Efficacy and Safety of Donepezil and Sodium Oligomannate in Patients With Mild to Moderate Alzheimer's Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 150
- Primary Endpoint
- cognitive function
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 50 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Donepezil monotherapy group
Donepezil 5mg qd
Intervention: Donepezil (Drug)
GV-971 monotherapy group
GV-971 450mg bid
Intervention: GV-971 (Drug)
Donepezil combined with GV-971 group
Donepezil 5mg qd+GV-971 450mg bid
Intervention: Donepezil (Drug)
Donepezil combined with GV-971 group
Donepezil 5mg qd+GV-971 450mg bid
Intervention: GV-971 (Drug)
Outcomes
Primary Outcomes
cognitive function
Time Frame: baseline, week 12, week 24, week 36
the change of Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-cog) score from baseline at week 36
Secondary Outcomes
No secondary outcomes reported