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

NCT ID: NCT05114499

Last Updated: 2021-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-31

Study Completion Date

2024-12-31

Brief Summary

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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

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Conditions

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Alzheimer Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Donepezil monotherapy group

Donepezil 5mg qd

Donepezil

Intervention Type DRUG

Donepezil 5mg qd

GV-971 monotherapy group

GV-971 450mg bid

GV-971

Intervention Type DRUG

GV-971 450mg bid

Donepezil combined with GV-971 group

Donepezil 5mg qd+GV-971 450mg bid

Donepezil

Intervention Type DRUG

Donepezil 5mg qd

GV-971

Intervention Type DRUG

GV-971 450mg bid

Interventions

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Donepezil

Donepezil 5mg qd

Intervention Type DRUG

GV-971

GV-971 450mg bid

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Jin Wang, doctor

Role: CONTACT

Phone: +86 29 85324033

Email: [email protected]

Other Identifiers

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XJTU1AF2021LSK-328

Identifier Type: -

Identifier Source: org_study_id