disease

A Randomized, Double-blind, Placebo-controlled, Multi-center II Clinical Trial to Evaluate the Efficacy and Safety of Wei Li Bai Capsules in the Treatment of Mild to Moderate Alzheimer's Disease

NCT05670912•Capital Medical University

View on ClinicalTrials.gov

Summary

In clinical trials of preclinical pharmacodynamic studies, Wei Li Bai capsules has been proved to significantly improve the learning and memory ability of Alzheimer's disease model. In this study, the researchers will use a multicenter, randomized, double-blind, placebo-controlled parallel method to recruit Alzheimer's disease patients to confirm the efficacy and safety of Wei Li Bai capsules. Confirmation of drug efficacy will be observed through changes in Alzheimer's disease patients' general cognitive function scores, scores of different cognitive domains, daily living activities, and symptom severities.

Detailed Description

Wei Li Bai Capsule is composed of sodium ferulate tablets, L-rhamnose and chrysin. Sodium ferulate tablet is a domestically marketed drug, L-rhamnose is a marketed food additive, and chrysin is a dietary supplement. All of them have been widely used and their safety has been confirmed. In addition, since these three compounds all show good potential in the treatment of Alzheimer's disease, and play an important role in regulating metabolism, improving blood circulation and anti-inflammatory and antioxidant, this study will explore the synergistic effect of Wei Libai capsule in patients with mild and moderate Alzheimer's disease in 130 subjects.

Eligibility

Age

50 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age 50 to 80 years old (including 50 and 80 years old), male or female;
•2. Meet the diagnostic criteria of "likely ad dementia" of the National Institute on aging Alzheimer's disease association (NIA-AA) (2011);
•3. The subjects are primary school graduates / graduates and above, and have the ability to complete the cognitive ability test and other tests specified in the program;
•4. Memory loss lasted for at least 6 months and tended to worsen gradually;
•5. Subjects with mild or moderate illness: 11 ≤ total score of MMSE ≤ 26;
•6. Total score of Clinical Dementia Rating Scale (CDR):
•Mild dementia: CDR = 1.0; Moderate dementia: CDR = 2.0;
•7. The total score of HIS ≤ 4;
•8. The total score of Hamilton Depression Scale (HAMD 17 item version) is ≤ 10;
•9. If the subject is currently receiving an approved AD treatment, such as acetylcholinesterase inhibitors (AChEI) and/or memantine, they must have been using a stable dose for at least 4 weeks prior to baseline and maintain a stable dose throughout the study;
+4 more criteria

Exclusion Criteria

•1. During screening, MRI examination showed significant focal lesions, fulfilling one of the following conditions:
•① There were more than 2 infarcts with diameter \> 2 cm at any site;
•② MRI examination showed that there were infarcts with arbitrary diameter in key parts (such as thalamus, hippocampus, entorhinal cortex, paraolfactory cortex, angular gyrus, cortex and other subcortical gray matter nuclei);
•③ Fazekas scale grade of white matter lesions \>2;
•④ There are other imaging evidences that do not support mild and moderate AD.
•2. Dementia caused by other reasons: vascular dementia, central nervous system infection, Creutzfeldt Jakob disease, Huntington's disease, Parkinson's disease, Lewy body dementia, traumatic dementia, other physical and chemical factors (such as drug poisoning, alcoholism, carbon monoxide poisoning, etc.), important physical diseases (such as hepatic encephalopathy, pulmonary encephalopathy, etc.), intracranial space occupying lesions (such as subdural hematoma, brain tumor), endocrine disorders (such as thyroid disease, parathyroid disease), and vitamin B12, folic acid deficiency or any other known cause;
•3. Have suffered from central nervous system diseases (including stroke, optic neuromyelitis, epilepsy, etc.);
•4. Subjects who were diagnosed with psychiatric disorders according to DSM-V criteria, including schizophrenia or other mental diseases, bipolar disorder, severe depression or delirium;
•5. Abnormal laboratory indexes: liver function (ALT and AST) exceeded 1.5×ULN, renal function (CR) exceeded 1.5×ULN, and creatine kinase exceeded 2×ULN;
•6. Untreated hypertensive and hypotensive subjects at screening, or hypertensive subjects with uncontrolled hypertension after treatment; subjects with good blood pressure control after treatment can be determined by the investigator to be suitable for inclusion in this study;
+10 more criteria

Locations (3)

China-Japan Friendship Hospital

Chaoyang, Beijing Municipality, China

Beijing Friendship Hospital, Capital Medical University

Beijing, China

Xuanwu Hospital of Capital Medical University

Beijing, China

Key Dates

Start Date

October 1, 2022

Primary Completion Date

November 12, 2024

Completion Date

November 12, 2024

Last Updated

December 4, 2024

Enrollment

105

ACTUAL participants

Conditions

Alzheimer Disease

Interventions

Wei Li Bai capsules

DRUG

Placebo Comparator of Wei Li Bai capsules

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 4, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy and Safety of Wei Li Bai Capsules in the Treatment of Alzheimer's Disease

Inclusion Criteria

Exclusion Criteria

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