An Efficacy and Safety Study of Sodium Oligomannate (GV-971) for the Treatment of Alzheimer's Disease

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT05908695

Run by

Green Valley (Shanghai) Pharmaceuticals Co., Ltd.

People needed

1312

Starts

2023-08-31

Expected to finish

2029-12-01

Last updated by the study team

2023-11-09

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• The First Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (enrolling)
• The Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China (enrolling)
• The Second Affiliated Hopsital of Guangzhou Medical University — Guangzhou, Guangdong, China (enrolling)
• Jiujiang University Affiliated Hospital — Jiujiang, Jiangxi, China (enrolling)
• The Second Affiliated Hopsital of Nanchang University — Nanchang, Jiangxi, China (enrolling)
• Huainan First People's Hospital — Huainan, Anhui, China (enrolling)
• The First Bethune Hospital of Jilin University — Changchun, Jilin, China (enrolling)
• Tangshan Workers' Hospital — Tangshan, Hebei, China (enrolling)
• Xuanwu Hospital, Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
• The First People's Hospital of Nanning — Nanning, Guangxi, China (enrolling)
• Shijiazhuang People's Hospital — Shijiazhuang, Hebei, China (enrolling)
• The Second Hospital of Jiaxing — Jiaxing, Zhejiang, China (enrolling)
• The Second Hopsital of Hebei Medical University — Shijiazhuang, Hebei, China
• The First Affiliated Hopsital of Nanyang Medical College — Nanyang, Henan, China
• Henan Provincial People's Hospital — Zhengzhou, Henan, China
• Wuhan Hospital of Traditional Chinese and Western Medicine (Wuhan No.1 Hospital) — Wuhan, Hubei, China
• The Third Xiangya Hospital of Central South University — Changsha, Hunan, China
• Xiangya Hospital Central South University — Changsha, Hunan, China
• Chenzhou First People's Hospital — Chenzhou, Hunan, China
• Yueyang Central Hospital — Yueyang, Hunan, China
• Huai'an Second People's Hospital — Huai'an, Jiangsu, China
• Nanjing Brain Hospital — Nanjing, Jiangsu, China
• Affiliated Hospital of Nantong University — Nantong, Jiangsu, China
• Yangzhou First People's Hospital — Yangzhou, Jiangsu, China
• Inner Mongolia International Hospital of Mongolian Medicine — Hohhot, Neimenggu, China

Full record on ClinicalTrials.gov

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