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Alzheimer DiseasePhase 4NCT05058040

A Clinical Study to Evaluate the Long-Term Safety Sodium Oligomannate Capsules (GV-971)

A Phase 4 study testing Sodium Oligomannate Capsules in people with Alzheimer Disease, run by Green Valley (Shanghai) Pharmaceuticals Co., Ltd. at 63 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

A clinical study to evaluate the long-term safety of Sodium Oligomannate Capsules (GV-971) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Alzheimer Disease
What is being tested?
Sodium Oligomannate Capsules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,500 participants
Where
63 sitesChina
Study dates
2 Jun 2021to Apr 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects eligible for this study must meet all of the following criteria:
  • ≥18 years of age;
  • Signed informed consent form;
  • Patients receiving GV-971 treatment prescribed by clinicians;

Who cannot join

  • A subject may be excluded from participation in the study if any of the following apply:
  • 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

63 sites in 1 country.

63 sites in 1 country

China63 sites

  • Beijing Bo'ai Hospital

    Beijing, Beijing Municipality

  • Beijing Geriatric Hospital

    Beijing, Beijing Municipality

  • Beijing Luhe Hospital, Capital Medical University

    Beijing, Beijing Municipality

  • Dongfang Hospital Beijing University of Chinese Medicine

    Beijing, Beijing Municipality

  • Sanbo Brain Hospital Capital Medical University

    Beijing, Beijing Municipality

  • Chengdu Eighth People's Hospital

    Chengdu, Sichuan

  • Sichuan Academy of Medical Sciences sichuan Provincial People's Hospital

    Chengdu, Sichuan

  • Sichuan Baoshihua Hospital

    Chengdu, Sichuan

  • Chengdu Fourth People's Hospital

    Chengdu, Sichuang

  • The Fifth People's Hospital of Chengdu

    Chengdu, Sichuang

  • Chongqing 11th People's Hospital (Chongqing Special Care Hospital)

    Chongqing, Chongqing Municipality

  • Dongguan People's Hospital

    Dongguan, Guangdong

  • Red Cross Hospital of Guangzhou

    Guangzhou, Guangdong

  • The Third Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong

  • Zhujiang Hospital, Southern Medical University

    Guangzhou, Guangdong

  • Guihang Guiyang Hospital

    Guiyang, Guizhou

  • Second People's Hospital of Guizhou Province

    Guiyang, Guizhou

  • The First Affiliated Hospital of Guizhou University of Chinese Medicine

    Guiyang, Guizhou

  • The Second Affiliated Hospital of Guizhou University of Chinese Medicine

    Guiyang, Guizhou

  • Anhui Mental Health Center

    Hefei, Anhui

  • The First Affiliated Hospital of USTC(Anhui Provincial Hospital)

    Hefei, Anhui

  • Huzhou Third Municipal Hospital

    Huzhou, Zhejiang

  • Jinan Central Hospital Affiliated To Shandong University

    Jinan, Shandong

  • Shandong Mental Health Center

    Jinan, Shandong

  • Affiliated Hospital of Jining Medical University

    Jining, Shandong

  • Hebei Petro China Central Hospital

    Langfang, Hebei

  • Lianyungang Chinese Medicine Hospital

    Lianyungang, Jiangsu

  • The First People's Hospital of Lianyungang

    Lianyungang, Jiangsu

  • Liaocheng People's Hospital

    Liaocheng, Shandong

  • Nanchong Central Hospital

    Nanchong, Sichuang

  • Nanjing First Hospital

    Nanjing, Jiangsu

  • Nantong No.1 People's Hospital

    Nantong, Jiangsu

  • Huamei Hospital,University of Chinese Academy of Sciences

    Ningbo, Zhejiang

  • Ningbo First Hospital

    Ningbo, Zhejiang

  • Ningbo Kangning Hospital

    Ningbo, Zhejiang

  • General Hospital of North China Petroleum Administration (North China Hospital Affiliated to University of Chinese Academy of Sciences)

    Renqiu, Hebei

  • Huashan Hospital affiliated to Fudan University

    Shanghai, Shanghai Municipality

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality

  • Shanghai Fengxian District Central Hospital

    Shanghai, Shanghai Municipality

  • Shanghai Fifth People's Hospital,Fudan University

    Shanghai, Shanghai Municipality

  • Shanghai Pudong New Area People's Hospital

    Shanghai, Shanghai Municipality

  • Tong Ren Hospital,Shanghai Jiao Tong University School Of Medicine

    Shanghai, Shanghai Municipality

  • Shenzhen Luohu District People's Hospital

    Shenzhen, Guangdong

  • Shenzhen Second People's Hospital (The First Affiliated Hospital of Shenzhen University)

    Shenzhen, Guangdong

  • Changshu No.2 People's Hospital

    Suzhou, Jiangsu

  • Suzhou Guangji Hospital

    Suzhou, Jiangsu

  • Suzhou Municipal Hospital(Geriatrics)

