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

NCT05114499 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2021-11-10

No results posted yet for this study

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.

Conditions

  • Alzheimer Disease

Interventions

DRUG

Donepezil

Donepezil 5mg qd

DRUG

GV-971

GV-971 450mg bid

Sponsors & Collaborators

  • First Affiliated Hospital Xi'an Jiaotong University

    lead OTHER

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-31
Primary Completion
2023-12-31
Completion
2024-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05114499 on ClinicalTrials.gov