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

Sponsor
First Affiliated Hospital Xi'an Jiaotong University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05430867
Collaborator
(none)
150
Enrollment
3
Arms
30
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Memantine Oral Tablet
  • Drug: GV-971 capsule
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Memantine and Sodium Oligomannate in Patients With Moderate to Severe Alzheimer's Disease
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Memantine monotherapy group

Memantine 20mg once-daily

Drug: Memantine Oral Tablet
Memantine 20mg once-daily
Other Names:
  • Memantine

    		•
    Experimental: GV-971 monotherapy group

    GV-971 450mg twice a day

    Drug: GV-971 capsule
    GV-971 450mg twice a day
    Other Names:
  • GV-971

    		•
    Experimental: Memantine combined with GV-971 group

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

    Drug: Memantine Oral Tablet
    Memantine 20mg once-daily
    Other Names:
  • Memantine

    • Drug: GV-971 capsule
    GV-971 450mg twice a day
    Other Names:
  • GV-971

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • First Affiliated Hospital Xi'an Jiaotong University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    First Affiliated Hospital Xi'an Jiaotong University
    ClinicalTrials.gov Identifier:
    NCT05430867
    Other Study ID Numbers:
    • XJTU1AF2022LSK-042
    First Posted:
    Jun 24, 2022
    Last Update Posted:
    Jul 7, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Alzheimer Disease
    Memantine

    Study Results

    No Results Posted as of Jul 7, 2022