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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Memantine 20mg once-daily
GV-971 450mg twice a day
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
Time frame: baseline, week 12, week 24, week 36,week 48
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.