Brief 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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

800

participants targeted

Target at P75+ for phase_4 alzheimer-disease

Timeline

Completed

Started Dec 2021

Typical duration for phase_4 alzheimer-disease

Geographic Reach

1 country

40 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3.5 years study duration

First Submitted

Initial submission to the registry

December 2, 2021

Completed

5 days until next milestone

Study Start

First participant enrolled

December 7, 2021

Completed

1 month until next milestone

First Posted

Study publicly available on registry

January 6, 2022

Completed

3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed

Last Updated

November 15, 2024

Status Verified

November 1, 2024

Enrollment Period

3.1 years

First QC Date

December 2, 2021

Last Update Submit

November 13, 2024

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

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 Outcomes (4)

Change from baseline in ADAS-Cog/11 score
Baseline, 96 weeks
Change from baseline in MMSE score
Baseline, 48 weeks, 96 weeks
Change from baseline in ADCS-ADL score
Baseline, 48 weeks, 96 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
48 weeks, 96 weeks

Study Arms (1)

Sodium Oligomannate Capsules (GV-971)

EXPERIMENTAL

The recommended dose regimen for subjects: GV-971 450 mg (3 capsules) per dose, bid, po. in morning and evening

Drug: Sodium Oligomannate Capsules (GV-971)

Interventions

Sodium Oligomannate Capsules (GV-971)DRUG

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.

Sodium Oligomannate Capsules (GV-971)

Eligibility Criteria

Age50 Years - 85 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Aged 50 to 85 years (inclusive), with no restriction on gender;
Patients who met criteria for "probable AD" by National Institute on Aging and Alzheimer's Association (NIA-AA) diagnostic criteria;
Patients with mild to moderate AD as characterized by Mini-Mental State Examination (MMSE) scores between 11 and 26, inclusive;
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;
Patients receiving GV-971 treatment prescribed by clinicians;
Sign the informed consent form.

You may not qualify if:

Patients who have received GV-971 treatment within 6 months prior to screening;
Patients who may be allergic to Sodium Oligomannate Capsules as judged by the investigator;
Female participants who are pregnant or lactating;
Patients who cannot cooperate to complete the follow-up inquiries;
Any other diseases or conditions that are inappropriate to participate in this clinical trial in the opinion of the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Green Valley (Shanghai) Pharmaceuticals Co., Ltd.lead

Study Sites (40)

Beijing Chao-Yang Hospital

Beijing, Beijing Municipality, China

Location

Peking University Shougang Hospital

Beijing, Beijing Municipality, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Location

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Location

Lanzhou University Second Hospital

Lanzhou, Gansu, China

Location

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

Location

The First People's Hospital of Foshan

Foshan, Guangdong, China

Location

Nanfang Hospital

Guangzhou, Guangdong, China

Location

The Affiliated Brain Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

Location

Shenzhen People's Hospital

Shenzhen, Guangdong, China

Location

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Location

No.6 HeBei Provincial People's Hospital

Baoding, Hebei, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Location

The First Hospital of Changsha

Changsha, Hunan, China

Location

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Location

Wuxi Mental Health Center

Wuxi, Jiangsu, China

Location

Wuxi No.2 People's Hospital

Wuxi, Jiangsu, China

Location

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, China

Location

Affiliated Zhongshan Hospital of Dalian University

Dalian, Liaoning, China

Location

The Second Hospital of Dalian Medical University

Dalian, Liaoning, China

Location

Central Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, China

Location

The Second Hospital of Shandong University

Jinan, Shandong, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Location

Shanghai 6th People's Hospital