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

NCT ID: NCT05430867

Last Updated: 2022-07-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2024-12-31

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.

Conditions

Treatment; Efficacy; Safety; Alzheimer Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Memantine monotherapy group

Memantine 20mg once-daily

Group Type: EXPERIMENTAL

Memantine Oral Tablet

Intervention Type: DRUG

Memantine 20mg once-daily

GV-971 monotherapy group

GV-971 450mg twice a day

Group Type: EXPERIMENTAL

GV-971 capsule

Intervention Type: DRUG

GV-971 450mg twice a day

Memantine combined with GV-971 group

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

Group Type: EXPERIMENTAL

Memantine Oral Tablet

Intervention Type: DRUG

Memantine 20mg once-daily

GV-971 capsule

Intervention Type: DRUG

GV-971 450mg twice a day

Interventions

Memantine Oral Tablet

Memantine 20mg once-daily

Intervention Type: DRUG

GV-971 capsule

GV-971 450mg twice a day

Intervention Type: DRUG

Other Intervention Names

Memantine; GV-971

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Jin Wang

Role: CONTACT

drwangjin@163.com

13572208524

Other Identifiers

XJTU1AF2022LSK-042

Identifier Type: -

Identifier Source: org_study_id