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Active, not recruitingNCT05181475Updated Nov 15, 2024

Long-term Efficacy and Safety Study of GV-971

A Phase 4 interventional study of Sodium Oligomannate Capsules (GV-971) in Alzheimer Disease, sponsored by Green Valley (Shanghai) Pharmaceuticals Co., Ltd.. Active, not recruiting at 40 sites in China. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-11-15.

Sponsored by Green Valley (Shanghai) Pharmaceuticals Co., Ltd. · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 9 months ago, but the record still lists the study as active, not recruiting.
Phase
Phase 4
Study type
Interventional
Enrollment
800
Allocation
Not applicable
Ages
50 Years to 85 Years
Sex
All
01

Study 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.

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Conditions studied

  • Alzheimer Disease

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03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 800 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Green Valley (Shanghai) Pharmaceuticals Co., Ltd. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
800 participants (actual)

Study arms

  • Experimental
    Sodium Oligomannate Capsules (GV-971)

    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

  • DrugSodium 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.

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What researchers measure

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.

    Time frame: Baseline, 48 weeks

Secondary outcomes

  1. 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.

    Time frame: Baseline, 96 weeks

  2. 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.

    Time frame: Baseline, 48 weeks, 96 weeks

  3. 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.

    Time frame: Baseline, 48 weeks, 96 weeks

  4. 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.

    Time frame: 48 weeks, 96 weeks

07

Study locations

40 sites
  • Beijing Chao-Yang Hospital
    Beijing, Beijing, China
  • Peking University Shougang Hospital
    Beijing, Beijing, China
  • Peking University Third Hospital
    Beijing, Beijing, China
  • The First Affiliated Hospital of Chongqing Medical University
    Chongqing, Chongqing, China
  • The Second Affiliated Hospital of Chongqing Medical University
    Chongqing, Chongqing, China
  • Lanzhou University Second Hospital
    Lanzhou, Gansu, China
  • The First Hospital of Lanzhou University
    Lanzhou, Gansu, 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
  • Peking University Shenzhen Hospital
    Shenzhen, Guangdong, China
  • Shenzhen People's Hospital
    Shenzhen, Guangdong, China
  • The Affiliated Hospital of Guizhou Medical University
    Guiyang, Guizhou, China
  • No.6 HeBei Provincial People's Hospital
    Baoding, Hebei, China
  • Union Hospital Tongji Medical College Huazhong University of Science and Technology
    Wuhan, Hubei, China
  • Zhongnan Hospital of Wuhan University
    Wuhan, Hubei, China
  • The First Hospital of Changsha
    Changsha, Hunan, China
  • The Second Affiliated Hospital of Nanjing Medical University
    Nanjing, Jiangsu, China
  • Wuxi Mental Health Center
    Wuxi, Jiangsu, China
  • Wuxi No.2 People's Hospital
    Wuxi, Jiangsu, China
  • Northern Jiangsu People's Hospital
    Yangzhou, Jiangsu, China
  • Affiliated Zhongshan Hospital of Dalian University
    Dalian, Liaoning, China
  • The Second Hospital of Dalian Medical University
    Dalian, Liaoning, China
  • Central Hospital Affiliated to Shandong First Medical University
    Jinan, Shandong, China
  • The Second Hospital of Shandong University
    Jinan, Shandong, 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
  • The First Affiliated Hospital of Xi'an Jiaotong University
    Xi'an, Shanxi, China
  • West China School of Medicine/West China Hospital of Sichuan University
    Chengdu, Sichuan, 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
  • The First Affiliated Hospital of Wenzhou Medical University
    Wenzhou, Zhejiang, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05181475
Lead sponsor
Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
Responsible party
Sponsor
First posted
Jan 6, 2022
Start date
Dec 7, 2021
Primary completion
Jan 2025 (estimated)
Completion
Jun 2025 (estimated)
Last update
Nov 15, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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