Long-term Efficacy and Safety Study of GV-971

Alzheimer Disease Clinical Trial

Official title:

A Clinical Study to Evaluate the Long-term Efficacy and Safety of Sodium Oligomannate Capsules (GV-971)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05181475
• Other study ID #: GV-971-PMS-B
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: December 7, 2021
• Est. completion date: June 2025

Study information

• Verified date: May 2023
• Source: Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Sodium Oligomannate Capsules (GV-971) has been approved for treatment of mild to moderate Alzheimer's disease and improving the cognitive function of patients. This study plans to observe, in the clinical patients, the long-term efficacy and safety of GV-971, as well as the changes in blood and gut microbiota biomarkers after treatment, to validate the mechanism of action of GV-971, in order to better guide the rational use of drug in clinical practice.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 800
• Est. completion date: June 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Aged 50 to 85 years (inclusive), with no restriction on gender;

2. Patients who met criteria for "probable AD" by National Institute on Aging and Alzheimer's Association (NIA-AA) diagnostic criteria;

3. Patients with mild to moderate AD as characterized by Mini-Mental State Examination (MMSE) scores between 11 and 26, inclusive;

4. Patients who have received at least primary education and have capacity to complete the measurement of cognition and other tests as specified in the protocol;

5. Patients receiving GV-971 treatment prescribed by clinicians;

6. Sign the informed consent form.

Exclusion Criteria:

1. Patients who have received GV-971 treatment within 6 months prior to screening;

2. Patients who may be allergic to Sodium Oligomannate Capsules as judged by the investigator;

3. Female participants who are pregnant or lactating;

4. Patients who cannot cooperate to complete the follow-up inquiries;

5. Any other diseases or conditions that are inappropriate to participate in this clinical trial in the opinion of the investigator.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• Sodium Oligomannate Capsules (GV-971)
Sodium Oligomannate Capsules, each capsule contains 150 mg of sodium oligomannate. The recommended treatment is oral administration, 450 mg (3 capsules) per dose, bid, in morning and evening.

Locations

Country	Name	City	State
China	No.6 HeBei Provincial People's Hospital	Baoding	Hebei
China	Beijing Chao-Yang Hospital	Beijing	Beijing
China	Peking University People's Hospital	Beijing	Beijing
China	Peking University Shougang Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	The First Hospital of Changsha	Changsha	Hunan
China	Sichuan Academy of Medical Sciences·Sichuan Provincial People's Hospital	Chengdu	Sichuan
China	West China School of Medicine/West China Hospital of Sichuan University	Chengdu	Sichuan
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	The Second Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	Affiliated Zhongshan Hospital of Dalian University	Dalian	Liaoning
China	The Second Hospital of Dalian Medical University	Dalian	Liaoning
China	The First People's Hospital of Foshan	Foshan	Guangdong
China	Nanfang Hospital	Guangzhou	Guangdong
China	The Affiliated Brain Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	The Affiliated Hospital of Guizhou Medical University	Guiyang	Guizhou
China	Sir Run Run Shaw Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The Affiliated Hospital of Hangzhou Normal University	Hangzhou	Zhejiang
China	The Second Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Tongde Hospital of Zhejiang Province	Hangzhou	Zhejiang
China	Zhejiang Hospital	Hangzhou	Zhejiang
China	Central Hospital Affiliated to Shandong First Medical University	Jinan	Shandong
China	The Second Hospital of Shandong University	Jinan	Shandong
China	Lanzhou University Second Hospital	Lanzhou	Gansu
China	The First Hospital of Lanzhou University	Lanzhou	Gansu
China	The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong
China	Shanghai 6th People's Hospital	Shanghai	Shanghai
China	Shanghai East Hospital	Shanghai	Shanghai
China	Shanghai Mental Health Center	Shanghai	Shanghai
China	Tongren Hospital Shanghai Jiao Tong University School Of Medicine	Shanghai	Shanghai
China	Xinhua Hospital Affiliated To Shanghai Jiao tong University School of Medicine	Shanghai	Shanghai
China	Zhongshan Hospital	Shanghai	Shanghai
China	Peking University Shenzhen Hospital	Shenzhen	Guangdong
China	Shenzhen People's Hospital	Shenzhen	Guangdong
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	Union Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan	Hubei
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei
China	Wuxi Mental Health Center	Wuxi	Jiangsu
China	Wuxi No.2 People's Hospital	Wuxi	Jiangsu
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi
China	Northern Jiangsu People's Hospital	Yangzhou	Jiangsu

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
Primary	Change from baseline in the ADAS-cog/11 score	Change from baseline in Alzheimer's Disease Assessments Scale - cognitive (ADAS-cog/11) scale total score. The total score of ADAS-cog/11 is 0-70, with higher scores mean a worse outcome.	Baseline, 48 weeks
Secondary	Change from baseline in ADAS-Cog/11 score	Change from baseline in Alzheimer's Disease Assessments Scale - cognitive (ADAS-cog/11) scale total score. The total score of ADAS-cog/11 is 0-70, with higher scores mean a worse outcome.	Baseline, 96 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, 48 weeks, 96 weeks
Secondary	Change from baseline in ADCS-ADL score	Change from baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living; 23-item Scale (ACDS-ADL23) score. The total score of ADCS-ADL23 is 0-78, with higher scores mean a better outcome.	Baseline, 48 weeks, 96 weeks
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	The incidence of adverse events and adverse reactions of vital signs, laboratory tests, electrocardiogram, and early withdrawal from the study in patients treated with GV-971.	48 weeks, 96 weeks