Actively Recruiting
An Efficacy and Safety Study of Sodium Oligomannate (GV-971) for the Treatment of Alzheimer's Disease
Led by Green Valley (Shanghai) Pharmaceuticals Co., Ltd. · Updated on 2023-11-09
1312
Participants Needed
50
Research Sites
326 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
An Efficacy and Safety Study of Sodium Oligomannate (GV-971) for the Treatment of Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with mild to moderate Alzheimer's disease according to NIA-AA criteria
- History of cognitive and functional decline for at least 1 year
- MMSE score between 11 and 24 inclusive at baseline
- Hachinski Ischemic Score (HIS) of 4 or less
- Hamilton Rating Scale for Depression (HAMD) score of 10 or less
- Brain MRI showing highest likelihood of Alzheimer's disease
- Have a reliable caregiver or study partner
- Signed informed consent form
You will not qualify if you...
- Diagnosis of dementia-related central nervous system diseases other than Alzheimer's disease
- Major structural brain disease seen on MRI
- Resting heart rate below 50 beats per minute after 10 minutes of rest
- Major or unstable medical illness within 12 months before screening
- Use of donepezil, rivastigmine, galanthamine, huperzine A, memantine, or aducanumab within 6 months before baseline
- Inadequate liver function
- Inadequate other organ function
- Clinically significant abnormalities on ECG
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 50 locations
1
Huainan First People's Hospital
Huainan, Anhui, China
Actively Recruiting
2
Beijing Anding Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Not Yet Recruiting
3
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Not Yet Recruiting
4
Beijing Hospital
Beijing, Beijing Municipality, China
Not Yet Recruiting
5
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Not Yet Recruiting
6
Peking University Shougang Hospital
Beijing, Beijing Municipality, China
Not Yet Recruiting
7
The First Medical Center, Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Not Yet Recruiting
8
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Actively Recruiting
9
The First Affiliated Hopsital of Xiamen University
Xiamen, Fujian, China
Not Yet Recruiting
10
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, China
Not Yet Recruiting
11
The Affiliated Brain Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Not Yet Recruiting
12
The First Affiliated Hopsital of Guangzhou Medical University
Guangzhou, Guangdong, China
Not Yet Recruiting
13
The Second Affiliated Hopsital of Guangzhou Medical University
Guangzhou, Guangdong, China
Actively Recruiting
14
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
Not Yet Recruiting
15
The First People's Hospital of Nanning
Nanning, Guangxi, China
Actively Recruiting
16
Shijiazhuang People's Hospital
Shijiazhuang, Hebei, China
Actively Recruiting
17
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Actively Recruiting
18
The Second Hopsital of Hebei Medical University
Shijiazhuang, Hebei, China
Not Yet Recruiting
19
Tangshan Workers' Hospital
Tangshan, Hebei, China
Actively Recruiting
20
The First Affiliated Hopsital of Nanyang Medical College
Nanyang, Henan, China
Not Yet Recruiting
21
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Not Yet Recruiting
22
Wuhan Hospital of Traditional Chinese and Western Medicine (Wuhan No.1 Hospital)
Wuhan, Hubei, China
Not Yet Recruiting
23
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Not Yet Recruiting
24
Xiangya Hospital Central South University
Changsha, Hunan, China
Not Yet Recruiting
25
Chenzhou First People's Hospital
Chenzhou, Hunan, China
Not Yet Recruiting
26
Yueyang Central Hospital
Yueyang, Hunan, China
Not Yet Recruiting
27
Huai'an Second People's Hospital
Huai'an, Jiangsu, China
Not Yet Recruiting
28
Nanjing Brain Hospital
Nanjing, Jiangsu, China
Not Yet Recruiting
29
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
Not Yet Recruiting
30
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Actively Recruiting
31
Yangzhou First People's Hospital
Yangzhou, Jiangsu, China
Not Yet Recruiting
32
Jiujiang University Affiliated Hospital
Jiujiang, Jiangxi, China
Actively Recruiting
33
The Second Affiliated Hopsital of Nanchang University
Nanchang, Jiangxi, China
Actively Recruiting
34
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
Actively Recruiting
35
Inner Mongolia International Hospital of Mongolian Medicine
Hohhot, Neimenggu, China
Not Yet Recruiting
36
Qilu Hospital of Shandong University
Jinan, Shandong, China
Not Yet Recruiting
37
Shandong Provincial Hospital
Jinan, Shandong, China
Not Yet Recruiting
38
Qilu Hospital of Shandong University (Qingdao)
Qingdao, Shandong, China
Not Yet Recruiting
39
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Not Yet Recruiting
40
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Not Yet Recruiting
41
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
42
Xianyang Hospital of Yan'an University
Xianyang, Shanxi, China
Not Yet Recruiting
43
The Second Affiliated Hospital of Air Force Medical University （Tangdu Hospital of Air Force Medical University）
Xi’an, Shanxi, China
Not Yet Recruiting
44
Xi'an Mental Health Center
Xi’an, Shanxi, China
Not Yet Recruiting
45
Hospital of Chengdu University of TCM
Chengdu, Sichuan, China
Not Yet Recruiting
46
Tianjin People's Hospital
Tianjin, Tianjin Municipality, China
Not Yet Recruiting
47
The Affiliated Hopsital of Inner Mongolia Medical University
Ürümqi, Xinjiang, China
Not Yet Recruiting
48
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Not Yet Recruiting
49
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Not Yet Recruiting
50
The Second Hospital of Jiaxing
Jiaxing, Zhejiang, China
Actively Recruiting
Research Team
M
Medical Director, Ph. D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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