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

Xi'an Jiaotong University

Status and phase: Not yet enrolling; Phase 4

Conditions: Alzheimer Disease; Treatment; Efficacy; Safety

Treatments: Drug: GV-971 capsule; Drug: Memantine Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT05430867

XJTU1AF2022LSK-042

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Memantine monotherapy group

Experimental group

Description:

Memantine 20mg once-daily

Treatment:

Drug: Memantine Oral Tablet

GV-971 monotherapy group

Experimental group

Description:

GV-971 450mg twice a day

Treatment:

Drug: GV-971 capsule

Memantine combined with GV-971 group

Experimental group

Description:

Memantine 20mg once-daily plus GV-971 450mg twice a day

Treatment:

Drug: Memantine Oral Tablet

Drug: GV-971 capsule