Efficacy and Safety of Donepezil and Sodium Oligomannate in Patients With Mild to Moderate Alzheimer's Disease

Xi'an Jiaotong University

Status

Not yet enrolling

Conditions

Alzheimer Disease

Treatments

Drug: Donepezil

Drug: GV-971

Study type

Observational

Funder types

Other

Identifiers

NCT05114499

XJTU1AF2021LSK-328

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

age of 50-85 years old , either sex;
met the diagnostic criteria for suspected AD;
mild to moderate AD patients, that is, patients with 11 points ≤Mini-Mental State Examination(MMSE) total score ≤26 points
total Hachinski ischemic scale (HIS) score ≤4 points;
memory loss for at least 12 months, with a tendency of progressive deterioration;
brain magnetic resonance imaging（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 (including stroke, optic neuromyelitis, Parkinson's disease, epilepsy, etc.);
mental illness according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition（DSM-IV), Text Revision criteria, including schizophrenia and other mental illness, bipolar disorder, and severe depression or paralysis;
unstable or severe heart, lung, liver, kidney, or hematopoietic diseases;
uncorrectable visual and auditory disorders that affected completing neuropsychological tests and scale assessments;
simultaneous use of cholinesterase inhibitors or memantine.