An Efficacy and Safety Study of Sodium Oligomannate (GV-971) for the Treatment of Alzheimer's Disease
Recruiting · NCT05908695 · Interventional (participants receive a specific treatment) · Lead sponsor: Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
GV-971Placebo
What this trial is about
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.
Who can take part
Age range
50 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Mild to moderate AD per NIA-AA.
- History of cognitive and functional decline over at least 1 year.
- MMSE scores between 11 and 24 (inclusive) at baseline.
- Hachinski Ischemic Score (HIS) scale total score ≤ 4.
- Hamilton Rating Scale for Depression/17 items (HAMD) total score ≤ 10.
- Brain MRI scan show the highest possibility of AD.
- Have a reliable study partner/caregiver.
- Sign the informed consent form.
Exclusion criteria
- Diagnosis of a dementia-related central nervous system disease other than AD.
- Major structural brain disease as judged by MRI.
- A resting heart rate of \< 50 beats per minute (bpm) after 10 minutes of rest.
- Major medical illness or unstable medical condition within 12 months of screening.
- Concomitant use of donepezil, rivastigmine, galanthamine, huperzine A, memantine, or aducanumab within 6 moinths prior to baseline.
- Inadequate hepatic function.
- Inadequate organ function.
- ECG clinically significant abnormalities.
Where it is running
50 locations listed.
- 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