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

• Status: Not yet recruiting
• Trial end date: 2029-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Green Valley (Shanghai) Pharmaceuticals Co., Ltd.

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.