NCT05670912

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Capital Medical University · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	Wei Li Bai capsules	The distribution ratio between the groups was 1:1, and the stratification factor was the degree of illness CDR score. In the study, the entry of each subject into the active group or placebo group will be determined by the randomized system.
DRUG	Placebo Comparator of Wei Li Bai capsules	The distribution ratio between the groups was 1:1, and the stratification factor was the degree of illness CDR score. In the study, the entry of each subject into the active group or placebo group will be determined by the randomized system.

Timeline

• Start date: 2022-10-01
• Primary completion: 2024-11-12
• Completion: 2024-11-12
• First posted: 2023-01-04
• Last updated: 2024-12-04

Locations

3 sites across 1 country: China