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RecruitingPhase 4NCT05908695

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

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

Sponsor

Green Valley (Shanghai) Pharmaceuticals Co., Ltd.

Enrollment

1,312 participants

Start Date

Aug 31, 2023

Study Type

INTERVENTIONAL

Conditions

Alzheimer s Disease

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.

Eligibility

Min Age: 50 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a drug called sodium oligomannate (GV-971) — derived from seaweed — can slow the progression of Alzheimer's disease in people with mild to moderate symptoms. The drug is thought to work partly by influencing gut bacteria and reducing brain inflammation. **You may be eligible if...** - You have a diagnosis of mild to moderate Alzheimer's disease - Your cognitive decline has been gradual over at least 1 year - Your memory test score (MMSE) is between 11 and 24 - You have a reliable caregiver or study partner who can support your participation - Your brain MRI is most consistent with Alzheimer's disease **You may NOT be eligible if...** - You have another type of dementia (not Alzheimer's) - You have a significant brain abnormality on MRI other than Alzheimer's changes - Your resting heart rate is below 50 beats per minute - You have had a serious illness or unstable medical condition in the past year - You have been taking Alzheimer's medications such as donepezil, memantine, or aducanumab within the past 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGV-971

Administered PO

DRUGPlacebo

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

View Full Details on ClinicalTrials.gov

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NCT05908695

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