Treatment of Alzheimer's Disease with Sodium Oligomannate

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

This study is testing if a new drug called Sodium Oligomannate can help people with mild to moderate Alzheimer's Disease feel better and slow down their decline.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1312 (estimated)
• Ages: 50 Years to 85 Years
• Sex: All
• Sponsor: Green Valley (Shanghai) Pharmaceuticals Co., Ltd. (Industry-sponsored)
• Drugs / interventions: aducanumab
• Locations: 50 sites (Huainan, Anhui and 49 other locations)
• Trial ID: NCT05908695 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the efficacy and safety of Sodium Oligomannate (GV-971) in patients with mild to moderate Alzheimer's Disease. It will assess the drug's clinical effectiveness, its mechanism of action, and monitor both known and new adverse reactions over long-term use. Participants will receive either GV-971 or a placebo, and their cognitive and functional decline will be closely monitored throughout the study. The findings are expected to provide valuable insights for clinical use of this treatment.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with mild to moderate Alzheimer's Disease who have experienced cognitive decline for at least one year.

Not a fit: Patients with other types of dementia or significant medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve cognitive function and quality of life for patients with Alzheimer's Disease.

How similar studies have performed: Other studies have shown promise in treating Alzheimer's Disease with similar approaches, but the efficacy of GV-971 specifically is still being evaluated.

Eligibility criteria

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.

Where this trial is running

Huainan, Anhui and 49 other locations

• Huainan First People's Hospital — Huainan, Anhui, China (Recruiting)
• Beijing Anding Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Beijing Anzhen Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Beijing Hospital — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Beijing Tongren Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Peking University Shougang Hospital — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• The First Medical Center, Chinese PLA General Hospital — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Xuanwu Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
• The First Affiliated Hopsital of Xiamen University — Xiamen, Fujian, China (Not_yet_recruiting)
• Guangdong Provincial Hospital of Chinese Medicine — Guangzhou, Guangdong, China (Not_yet_recruiting)
• The Affiliated Brain Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Not_yet_recruiting)
• The First Affiliated Hopsital of Guangzhou Medical University — Guangzhou, Guangdong, China (Not_yet_recruiting)
• The Second Affiliated Hopsital of Guangzhou Medical University — Guangzhou, Guangdong, China (Recruiting)
• Peking University Shenzhen Hospital — Shenzhen, Guangdong, China (Not_yet_recruiting)
• The First People's Hospital of Nanning — Nanning, Guangxi, China (Recruiting)
• Shijiazhuang People's Hospital — Shijiazhuang, Hebei, China (Recruiting)
• The First Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Recruiting)
• The Second Hopsital of Hebei Medical University — Shijiazhuang, Hebei, China (Not_yet_recruiting)
• Tangshan Workers' Hospital — Tangshan, Hebei, China (Recruiting)
• The First Affiliated Hopsital of Nanyang Medical College — Nanyang, Henan, China (Not_yet_recruiting)
• Henan Provincial People's Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
• Wuhan Hospital of Traditional Chinese and Western Medicine (Wuhan No.1 Hospital) — Wuhan, Hubei, China (Not_yet_recruiting)
• The Third Xiangya Hospital of Central South University — Changsha, Hunan, China (Not_yet_recruiting)
• Xiangya Hospital Central South University — Changsha, Hunan, China (Not_yet_recruiting)
• Chenzhou First People's Hospital — Chenzhou, Hunan, China (Not_yet_recruiting)
• Yueyang Central Hospital — Yueyang, Hunan, China (Not_yet_recruiting)
• Huai'an Second People's Hospital — Huai'an, Jiangsu, China (Not_yet_recruiting)
• Nanjing Brain Hospital — Nanjing, Jiangsu, China (Not_yet_recruiting)
• Affiliated Hospital of Nantong University — Nantong, Jiangsu, China (Not_yet_recruiting)
• The Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China (Recruiting)
• Yangzhou First People's Hospital — Yangzhou, Jiangsu, China (Not_yet_recruiting)
• Jiujiang University Affiliated Hospital — Jiujiang, Jiangxi, China (Recruiting)
• The Second Affiliated Hopsital of Nanchang University — Nanchang, Jiangxi, China (Recruiting)
• The First Bethune Hospital of Jilin University — Changchun, Jilin, China (Recruiting)
• Inner Mongolia International Hospital of Mongolian Medicine — Hohhot, Neimenggu, China (Not_yet_recruiting)
• Qilu Hospital of Shandong University — Jinan, Shandong, China (Not_yet_recruiting)
• Shandong Provincial Hospital — Jinan, Shandong, China (Not_yet_recruiting)
• Qilu Hospital of Shandong University (Qingdao) — Qingdao, Shandong, China (Not_yet_recruiting)
• The Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (Not_yet_recruiting)
• Yantai Yuhuangding Hospital — Yantai, Shandong, China (Not_yet_recruiting)
• Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• Xianyang Hospital of Yan'an University — Xianyang, Shanxi, China (Not_yet_recruiting)
• The Second Affiliated Hospital of Air Force Medical University （Tangdu Hospital of Air Force Medical University） — Xi’an, Shanxi, China (Not_yet_recruiting)
• Xi'an Mental Health Center — Xi’an, Shanxi, China (Not_yet_recruiting)
• Hospital of Chengdu University of TCM — Chengdu, Sichuan, China (Not_yet_recruiting)
• Tianjin People's Hospital — Tianjin, Tianjin Municipality, China (Not_yet_recruiting)
• The Affiliated Hopsital of Inner Mongolia Medical University — Ürümqi, Xinjiang, China (Not_yet_recruiting)
• First Affiliated Hospital of Kunming Medical University — Kunming, Yunnan, China (Not_yet_recruiting)
• The First Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Not_yet_recruiting)
• The Second Hospital of Jiaxing — Jiaxing, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Medical Director, Ph. D

Conditions Alzheimer's Disease