Alzheimer's DiseasePhase 4NCT05908695
An Efficacy and Safety Study of Sodium Oligomannate (GV-971) for the Treatment of Alzheimer's Disease
A Phase 4 study testing GV-971 in people with Alzheimer's Disease, run by Green Valley (Shanghai) Pharmaceuticals Co., Ltd. at 50 sites in China.
Trial summary
The primary purpose of this study is to confirm the clinical efficacy and mechanism of action of GV-971, and identify incidence of known adverse reactions in long-term use and observe new adverse reactions, providing more guidance for clinical use. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- GV-971
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,312 participants
- Where
- 50 sitesChina
- Study dates
- 31 Aug 2023to Dec 2029
- 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
- Mild to moderate AD per NIA-AA.
- History of cognitive and functional decline over at least 1 year.
- MMSE scores between 11 and 24 (inclusive) at baseline.
- Hachinski Ischemic Score (HIS) scale total score ≤ 4.
- Hamilton Rating Scale for Depression/17 items (HAMD) total score ≤ 10.
- Brain MRI scan show the highest possibility of AD.
- Have a reliable study partner/caregiver.
- Sign the informed consent form.
Who cannot join
- Diagnosis of a dementia-related central nervous system disease other than AD.
- Major structural brain disease as judged by MRI.
- A resting heart rate of < 50 beats per minute (bpm) after 10 minutes of rest.
- Major medical illness or unstable medical condition within 12 months of screening.
- Concomitant use of donepezil, rivastigmine, galanthamine, huperzine A, memantine, or aducanumab within 6 moinths prior to baseline.
- Inadequate hepatic function.
- Inadequate organ function.
- ECG clinically significant abnormalities.
Trial locations and contacts
50 sites in 1 country. Contact the study team or a site near you to ask about taking part.
50 sites in 1 country
China50 sites, 50 recruiting
- Not yet recruiting
Beijing Anding Hospital, Capital Medical University
Beijing, Beijing Municipality
Qinge Zhang
- Not yet recruiting
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality
Guangzhi Liu
- Not yet recruiting
Beijing Hospital
Beijing, Beijing Municipality
Haibo Chen
- Not yet recruiting
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality
Jiawei Wang
- Not yet recruiting
Peking University Shougang Hospital
Beijing, Beijing Municipality
Shudong Qiao
- Not yet recruiting
The First Medical Center, Chinese PLA General Hospital
Beijing, Beijing Municipality
Shengyuan Yu
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality
Jianping Jia
- Recruiting
The First Bethune Hospital of Jilin University
Changchun, Jilin
Li Sun
- Not yet recruiting
The Third Xiangya Hospital of Central South University
Changsha, Hunan
Deren Hou
- Not yet recruiting
Xiangya Hospital Central South University
Changsha, Hunan
Lu Shen
- Not yet recruiting
Hospital of Chengdu University of TCM
Chengdu, Sichuan
Dongdong Yang
- Not yet recruiting
Chenzhou First People's Hospital
Chenzhou, Hunan
Xiaoxi Yao
- Not yet recruiting
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong
Yefeng Cai
- Not yet recruiting
The Affiliated Brain Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Yuping Ning
- Not yet recruiting
The First Affiliated Hopsital of Guangzhou Medical University
Guangzhou, Guangdong
Qin Liu
- Recruiting
The Second Affiliated Hopsital of Guangzhou Medical University
Guangzhou, Guangdong
Jun Liu
- Not yet recruiting
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang
Guoping Peng
- Not yet recruiting
Inner Mongolia International Hospital of Mongolian Medicine
Hohhot, Neimenggu
Qile Temu
- Not yet recruiting
Huai'an Second People's Hospital
Huai'an, Jiangsu
Liandong Zhao
