Clinical Trials in China / NCT05908695
Recruiting
Phase 4
An Efficacy and Safety Study of Sodium Oligomannate (GV-971) for the Treatment of Alzheimer's Disease
NCT05908695 · tracked via the Priya Life Science China tracker
Condition(s) studied
Alzheimer's Disease
Investigational drug(s) / intervention(s)
GV-971 →Placebo
GV-971: Administered PO
Placebo: Administered PO
Study 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.
Eligibility
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
- Change from baseline in the ADAS-cog/12 score — 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 — 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.
Trial sites (50)
| Facility | City | Region | Status |
|---|---|---|---|
| Huainan First People's Hospital | Huainan | Anhui | Recruiting |
| Beijing Anding Hospital, Capital Medical University | Beijing | Beijing Municipality | Not Yet Recruiting |
| Beijing Anzhen Hospital, Capital Medical University | Beijing | Beijing Municipality | Not Yet Recruiting |
| Beijing Hospital | Beijing | Beijing Municipality | Not Yet Recruiting |
| Beijing Tongren Hospital, Capital Medical University | Beijing | Beijing Municipality | Not Yet Recruiting |
| Peking University Shougang Hospital | Beijing | Beijing Municipality | Not Yet Recruiting |
| The First Medical Center, Chinese PLA General Hospital | Beijing | Beijing Municipality | Not Yet Recruiting |
| Xuanwu Hospital, Capital Medical University | Beijing | Beijing Municipality | Recruiting |
| The First Affiliated Hopsital of Xiamen University | Xiamen | Fujian | Not Yet Recruiting |
| Guangdong Provincial Hospital of Chinese Medicine | Guangzhou | Guangdong | Not Yet Recruiting |
| The Affiliated Brain Hospital of Guangzhou Medical University | Guangzhou | Guangdong | Not Yet Recruiting |
| The First Affiliated Hopsital of Guangzhou Medical University | Guangzhou | Guangdong | Not Yet Recruiting |
| The Second Affiliated Hopsital of Guangzhou Medical University | Guangzhou | Guangdong | Recruiting |
| Peking University Shenzhen Hospital | Shenzhen | Guangdong | Not Yet Recruiting |
| The First People's Hospital of Nanning | Nanning | Guangxi | Recruiting |
| Shijiazhuang People's Hospital | Shijiazhuang | Hebei | Recruiting |
| The First Hospital of Hebei Medical University | Shijiazhuang | Hebei | Recruiting |
| The Second Hopsital of Hebei Medical University | Shijiazhuang | Hebei | Not Yet Recruiting |
| Tangshan Workers' Hospital | Tangshan | Hebei | Recruiting |
| The First Affiliated Hopsital of Nanyang Medical College | Nanyang | Henan | Not Yet Recruiting |
| Henan Provincial People's Hospital | Zhengzhou | Henan | Not Yet Recruiting |
| Wuhan Hospital of Traditional Chinese and Western Medicine (Wuhan No.1 Hospital) | Wuhan | Hubei | Not Yet Recruiting |
| The Third Xiangya Hospital of Central South University | Changsha | Hunan | Not Yet Recruiting |
| Xiangya Hospital Central South University | Changsha | Hunan | Not Yet Recruiting |
| Chenzhou First People's Hospital | Chenzhou | Hunan | Not Yet Recruiting |
| Yueyang Central Hospital | Yueyang | Hunan | Not Yet Recruiting |
| Huai'an Second People's Hospital | Huai'an | Jiangsu | Not Yet Recruiting |
| Nanjing Brain Hospital | Nanjing | Jiangsu | Not Yet Recruiting |
| Affiliated Hospital of Nantong University | Nantong | Jiangsu | Not Yet Recruiting |
| The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu | Recruiting |
| Yangzhou First People's Hospital | Yangzhou | Jiangsu | Not Yet Recruiting |
| Jiujiang University Affiliated Hospital | Jiujiang | Jiangxi | Recruiting |
| The Second Affiliated Hopsital of Nanchang University | Nanchang | Jiangxi | Recruiting |
| The First Bethune Hospital of Jilin University | Changchun | Jilin | Recruiting |
| Inner Mongolia International Hospital of Mongolian Medicine | Hohhot | Neimenggu | Not Yet Recruiting |
| Qilu Hospital of Shandong University | Jinan | Shandong | Not Yet Recruiting |
| Shandong Provincial Hospital | Jinan | Shandong | Not Yet Recruiting |
| Qilu Hospital of Shandong University (Qingdao) | Qingdao | Shandong | Not Yet Recruiting |
| The Affiliated Hospital of Qingdao University | Qingdao | Shandong | Not Yet Recruiting |
| Yantai Yuhuangding Hospital | Yantai | Shandong | Not Yet Recruiting |
+ 10 more sites — see the full list on the official registry below.
More Green Valley (Shanghai) Pharmaceuticals Co., Ltd. trials in China
A Clinical Study to Evaluate the Long-Term Safety Sodium Oligomannate Capsules (GV-971)
Active, not recruiting
Long-term Efficacy and Safety Study of GV-971
Active, not recruiting
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05908695 on ClinicalTrials.gov ↗ ← All trials in China