    Suzhou, Jiangsu

  • Suzhou Municipal Hospital

    Suzhou, Jiangsu

  • Suzhou Ninth People's Hospital

    Suzhou, Jiangsu

  • Second hospital of Shanxi Medical University

    Taiyuan, Shanxi

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi

  • Taizhou Second People's Hospital

    Taizhou, Jiangsu

  • Weifang People's Hospital

    Weifang, Shandong

  • Wenzhou People's Hospital

    Wenzhou, Zhejiang

  • Wuhan Central Hospital

    Wuhan, Hubei

  • Wuhan Mental Health Center

    Wuhan, Hubei

  • Shanxi Provincial People's Hospital

    Xi’an, Shanxi

  • Xi 'an Baoshihua Changqing Hospital

    Xi’an, Shanxi

  • Xi'an Central Hospital

    Xi’an, Shanxi

  • Xiamen Xianyue Hospital

    Xianmencun, Fujian

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu

  • Zhenjiang mental health center

    Zhenjiang, Jiangsu

  • Zhuhai People's Hospital

    Zhuhai, Guangdong

Other trials in China

About this study

Official title: A Clinical Study to Evaluate the Long-Term Safety Sodium Oligomannate Capsules

A clinical study to evaluate the long-term safety of Sodium Oligomannate Capsules (GV-971)

Read the detailed description

Sodium oligomannate (Code: GV-971), a marine-derived oligosaccharide after extraction, separation and degradation from algae, can play a role in the treatment of Alzheimer's disease by reconditioning the dysbiosis of gut microbiota, preventing peripheral immune cells from invading the brain, inhibiting the inflammatory response in the brain, and targeting protein folding errors in the brain tissue. Phase I clinical study shows GV-971 was safe and tolerated in healthy adult volunteers when administered continuously at 1200 mg/dose or 1500 mg/day (750 mg/dose, bid) for 5 days. Phase II and III clinical studies show that the treatment of GV-971 at 900 mg/day dosage for 36 weeks can significantly improve the cognitive function of patients with mild to moderate Alzheimer's disease (AD) and was safe and well-tolerated.

Sodium Oligomannate Capsules obtained approval from China's National Medical Products Administration (NMPA) on November 2, 2019, with approval letter number of 2019S00571. This product is a chemical drug with a registration classification of 1.2. It is approved for the clinical indication of mild to moderate Alzheimer's disease and the function of improving the cognitive function of patients. The clinical dosage and administration is 3 capsules (450 mg)/time, bid, po.

Due to the limited number of subjects and observation period of medication in completed GV-971 clinical studies, and the screening of patients with the strict inclusion and exclusion criteria, the adverse reactions and long-term safety of GV-971 cannot be comprehensively observed and recorded. Therefore, according to the requirements of the NMPA for the marketing of new drugs, this study is intended to further carry out a post-marketing investigation on expanded population using a design of a 96-week intensive monitoring clinical trial to determine the incidence of known adverse reactions of GV-971 under long-term administration, observe the occurrence of new adverse reactions, analyze the correlation, incidence, severity, and risk factors of adverse reactions/events, and better guide the rational use of drugs in clinical practice.

Being tested
Sodium Oligomannate Capsules
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 CapsulesDrug

    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 NCT05058040
Study groupRoleWhat they receive
GV-971ExperimentalThe recommended dose regimen for subjects: GV-971 450 mg (3 capsules) per dose, bid, po. in morning and evening
Receives: Drug: Sodium Oligomannate Capsules

What is being measured

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

  1. Long-term safety of GV-971 in clinical practice during 48 weeks

    The incidence of adverse reactions and AE/SAE in patients treated with GV-971 during the 48-week monitoring period

    Measured: Week 48

  2. Long-term safety of GV-971 in clinical practice during 96 weeks

    The incidence of adverse reactions and AE/SAE in patients treated with GV-971 during the 96-week monitoring period

    Measured: Week 96

Secondary outcomes (2)

  1. Safety Endpoints: Vital signs, laboratory tests , electrocardiogram, and early withdrawal from the study during 48 weeks

    The incidence of adverse events and adverse reactions in patients with liver insufficiency and renal insufficiency receiving GV-971 during 48 weeks

    Measured: 48-week

  2. Safety Endpoints: Vital signs, laboratory tests , electrocardiogram, and early withdrawal from the study during 96 weeks

    The incidence of adverse events and adverse reactions in patients with liver insufficiency and renal insufficiency receiving GV-971 during 96 weeks

    Measured: 96-week

Timeline

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

  1. First posted27 Sep 2021
  2. Study start2 Jun 2021
  3. Primary completionJan 2025 (estimated)
  4. Study completionApr 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
2,500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05058040
Sponsor's protocol ID
GV-971-PMS-A
Status last verified
Nov 2024
First submitted
16 May 2021
Last updated
24 Jan 2025
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 in people with Alzheimer Disease, run by Green Valley (Shanghai) Pharmaceuticals Co., Ltd. at 63 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 4 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 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 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?

Long-term safety of GV-971 in clinical practice during 48 weeks (time frame: Week 48). The study lists 2 primary outcomes in all. 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 NCT05058040.

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 24 Jan 2025.

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