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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04520412




Registration number
NCT04520412
Ethics application status
Date submitted
11/08/2020
Date registered
20/08/2020
Date last updated
23/11/2022

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
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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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Missouri
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Nebraska
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Nevada
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New Jersey
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New York
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North Carolina
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Ohio
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Oregon
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Utah
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Washington
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Alberta
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British Columbia
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Zhejiang
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Hradec Králové
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Zwolle
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Taiwan
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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
The purpose of this study is to evaluate the safety, tolerability and efficacy of GV-971 in
mild to moderate Alzheimer's disease.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04520412
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04520412