An Efficacy and Safety Study of Sodium Oligomannate (GV-971) for the Treatment of Alzheimer's Disease
- Registration Number
- NCT05908695
- Lead Sponsor
- Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1312
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GV-971 GV-971 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Change from baseline in the ADAS-cog/12 score Baseline, 36 weeks Change from baseline in Alzheimer's Disease Assessments Scale - cognitive (ADAS-cog/12) scale total score. The total score of ADAS-cog/12 is 0-75, with higher scores mean a worse outcome.
Change from baseline in ADCS-ADL23 score Baseline, 36 weeks Change from baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living-23-item Scale (ADCS-ADL23) score in moderate AD participants. The total score of ADCS-ADL23 is 0-78, with higher scores mean a better outcome.
- Secondary Outcome Measures
Name Time Method Change from baseline in the CIBIC-Plus score Baseline, 36 weeks Change from baseline on Clinician's Interview-Based Impression of Change Plus (CIBIC-Plus) scale total score. The total score of CIBIC-Plus is 1-7, with higher scores mean a worse outcome.
Change from baseline in ADCS-ADL23 score Baseline, 36 weeks Change from baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living-23-item Scale (ADCS-ADL23) score. The total score of ADCS-ADL23 is 0-78, with higher scores mean a better outcome.
Change from baseline in MMSE score Baseline, 36 weeks Change from baseline in Mini-Mental State Examination (MMSE) score. The total score of MMSE is 0-30, with higher scores mean a better outcome.
Change from baseline in NPI score Baseline, 36 weeks Change from baseline in Neuropsychiatric Inventory (NPI) score. The total score of NPI is 0-144, with higher scores mean a worse outcome.
Trial Locations
- Locations (50)
Peking University Shenzhen Hospital
🇨🇳Shenzhen, Guangdong, China
Beijing Anding Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
The Second Hopsital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Yantai Yuhuangding Hospital
🇨🇳Yantai, Shandong, China
The Second Affiliated Hospital of Air Force Medical University （Tangdu Hospital of Air Force Medical University）
🇨🇳Xi'an, Shanxi, China
Huainan First People's Hospital
🇨🇳Huainan, Anhui, China
Beijing Anzhen Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Hospital
🇨🇳Beijing, Beijing, China
Peking University Shougang Hospital
🇨🇳Beijing, Beijing, China
Beijing Tongren Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
The First Medical Center, Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China
Xuanwu Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Guangdong Provincial Hospital of Chinese Medicine
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hopsital of Xiamen University
🇨🇳Xiamen, Fujian, China
The First Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
The Affiliated Brain Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
The First People's Hospital of Nanning
🇨🇳Nanning, Guangxi, China
The First Affiliated Hopsital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
The Second Affiliated Hopsital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
Tangshan Workers' Hospital
🇨🇳Tangshan, Hebei, China
Shijiazhuang People's Hospital
🇨🇳Shijiazhuang, 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
Huai'an Second People's Hospital
🇨🇳Huai'an, Jiangsu, China
Chenzhou First People's Hospital
🇨🇳Chenzhou, Hunan, China
Nanjing Brain Hospital
🇨🇳Nanjing, Jiangsu, China
Yueyang Central Hospital
🇨🇳Yueyang, Hunan, China
Affiliated Hospital of Nantong University
🇨🇳Nantong, Jiangsu, China
The Second Affiliated Hopsital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Yangzhou First People's Hospital
🇨🇳Yangzhou, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, China
Jiujiang University Affiliated Hospital
🇨🇳Jiujiang, 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
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Xi'an Mental Health Center
🇨🇳Xi'an, Shanxi, China
Xianyang Hospital of Yan'an University
🇨🇳Xianyang, Shanxi, China
Hospital of Chengdu University of TCM
🇨🇳Chengdu, Sichuan, China
Tianjin People's Hospital
🇨🇳Tianjin, Tianjin, China
First Affiliated Hospital of Kunming Medical University
🇨🇳Kunming, Yunnan, China
The Affiliated Hopsital of Inner Mongolia Medical University
🇨🇳Urumqi, Xinjiang, China
The First Affiliated Hospital Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
The Second Hospital of Jiaxing
🇨🇳Jiaxing, Zhejiang, China