Efficacy and Safety of Memantine and Sodium Oligomannate in Patients With Moderate to Severe Alzheimer's Disease
Primary Purpose
Treatment, Efficacy, Safety
Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Memantine Oral Tablet
GV-971 capsule
Sponsored by
About this trial
This is an interventional treatment trial for Treatment
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Memantine monotherapy group
GV-971 monotherapy group
Memantine combined with GV-971 group
Arm Description
Memantine 20mg once-daily
GV-971 450mg twice a day
Memantine 20mg once-daily plus GV-971 450mg twice a day
Outcomes
Primary Outcome Measures
cognitive function
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05430867
First Posted
June 20, 2022
Last Updated
July 3, 2022
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
1. Study Identification
Unique Protocol Identification Number
NCT05430867
Brief Title
Efficacy and Safety of Memantine and Sodium Oligomannate in Patients With Moderate to Severe Alzheimer's Disease
Official Title
Efficacy and Safety of Memantine and Sodium Oligomannate in Patients With Moderate to Severe Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2022 (Anticipated)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment, Efficacy, Safety, Alzheimer Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Memantine monotherapy group
Arm Type
Experimental
Arm Description
Memantine 20mg once-daily
Arm Title
GV-971 monotherapy group
Arm Type
Experimental
Arm Description
GV-971 450mg twice a day
Arm Title
Memantine combined with GV-971 group
Arm Type
Experimental
Arm Description
Memantine 20mg once-daily plus GV-971 450mg twice a day
Intervention Type
Drug
Intervention Name(s)
Memantine Oral Tablet
Other Intervention Name(s)
Memantine
Intervention Description
Memantine 20mg once-daily
Intervention Type
Drug
Intervention Name(s)
GV-971 capsule
Other Intervention Name(s)
GV-971
Intervention Description
GV-971 450mg twice a day
Primary Outcome Measure Information:
Title
cognitive function
Description
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
Time Frame
baseline, week 12, week 24, week 36,week 48
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jin Wang
Phone
13572208524
Email
drwangjin@163.com
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Memantine and Sodium Oligomannate in Patients With Moderate to Severe Alzheimer's Disease
We'll reach out to this number within 24 hrs