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

RecruitingPhase 4Ages 50 Years - 85 YearsAllGreen Valley (Shanghai) Pharmaceuticals Co., Ltd.
NCT05908695 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • GV-971
  • Placebo
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Where

50 sites
Huainan First People's Hospital
Huainan, China
Beijing Anding Hospital, Capital Medical University
Beijing, China
Beijing Anzhen Hospital, Capital Medical University
Beijing, China
Beijing Hospital
Beijing, China
Beijing Tongren Hospital, Capital Medical University
Beijing, China
Peking University Shougang Hospital
Beijing, China
The First Medical Center, Chinese PLA General Hospital
Beijing, China
Xuanwu Hospital, Capital Medical University
Beijing, China

…and 42 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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