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AzTrials

Alzheimer DiseasePhase 4NCT05181475

Long-term Efficacy and Safety Study of GV-971

A Phase 4 study testing Sodium Oligomannate Capsules (GV-971) in people with Alzheimer Disease, run by Green Valley (Shanghai) Pharmaceuticals Co., Ltd. at 40 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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… Read more about this study

Who is it for?
Ages 50 to 85 years
Conditions the study is for
Alzheimer Disease
What is being tested?
Sodium Oligomannate Capsules (GV-971)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
800 participants
Where
40 sitesChina
Study dates
7 Dec 2021to Jun 2025
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

40 sites in 1 country.

40 sites in 1 country

China40 sites

  • No.6 HeBei Provincial People's Hospital

    Baoding, Hebei

  • Beijing Chao-Yang Hospital

    Beijing, Beijing Municipality

  • Peking University Shougang Hospital

    Beijing, Beijing Municipality

  • Peking University Third Hospital

    Beijing, Beijing Municipality

  • The First Hospital of Changsha

    Changsha, Hunan

  • West China School of Medicine/West China Hospital of Sichuan University

    Chengdu, Sichuan

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

  • Affiliated Zhongshan Hospital of Dalian University

    Dalian, Liaoning

  • The Second Hospital of Dalian Medical University

    Dalian, Liaoning

  • The First People's Hospital of Foshan

    Foshan, Guangdong

  • Nanfang Hospital

    Guangzhou, Guangdong

  • The Affiliated Brain Hospital of Guangzhou Medical University

    Guangzhou, Guangdong

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • The Affiliated Hospital of Hangzhou Normal University

    Hangzhou, Zhejiang

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • Tongde Hospital of Zhejiang Province

    Hangzhou, Zhejiang

  • Zhejiang Hospital

    Hangzhou, Zhejiang

  • Central Hospital Affiliated to Shandong First Medical University

    Jinan, Shandong

  • The Second Hospital of Shandong University

    Jinan, Shandong

  • Lanzhou University Second Hospital

    Lanzhou, Gansu

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong

  • Shanghai 6th People's Hospital

    Shanghai, Shanghai Municipality

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality

  • Shanghai Mental Health Center

    Shanghai, Shanghai Municipality

  • Tongren Hospital Shanghai Jiao Tong University School Of Medicine

    Shanghai, Shanghai Municipality

  • Xinhua Hospital Affiliated To Shanghai Jiao tong University School of Medicine

    Shanghai, Shanghai Municipality

  • Zhongshan Hospital

    Shanghai, Shanghai Municipality

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong

  • Shenzhen People's Hospital

    Shenzhen, Guangdong

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei

  • Wuxi Mental Health Center

    Wuxi, Jiangsu

  • Wuxi No.2 People's Hospital

    Wuxi, Jiangsu

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu

Other trials in China

About this study

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

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.

Being tested
Sodium Oligomannate Capsules (GV-971)
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT05181475
Study groupRoleWhat they receive
Sodium Oligomannate Capsules (GV-971)ExperimentalThe recommended dose regimen for subjects: GV-971 450 mg (3 capsules) per dose, bid, po. in morning and evening
Receives: Drug: Sodium Oligomannate Capsules (GV-971)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, 48 weeks

Secondary outcomes (4)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 48 weeks, 96 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2022
  2. Study start7 Dec 2021
  3. Primary completionJan 2025 (estimated)
  4. Study completionJun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
800 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05181475
Sponsor's protocol ID
GV-971-PMS-B
Status last verified
Nov 2024
First submitted
2 Dec 2021
Last updated
15 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Sodium Oligomannate Capsules (GV-971) in people with Alzheimer Disease, run by Green Valley (Shanghai) Pharmaceuticals Co., Ltd. at 40 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in the ADAS-cog/11 score (time frame: Baseline, 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05181475.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.

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