Status:
UNKNOWN
Efficacy and Safety of Memantine and Sodium Oligomannate in Patients With Moderate to Severe Alzheimer's Disease
Lead Sponsor:
First Affiliated Hospital Xi'an Jiaotong University
Conditions:
Treatment
Efficacy
Eligibility:
All Genders
50-80 years
Phase:
PHASE4
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 ma...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05430867
Start Date
July 1 2022
End Date
December 31 2024
Last Update
July 7 2022
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