Alzheimer DiseaseNCT05114499
Efficacy and Safety of Donepezil and Sodium Oligomannate in Patients With Mild to Moderate Alzheimer's Disease
An observational study of Alzheimer Disease, run by First Affiliated Hospital Xi'an Jiaotong University.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Donepezil and GV-971
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Dec 2021to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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 ;
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- no obvious physical signs during nervous system examination;
- stable and reliable caregivers,
- elementary school or higher education level
- signed an informed consent form
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
- Being tested
- Donepezil, GV-971
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DonepezilDrug
Donepezil 5mg qd
GV-971Drug
GV-971 450mg bid
| Study group | Role | What they receive |
|---|---|---|
| Donepezil monotherapy group | Donepezil 5mg qd Receives: Drug: Donepezil | |
| GV-971 monotherapy group | GV-971 450mg bid Receives: Drug: GV-971 | |
| Donepezil combined with GV-971 group | Donepezil 5mg qd+GV-971 450mg bid Receives: Drug: Donepezil; Drug: GV-971 |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive function
the change of Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-cog) score from baseline at week 36
Measured: baseline, week 12, week 24, week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study startDec 2021 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05114499
- Sponsor's protocol ID
- XJTU1AF2021LSK-328
- Status last verified
- Nov 2021
- First submitted
- 5 Nov 2021
- Last updated
- 10 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Donepezil and Sodium Oligomannate in Patients With Mild to Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05114499
- Acronym / sponsor ID
- XJTU1AF2021LSK-328
- Conditions
- Alzheimer Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- Dec 2021 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 10 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Donepezil monotherapy group | – | Drug: DonepezilDonepezil 5mg qd |
| GV-971 monotherapy group | – | Drug: GV-971GV-971 450mg bid |
| Donepezil combined with GV-971 group | – | Drug: Donepezil, Drug: GV-971Donepezil 5mg qd+GV-971 450mg bid |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DonepezilDonepezil 5mg qd | Drug | Donepezil combined with GV-971 group, Donepezil monotherapy group |
| GV-971GV-971 450mg bid | Drug | Donepezil combined with GV-971 group, GV-971 monotherapy group |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by First Affiliated Hospital Xi'an Jiaotong University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin Wang, doctor (+86 29 85324033, drwangjin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cognitive function (time frame: baseline, week 12, week 24, week 36). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2021.