- Recruiting
Huainan First People's Hospital
Huainan, Anhui
Mei Zhang
Chuanqing Yu
- Recruiting
The Second Hospital of Jiaxing
Jiaxing, Zhejiang
Yanping Wang
- Not yet recruiting
Qilu Hospital of Shandong University
Jinan, Shandong
Yi Li
- Not yet recruiting
Shandong Provincial Hospital
Jinan, Shandong
Yifeng Du
- Recruiting
Jiujiang University Affiliated Hospital
Jiujiang, Jiangxi
Xiangbin Wu
- Not yet recruiting
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan
Xiufeng Xu
- Recruiting
The Second Affiliated Hopsital of Nanchang University
Nanchang, Jiangxi
Zhenyu Tang
- Not yet recruiting
Nanjing Brain Hospital
Nanjing, Jiangsu
Rong Lu
- Recruiting
The First People's Hospital of Nanning
Nanning, Guangxi
Xianfeng Li
- Not yet recruiting
Affiliated Hospital of Nantong University
Nantong, Jiangsu
Maohong Cao
- Not yet recruiting
The First Affiliated Hopsital of Nanyang Medical College
Nanyang, Henan
Qian Deng
- Not yet recruiting
Qilu Hospital of Shandong University (Qingdao)
Qingdao, Shandong
Chuanzhu Yan
- Not yet recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong
Yanping Sun
- Not yet recruiting
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Jianren Liu
- Not yet recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong
Xuhui Chen
- Recruiting
Shijiazhuang People's Hospital
Shijiazhuang, Hebei
Huiying Zhao
- Recruiting
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei
Qinying Ma
- Not yet recruiting
The Second Hopsital of Hebei Medical University
Shijiazhuang, Hebei
Yaling Liu
- Recruiting
Tangshan Workers' Hospital
Tangshan, Hebei
Yongqiu Li
- Not yet recruiting
Tianjin People's Hospital
Tianjin, Tianjin Municipality
Meiyun Zhang
- Not yet recruiting
The Affiliated Hopsital of Inner Mongolia Medical University
Ürümqi, Xinjiang
Chunyang Li
- Not yet recruiting
Wuhan Hospital of Traditional Chinese and Western Medicine (Wuhan No.1 Hospital)
Wuhan, Hubei
Wei Shao
- Not yet recruiting
The Second Affiliated Hospital of Air Force Medical University （Tangdu Hospital of Air Force Medical University）
Xi’an, Shanxi
Wei Zhang
- Not yet recruiting
Xi'an Mental Health Center
Xi’an, Shanxi
Wei Dang
- Not yet recruiting
The First Affiliated Hopsital of Xiamen University
Xiamen, Fujian
Kunmu Zheng
- Not yet recruiting
Xianyang Hospital of Yan'an University
Xianyang, Shanxi
Aihong Guo
- Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu
Guiyun Cui
- Not yet recruiting
Yangzhou First People's Hospital
Yangzhou, Jiangsu
Tieyu Tang
- Not yet recruiting
Yantai Yuhuangding Hospital
Yantai, Shandong
Zhigang Liang
- Not yet recruiting
Yueyang Central Hospital
Yueyang, Hunan
Xiang Huang
- Not yet recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan
Jiewen Zhang
About this study
Official title: A 36-week, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Evaluate the Efficacy and Safety of Sodium Oligomannate (GV-971) in Treatment of Mild to Moderate Alzheimer's Disease
The primary purpose of this study is to confirm the clinical efficacy and mechanism of action of GV-971, and identify incidence of known adverse reactions in long-term use and observe new adverse reactions, providing more guidance for clinical use.
- Conditions
- Alzheimer's Disease
- Being tested
- GV-971, Placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GV-971Drug
Administered PO
PlaceboDrug
Administered PO
| Study group | Role | What they receive |
|---|---|---|
| GV-971 | Experimental | Not described Receives: Drug: GV-971 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the ADAS-cog/12 score
Change from baseline in Alzheimer's Disease Assessments Scale - cognitive (ADAS-cog/12) scale total score. The total score of ADAS-cog/12 is 0-75, with higher scores mean a worse outcome.
