Efficacy and Safety of Memantine and Sodium Oligomannate in Patients With Moderate to Severe Alzheimer's Disease

Phase 4

Not yet recruiting

• Conditions: Safety; Treatment; Efficacy; Alzheimer Disease
• Interventions: Drug: Memantine Oral Tablet; Drug: GV-971 capsule

• Registration Number: NCT05430867
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief Summary

Alzheimer's disease (AD) is the main cause of dementia. At present, AD is incurable. Memantine is recommended for the treatment of moderate and severe AD patients. Sodium oligomannate (GV-971) is a marine-derived oligosaccharide. It is proposed that it can reconstitute the gut microbiota, and inhibit neuroinflammation in the brain as observed in animal models. It reduces Aβ deposition in the brain of Aβ-transgenic mice. The reduction in both Aβ deposition and neuroinflammation may synergistically contribute to the improvement of cognitive impairment and delay the progress of the disease. China Food and Drug Administration（CFDA）approved it for the treatment of mild to moderate AD in 2019. Due to the different mechanism of memantine and GV-971, theoretically, they may synergistically improve cognitive function and delay disease progression. However, there is a lack of data on their effectiveness and safety. Therefore, the purpose of this study is to compare the efficacy and safety of memantine and GV-971 monotherapy and combination therapy in patients with moderate to severe AD, which is of great significance for guiding the treatment of moderate and severe AD.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-06-20
• Study First Submitted QC: 2022-06-20
• Study First Posted: 2022-06-24
• Study Start: 2022-07-01
• Last Update Submitted: 2022-07-03
• Last Update Posted: 2022-07-07
• Primary Completion: 2024-07-01
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• age of 50-80 years old , either sex;
• met the diagnostic criteria for suspected AD;
• moderate to severe AD patients(5 points ≤Mini-Mental State Examination total score≤14 points);
• total Hachinski ischemic scale (HIS) score ≤4 points;
• memory loss for at least 12 months, with a progressive deterioration;
• brain MRI scan suggesting a significant possibility of AD;
• no obvious physical signs during nervous system examination;
• stable and reliable caregivers;
• elementary school or higher education level;
• signed an informed consent form.

Exclusion Criteria

• previous nervous system diseases ;
• mental illness;
• unstable or severe heart, lung, liver, kidney, or hematopoietic diseases;
• uncorrectable visual and auditory disorders;
• simultaneous use of cholinesterase inhibitors, memantine or GV-971.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Memantine combined with GV-971 group	Memantine Oral Tablet	Memantine 20mg once-daily plus GV-971 450mg twice a day
Memantine combined with GV-971 group	GV-971 capsule	Memantine 20mg once-daily plus GV-971 450mg twice a day
GV-971 monotherapy group	GV-971 capsule	GV-971 450mg twice a day
Memantine monotherapy group	Memantine Oral Tablet	Memantine 20mg once-daily

Primary Outcome Measures

Name	Time	Method
cognitive function	baseline, week 12, week 24, week 36,week 48	the change of Severe Impairment Battery score （The total score ranges from 0 to 100，higher scores mean a better outcome）from baseline at week 48