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

November 5, 2021 updated by: First Affiliated Hospital Xi'an Jiaotong University
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The patients will be enrolled from our memory clinic and in-patients and should meet the the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) (1984) criteria for probable AD.The diagnosis of AD is mainly based on detail clinical history from caregivers, neuropsychological testing, and brain MRI.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Donepezil monotherapy group
Donepezil 5mg qd
Drug: Donepezil
Donepezil 5mg qd
GV-971 monotherapy group
GV-971 450mg bid
Drug: GV-971
GV-971 450mg bid
Donepezil combined with GV-971 group
Donepezil 5mg qd+GV-971 450mg bid
Drug: Donepezil
Donepezil 5mg qd
Drug: GV-971
GV-971 450mg bid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline, week 12, week 24, week 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2021

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

November 5, 2021

First Submitted That Met QC Criteria

November 5, 2021

First Posted (Actual)

November 10, 2021

Study Record Updates

Last Update Posted (Actual)

November 10, 2021

Last Update Submitted That Met QC Criteria

November 5, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF2021LSK-328

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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