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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04520412




Registration number
NCT04520412
Ethics application status
Date submitted
11/08/2020
Date registered
20/08/2020

Titles & IDs
Public title
A Study of Sodium Oligomannate (GV-971) in Participants With Mild to Moderate Alzheimer's Disease
Scientific title
A Phase 3, Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Sodium Oligomannate (GV-971) in Treatment of Mild to Moderate Alzheimer's Disease (GREEN MEMORY: GREen Valley 971 EvaluatioN Memory)
Secondary ID [1] 0 0
GV971-007
Universal Trial Number (UTN)
Trial acronym
GREEN MEMORY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GV-971
Treatment: Drugs - Placebo

Experimental: GV-971 -

Placebo comparator: Placebo -


Treatment: Drugs: GV-971
Administered PO

Treatment: Drugs: Placebo
Administered PO
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in the ADAS-cog/11 score
Timepoint [1] 0 0
Baseline, 48 weeks and 52 weeks
Primary outcome [2] 0 0
Change from baseline in the ADCS-CGIC score
Timepoint [2] 0 0
Baseline, 48 weeks and 52 weeks
Secondary outcome [1] 0 0
Change from baseline in NPI score
Timepoint [1] 0 0
Baseline, 36 Weeks, 52 Weeks
Secondary outcome [2] 0 0
Change from baseline in MMSE score
Timepoint [2] 0 0
Baseline, 52 Weeks
Secondary outcome [3] 0 0
Change from baseline in ADCS-ADL23 score
Timepoint [3] 0 0
Baseline, 36 Weeks, 52 Weeks
Secondary outcome [4] 0 0
Change from baseline in NPI caregiver items
Timepoint [4] 0 0
Baseline, 52 Weeks
Secondary outcome [5] 0 0
Change from baseline in ZBI score
Timepoint [5] 0 0
Baseline, 52 Weeks
Secondary outcome [6] 0 0
Assess the efficacy of GV-971 throughout the OLE period
Timepoint [6] 0 0
Baseline, 52 Weeks, 78 Weeks
Secondary outcome [7] 0 0
Assess the efficacy of GV-971 throughout the OLE period
Timepoint [7] 0 0
Baseline, 52 Weeks, 78 Weeks

Eligibility
Key inclusion criteria
* Mild to moderate AD per NIA-AA.
* History of cognitive and functional decline over at least 1 year.
* MMSE scores between 11 and 24 (inclusive) at baseline.
* Brain MRI scan show the highest possibility of AD.
* Have a study partner/caregiver.
Minimum age
50 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Diagnosis of a dementia-related central nervous system disease other than AD.
* Major structural brain disease as judged by MRI.
* A resting heart rate of < 50 beats per minute (bpm) after 5 minutes of rest in sitting or supine position.
* Major medical illness or unstable medical condition within 6 months of screening.
* Concomitant use of AChEIs and/or memantine within 30 days before first MMSE score, and during the study.
* Inadequate hepatic function.
* Inadequate organ and marrow function.
* ECG clinically significant abnormalities.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Suspended
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2026
Actual
Sample size
Target
2046
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Hornsby Ku-ring-gai Hospital - Hornsby
Recruitment hospital [2] 0 0
KaRa MINDS - Macquarie Park
Recruitment hospital [3] 0 0
Austin Health - Heidelberg Repatriation Hospital - Melbourne
Recruitment hospital [4] 0 0
Alzheimer's Research Foundation - Nedlands
Recruitment postcode(s) [1] 0 0
2077 - Hornsby
Recruitment postcode(s) [2] 0 0
2113 - Macquarie Park
Recruitment postcode(s) [3] 0 0
3081 - Melbourne
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
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Arizona
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California
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Florida
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Georgia
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Illinois
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Indiana
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Kansas
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Massachusetts
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Michigan
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Missouri
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Taipei
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Taoyuan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director, Ph D
Address 0 0
Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04520412