TreatmentPhase 4NCT05430867
Efficacy and Safety of Memantine and Sodium Oligomannate in Patients With Moderate to Severe Alzheimer's Disease
A Phase 4 study testing Memantine Oral Tablet and GV-971 capsule in people with Treatment and Efficacy, 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. Memantine is recommended for the treatment of moderate and severe AD patients. Sodium oligomannate (GV-971) is a marine-derived oligosaccharide. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- What is being tested?
- Memantine Oral Tablet and GV-971 capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 31 Dec 2024
- Phase
- Phase 4
- 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
Who may be able to join
- age of 50-80 years old , either sex;
- met the diagnostic criteria for suspected AD;
- moderate to severe AD patients(5 points ≤Mini-Mental State Examination total score≤14 points);
- total Hachinski ischemic scale (HIS) score ≤4 points;
- memory loss for at least 12 months, with a progressive deterioration;
- brain 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 ;
- mental illness;
- unstable or severe heart, lung, liver, kidney, or hematopoietic diseases;
- uncorrectable visual and auditory disorders;
- simultaneous use of cholinesterase inhibitors, memantine or GV-971.
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. Memantine is recommended for the treatment of moderate and severe AD patients. 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. China Food and Drug Administration（CFDA）approved it for the treatment of mild to moderate AD in 2019. Due to the different mechanism of memantine and GV-971, theoretically, they may synergistically improve cognitive function and delay disease progression. However, there is a lack of data on their effectiveness and safety. Therefore, the purpose of this study is to compare the efficacy and safety of memantine and GV-971 monotherapy and combination therapy in patients with moderate to severe AD, which is of great significance for guiding the treatment of moderate and severe AD.
- Conditions
- Treatment, Efficacy, Safety, Alzheimer Disease
- Being tested
- Memantine Oral Tablet, GV-971 capsule
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Memantine Oral TabletDrug
Also called Memantine
Memantine 20mg once-daily
GV-971 capsuleDrug
Also called GV-971
GV-971 450mg twice a day
| Study group | Role | What they receive |
|---|---|---|
| Memantine monotherapy group | Experimental | Memantine 20mg once-daily Receives: Drug: Memantine Oral Tablet |
| GV-971 monotherapy group | Experimental | GV-971 450mg twice a day Receives: Drug: GV-971 capsule |
| Memantine combined with GV-971 group | Experimental | Memantine 20mg once-daily plus GV-971 450mg twice a day Receives: Drug: Memantine Oral Tablet; Drug: GV-971 capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive function
the change of Severe Impairment Battery score （The total score ranges from 0 to 100，higher scores mean a better outcome）from baseline at week 48
Measured: baseline, week 12, week 24, week 36,week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start1 Jul 2022 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TreatmentStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430867
- Sponsor's protocol ID
- XJTU1AF2022LSK-042
- Status last verified
- Jun 2022
- First submitted
- 20 Jun 2022
- Last updated
- 7 Jul 2022
- 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 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Memantine and Sodium Oligomannate in Patients With Moderate to Severe Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05430867
- Acronym / sponsor ID
- XJTU1AF2022LSK-042
- Conditions
- Treatment, Efficacy, Safety, Alzheimer Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 24 Jun 2022 (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. Memantine is recommended for the treatment of moderate and severe AD patients. 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. China Food and Drug Administration（CFDA）approved it for the treatment of mild to moderate AD in 2019. Due to the different mechanism of memantine and GV-971, theoretically, they may synergistically improve cognitive function and delay disease progression. However, there is a lack of data on their effectiveness and safety. Therefore, the purpose of this study is to compare the efficacy and safety of memantine and GV-971 monotherapy and combination therapy in patients with moderate to severe AD, which is of great significance for guiding the treatment of moderate and severe AD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Memantine monotherapy group | Experimental | Drug: Memantine Oral TabletMemantine 20mg once-daily |
| GV-971 monotherapy group | Experimental | Drug: GV-971 capsuleGV-971 450mg twice a day |
| Memantine combined with GV-971 group | Experimental | Drug: Memantine Oral Tablet, Drug: GV-971 capsuleMemantine 20mg once-daily plus GV-971 450mg twice a day |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- age of 50-80 years old , either sex;
- met the diagnostic criteria for suspected AD;
- moderate to severe AD patients(5 points ≤Mini-Mental State Examination total score≤14 points);
- total Hachinski ischemic scale (HIS) score ≤4 points;
- memory loss for at least 12 months, with a progressive deterioration;
Key exclusion criteria (5 listed)
- previous nervous system diseases ;
- mental illness;
- unstable or severe heart, lung, liver, kidney, or hematopoietic diseases;
- uncorrectable visual and auditory disorders;
- simultaneous use of cholinesterase inhibitors, memantine or GV-971.
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 |
|---|---|---|
| Memantine Oral TabletAlso: MemantineMemantine 20mg once-daily | Drug | Memantine combined with GV-971 group, Memantine monotherapy group |
| GV-971 capsuleAlso: GV-971GV-971 450mg twice a day | Drug | GV-971 monotherapy group, Memantine combined with GV-971 group |
Primary outcome
cognitive function
Time frame: baseline, week 12, week 24, week 36,week 48
the change of Severe Impairment Battery score （The total score ranges from 0 to 100，higher scores mean a better outcome）from baseline at week 48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
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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?
A Phase 4 study testing Memantine Oral Tablet and GV-971 capsule in people with Treatment and Efficacy, 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 7 Jul 2022. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (13572208524, 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,week 48). 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 7 Jul 2022.