An observational study in Alzheimer Disease, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Status unknown. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-11-10.
Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Observational
Alzheimer's disease (AD) is the main cause of dementia. At present, AD is incurable. Cholinesterase inhibitors, especially donepezil, are the first choice for mild and moderate AD. 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. The State Food and Drug Administration of China (SFDA) approved it for the treatment of mild to moderate AD in 2019. Due to the different mechanism of cholinesterase inhibitor and GV-971, theoretically, they may synergistically improve cognitive function and delay disease progression. They are also used in patients with AD, but there is a lack of data on their effectiveness and safety. Therefore, the purpose of this observational study is to compare the efficacy and safety of donepezil and GV-971 monotherapy and combination therapy in patients with mild and moderate AD, which is of great significance for guiding the treatment of mild and moderate AD.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's planned enrollment of 150 is below the median of 200 across 751 observational studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 306 studies on the registry; 86 are open to participants now.
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The patients will be enrolled from our memory clinic and in-patients and should meet the the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) (1984) criteria for probable AD.The diagnosis of AD is mainly based on detail clinical history from caregivers, neuropsychological testing, and brain MRI.
Exclusion Criteria:
Donepezil 5mg qd
Drug: Donepezil
GV-971 450mg bid
Drug: GV-971
Donepezil 5mg qd+GV-971 450mg bid
Drug: Donepezil · Drug: GV-971
Donepezil 5mg qd
GV-971 450mg bid
cognitive function
the change of Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-cog) score from baseline at week 36
Time frame: baseline, week 12, week 24, week 36
No study locations are listed for this record.
This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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First Affiliated Hospital Xi'an Jiaotong University