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

Not yet recruiting

• Conditions: Alzheimer Disease
• Interventions: Drug: GV-971; Drug: Donepezil

• Registration Number: NCT05114499
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-11
• Study First Submitted: 2021-11-05
• Study First Submitted QC: 2021-11-05
• Last Update Submitted: 2021-11-05
• Study First Posted: 2021-11-10
• Last Update Posted: 2021-11-10
• Study Start: 2021-12
• Primary Completion: 2023-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GV-971 monotherapy group	GV-971	GV-971 450mg bid
Donepezil combined with GV-971 group	Donepezil	Donepezil 5mg qd+GV-971 450mg bid
Donepezil combined with GV-971 group	GV-971	Donepezil 5mg qd+GV-971 450mg bid
Donepezil monotherapy group	Donepezil	Donepezil 5mg qd

Primary Outcome Measures

Name	Time	Method
cognitive function	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