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

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05908695
• Other study ID #: GV-971-PoCT
• Status: Recruiting
• Phase: Phase 4
• Start date: August 31, 2023
• Est. completion date: December 2029

Study information

• Verified date: November 2023
• Source: Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
• Contact: Medical Director, Ph. D
• Phone: +86 21 50504988
• Email: xinxianliang[@]greenvalleypharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1312
• Est. completion date: December 2029
• Est. primary completion date: June 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• GV-971
Administered PO
• Placebo
Administered PO

Locations

Country	Name	City	State
China	Beijing Anding Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Anzhen Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Hospital	Beijing	Beijing
China	Beijing Tongren Hospital, Capital Medical University	Beijing	Beijing
China	Peking University Shougang Hospital	Beijing	Beijing
China	The First Medical Center, Chinese PLA General Hospital	Beijing	Beijing
China	Xuanwu Hospital, Capital Medical University	Beijing	Beijing
China	The First Bethune Hospital of Jilin University	Changchun	Jilin
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan
China	Xiangya Hospital Central South University	Changsha	Hunan
China	Hospital of Chengdu University of TCM	Chengdu	Sichuan
China	Chenzhou First People's Hospital	Chenzhou	Hunan
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	The First Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Inner Mongolia International Hospital of Mongolian Medicine	Hohhot	Neimenggu
China	Huai'an Second People's Hospital	Huai'an	Jiangsu
China	Huainan First People's Hospital	Huainan	Anhui
China	The Second Hospital of Jiaxing	Jiaxing	Zhejiang
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	Shandong Provincial Hospital	Jinan	Shandong
China	Jiujiang University Affiliated Hospital	Jiujiang	Jiangxi
China	First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	The Second Affiliated Hopsital of Nanchang University	Nanchang	Jiangxi
China	Nanjing Brain Hospital	Nanjing	Jiangsu
China	The First People's Hospital of Nanning	Nanning	Guangxi
China	Affiliated Hospital of Nantong University	Nantong	Jiangsu
China	The First Affiliated Hopsital of Nanyang Medical College	Nanyang	Henan
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	Peking University Shenzhen Hospital	Shenzhen	Guangdong
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	Tianjin People's Hospital	Tianjin	Tianjin
China	The Affiliated Hopsital of Inner Mongolia Medical University	Urumqi	Xinjiang
China	Wuhan Hospital of Traditional Chinese and Western Medicine (Wuhan No.1 Hospital)	Wuhan	Hubei
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	The First Affiliated Hopsital of Xiamen University	Xiamen	Fujian
China	Xianyang Hospital of Yan'an University	Xianyang	Shanxi
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu
China	Yangzhou First People's Hospital	Yangzhou	Jiangsu
China	Yantai Yuhuangding Hospital	Yantai	Shandong
China	Yueyang Central Hospital	Yueyang	Hunan
China	Henan Provincial People's Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Green Valley (Shanghai) Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline on A-beta protein of CSF	Change from baseline on biomarkers of CSF A-beta protein after 36 weeks of treatment.	Baseline, 36 weeks
Other	Change from baseline on Tau protein of CSF	Change from baseline on biomarkers of CSF Tau protein after 36 weeks of treatment.	Baseline, 36 weeks
Other	Change from baseline on biomarkers of Th1/Th2 cell subtypes	Change from baseline on biomarkers of peripheral blood immune cell subtypes of Th1/Th2 after 36 weeks of treatment.	Baseline, 36 weeks
Primary	Change from baseline in the ADAS-cog/12 score	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.	Baseline, 36 weeks
Primary	Change from baseline in ADCS-ADL23 score	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.	Baseline, 36 weeks
Secondary	Change from baseline in MMSE score	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.	Baseline, 36 weeks
Secondary	Change from baseline in the CIBIC-Plus score	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.	Baseline, 36 weeks
Secondary	Change from baseline in NPI score	Change from baseline in Neuropsychiatric Inventory (NPI) score. The total score of NPI is 0-144, with higher scores mean a worse outcome.	Baseline, 36 weeks
Secondary	Change from baseline in ADCS-ADL23 score	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.	Baseline, 36 weeks