drugset / Trial / NCT04780399

Efficacy and Safety of Yangxue Qingnao Pills in the Treatment of Mild to Moderate Alzheimer's Disease

NCT04780399 ↗

Phase 2 Unknown 216 enrolled Dongzhimen Hospital, Beijing
RandomizedParallel-groupQuadruple-blindTreatment

Summary

As a traditional Chinese medicine compound, Yangxue Qingnao Pills is proven to have beneficial effects on learning and memory ability in animal models of Alzheimer's disease(AD). The purpose of the study is to evaluate the efficacy and safety of Yangxue Qingnao Pills on patients with mild to moderate AD. This phase II randomized, double-blind, parallel controlled trial include a 2 weeks run-in period, and a 48 weeks double-blind treatment period of after randomization. Participants will be randomly allocated to Yangxue Qingnao pills high dose group (7.5 g per time,2 times per day) ; and Yangxue Qingnao pills low dose group (5 g per time,2 times per day), or placebo group. The outcome measures include general cognitive function, ability of daily living, and behavioural and psychological symptoms in AD patients.

Timeline

Start
2021-11-09
Primary completion
2024-03-01
Completion
2024-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Yangxue Qingnao pills Traditional medicine (herbal / TCM) 5 g Oral
Subject Yangxue Qingnao pills Traditional medicine (herbal / TCM) 7.5 g Oral

Indications