An Efficacy and Safety Study of Sodium Oligomannate (GV-971) for the Treatment of Alzheimer's Disease
About this study
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.
- Condition
- Alzheimer's Disease
- Tested
- GV-971, Placebo
- Sponsor
- Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
Who can join
- Age
- 50 to 85 years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 11
- Minimum age: 50 years
- Maximum age: 85 years
- Study condition: Alzheimer's Disease
- 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 8
- 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
50 sites, 50 recruiting
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
The Second Affiliated Hopsital of Guangzhou Medical University
Guangzhou, Guangdong, China
Huainan First People's Hospital
Huainan, Anhui, China
The Second Hospital of Jiaxing
Jiaxing, Zhejiang, China
Jiujiang University Affiliated Hospital
Jiujiang, Jiangxi, China
and 44 more sites on ClinicalTrials.gov
Contact
-
Medical Director, Ph. D
+86 21 50504988 xinxianliang@greenvalleypharma.com
Potential match only. Final eligibility is determined by the study team.