NCT05430867

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2022

Typical duration for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 24, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

July 7, 2022

Status Verified

June 1, 2022

Enrollment Period

2 years

First QC Date

June 20, 2022

Last Update Submit

July 3, 2022

Conditions

TreatmentEfficacySafetyAlzheimer Disease

Outcome Measures

Primary Outcomes (1)

  • 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

    baseline, week 12, week 24, week 36,week 48

Study Arms (3)

Memantine monotherapy group

EXPERIMENTAL

Memantine 20mg once-daily

Drug: Memantine Oral Tablet

GV-971 monotherapy group

EXPERIMENTAL

GV-971 450mg twice a day

Drug: GV-971 capsule

Memantine combined with GV-971 group

EXPERIMENTAL

Memantine 20mg once-daily plus GV-971 450mg twice a day

Drug: Memantine Oral TabletDrug: GV-971 capsule

Interventions

Memantine Oral TabletDRUG

Memantine 20mg once-daily

Also known as: Memantine
Memantine combined with GV-971 groupMemantine monotherapy group
GV-971 capsuleDRUG

GV-971 450mg twice a day

Also known as: GV-971
GV-971 monotherapy groupMemantine combined with GV-971 group

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • no obvious physical signs during nervous system examination;
  • stable and reliable caregivers;
  • elementary school or higher education level;
  • signed an informed consent form.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alzheimer Disease

Interventions

MemantineGV-971

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AmantadineAdamantaneBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Central Study Contacts

Jin Wang

CONTACT

13572208524drwangjin@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2022

First Posted

June 24, 2022

Study Start

July 1, 2022

Primary Completion

July 1, 2024

Study Completion

December 31, 2024

Last Updated

July 7, 2022

Record last verified: 2022-06