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RECRUITING
NCT05908695
PHASE4

An Efficacy and Safety Study of Sodium Oligomannate (GV-971) for the Treatment of Alzheimer's Disease

Sponsor: Green Valley (Shanghai) Pharmaceuticals Co., Ltd.

View on ClinicalTrials.gov

Summary

The primary purpose of this study is to confirm the clinical efficacy and mechanism of action of GV-971, and identify incidence of known adverse reactions in long-term use and observe new adverse reactions, providing more guidance for clinical use.

Official title: A 36-week, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Evaluate the Efficacy and Safety of Sodium Oligomannate (GV-971) in Treatment of Mild to Moderate Alzheimer's Disease

Key Details

Gender

All

Age Range

50 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

1312

Start Date

2023-08-31

Completion Date

2029-12

Last Updated

2023-11-09

Healthy Volunteers

No

Interventions

DRUG

GV-971

Administered PO

DRUG

Placebo

Administered PO

Locations (50)

Huainan First People's Hospital

Huainan, Anhui, China

Beijing Anding Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Beijing Hospital

Beijing, Beijing Municipality, China

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Peking University Shougang Hospital

Beijing, Beijing Municipality, China

The First Medical Center, Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

The First Affiliated Hopsital of Xiamen University

Xiamen, Fujian, China

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, China

The Affiliated Brain Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

The First Affiliated Hopsital of Guangzhou Medical University

Guangzhou, Guangdong, China

The Second Affiliated Hopsital of Guangzhou Medical University

Guangzhou, Guangdong, China

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

The First People's Hospital of Nanning

Nanning, Guangxi, China

Shijiazhuang People's Hospital

Shijiazhuang, Hebei, China

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

The Second Hopsital of Hebei Medical University

Shijiazhuang, Hebei, China

Tangshan Workers' Hospital

Tangshan, Hebei, China

The First Affiliated Hopsital of Nanyang Medical College

Nanyang, Henan, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Wuhan Hospital of Traditional Chinese and Western Medicine (Wuhan No.1 Hospital)

Wuhan, Hubei, China

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Xiangya Hospital Central South University

Changsha, Hunan, China

Chenzhou First People's Hospital

Chenzhou, Hunan, China

Yueyang Central Hospital

Yueyang, Hunan, China

Huai'an Second People's Hospital

Huai'an, Jiangsu, China

Nanjing Brain Hospital

Nanjing, Jiangsu, China

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Yangzhou First People's Hospital

Yangzhou, Jiangsu, China

Jiujiang University Affiliated Hospital

Jiujiang, Jiangxi, China

The Second Affiliated Hopsital of Nanchang University

Nanchang, Jiangxi, China

The First Bethune Hospital of Jilin University

Changchun, Jilin, China

Inner Mongolia International Hospital of Mongolian Medicine

Hohhot, Neimenggu, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Shandong Provincial Hospital

Jinan, Shandong, China

Qilu Hospital of Shandong University (Qingdao)

Qingdao, Shandong, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Yantai Yuhuangding Hospital

Yantai, Shandong, China

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Xianyang Hospital of Yan'an University

Xianyang, Shanxi, China

The Second Affiliated Hospital of Air Force Medical University (Tangdu Hospital of Air Force Medical University)

Xi’an, Shanxi, China

Xi'an Mental Health Center

Xi’an, Shanxi, China

Hospital of Chengdu University of TCM

Chengdu, Sichuan, China

Tianjin People's Hospital

Tianjin, Tianjin Municipality, China

The Affiliated Hopsital of Inner Mongolia Medical University

Ürümqi, Xinjiang, China

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

The First Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

The Second Hospital of Jiaxing

Jiaxing, Zhejiang, China