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

July 3, 2022 updated by: First Affiliated Hospital Xi'an Jiaotong University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cognitive function
Time Frame: 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
baseline, week 12, week 24, week 36,week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2022

Primary Completion (Anticipated)

July 1, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

June 20, 2022

First Submitted That Met QC Criteria

June 20, 2022

First Posted (Actual)

June 24, 2022

Study Record Updates

Last Update Posted (Actual)

July 7, 2022

Last Update Submitted That Met QC Criteria

July 3, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF2022LSK-042

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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