Measured: Baseline, 36 weeks
Change from baseline in ADCS-ADL23 score
Change from baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living-23-item Scale (ADCS-ADL23) score in moderate AD participants. The total score of ADCS-ADL23 is 0-78, with higher scores mean a better outcome.
Measured: Baseline, 36 weeks
Secondary outcomes (4)
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, 36 weeks
Change from baseline in the CIBIC-Plus score
Change from baseline on Clinician's Interview-Based Impression of Change Plus (CIBIC-Plus) scale total score. The total score of CIBIC-Plus is 1-7, with higher scores mean a worse outcome.
Measured: Baseline, 36 weeks
Change from baseline in NPI score
Change from baseline in Neuropsychiatric Inventory (NPI) score. The total score of NPI is 0-144, with higher scores mean a worse outcome.
Measured: Baseline, 36 weeks
Change from baseline in ADCS-ADL23 score
Change from baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living-23-item Scale (ADCS-ADL23) score. The total score of ADCS-ADL23 is 0-78, with higher scores mean a better outcome.
Measured: Baseline, 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start31 Aug 2023
- Primary completionJun 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05908695
- Sponsor's protocol ID
- GV-971-PoCT
- Status last verified
- Nov 2023
- First submitted
- 31 May 2023
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 36-week, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Evaluate the Efficacy and Safety of Sodium Oligomannate (GV-971) in Treatment of Mild to Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05908695
- Acronym / sponsor ID
- GV-971-PoCT
- Conditions
- Alzheimer's Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,312 participants (estimated)
- Lead sponsor
- Green Valley (Shanghai) Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to confirm the clinical efficacy and mechanism of action of GV-971, and identify incidence of known adverse reactions in long-term use and observe new adverse reactions, providing more guidance for clinical use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GV-971 | Experimental | Drug: GV-971 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Mild to moderate AD per NIA-AA.
- History of cognitive and functional decline over at least 1 year.
- MMSE scores between 11 and 24 (inclusive) at baseline.
- Hachinski Ischemic Score (HIS) scale total score ≤ 4.
- Hamilton Rating Scale for Depression/17 items (HAMD) total score ≤ 10.
Key exclusion criteria (8 listed)
- Diagnosis of a dementia-related central nervous system disease other than AD.
- Major structural brain disease as judged by MRI.
- A resting heart rate of < 50 beats per minute (bpm) after 10 minutes of rest.
- Major medical illness or unstable medical condition within 12 months of screening.
- Concomitant use of donepezil, rivastigmine, galanthamine, huperzine A, memantine, or aducanumab within 6 moinths prior to baseline.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GV-971Administered PO | Drug | GV-971 |
| PlaceboAdministered PO | Drug | Placebo |
Primary outcome
Change from baseline in the ADAS-cog/12 score
Time frame: Baseline, 36 weeks
Change from baseline in Alzheimer's Disease Assessments Scale - cognitive (ADAS-cog/12) scale total score. The total score of ADAS-cog/12 is 0-75, with higher scores mean a worse outcome.
Change from baseline in ADCS-ADL23 score
Time frame: Baseline, 36 weeks
Change from baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living-23-item Scale (ADCS-ADL23) score in moderate AD participants. The total score of ADCS-ADL23 is 0-78, with higher scores mean a better outcome.
4 secondary outcomes
Change from baseline in MMSE score
Time frame: Baseline, 36 weeks
Change from baseline in the CIBIC-Plus score
Time frame: Baseline, 36 weeks
Change from baseline in NPI score
Time frame: Baseline, 36 weeks
Change from baseline in ADCS-ADL23 score
Time frame: Baseline, 36 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
50 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing GV-971 in people with Alzheimer's Disease, run by Green Valley (Shanghai) Pharmaceuticals Co., Ltd. at 50 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 8 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 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. Some participants in this study may receive a placebo. 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?
Contact Medical Director, Ph. D (+86 21 50504988 ext. 8821, xinxianliang@greenvalleypharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the ADAS-cog/12 score (time frame: Baseline, 36 weeks). 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?
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 9 Nov 2023.