Register a trial

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
Nebraska
Country [12] 0 0
United States of America
State/province [12] 0 0
Nevada
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oregon
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Utah
Country [22] 0 0
United States of America
State/province [22] 0 0
Virginia
Country [23] 0 0
United States of America
State/province [23] 0 0
Washington
Country [24] 0 0
Canada
State/province [24] 0 0
Alberta
Country [25] 0 0
Canada
State/province [25] 0 0
British Columbia
Country [26] 0 0
Canada
State/province [26] 0 0
Nova Scotia
Country [27] 0 0
Canada
State/province [27] 0 0
Ontario
Country [28] 0 0
Canada
State/province [28] 0 0
Quebec
Country [29] 0 0
China
State/province [29] 0 0
Anhui
Country [30] 0 0
China
State/province [30] 0 0
Beijing
Country [31] 0 0
China
State/province [31] 0 0
Chongqing
Country [32] 0 0
China
State/province [32] 0 0
Fujian
Country [33] 0 0
China
State/province [33] 0 0
Guangdong
Country [34] 0 0
China
State/province [34] 0 0
Hebei
Country [35] 0 0
China
State/province [35] 0 0
Hunan
Country [36] 0 0
China
State/province [36] 0 0
Jiangsu
Country [37] 0 0
China
State/province [37] 0 0
Jiangxi
Country [38] 0 0
China
State/province [38] 0 0
Jilin
Country [39] 0 0
China
State/province [39] 0 0
Ningxia Hui Autonomous Region
Country [40] 0 0
China
State/province [40] 0 0
Shaanxi
Country [41] 0 0
China
State/province [41] 0 0
Shandong
Country [42] 0 0
China
State/province [42] 0 0
Shanghai
Country [43] 0 0
China
State/province [43] 0 0
Shanxi
Country [44] 0 0
China
State/province [44] 0 0
Sichuan
Country [45] 0 0
China
State/province [45] 0 0
Tianjin
Country [46] 0 0
China
State/province [46] 0 0
Yunnan
Country [47] 0 0
China
State/province [47] 0 0
Zhejiang
Country [48] 0 0
Czechia
State/province [48] 0 0
Hradec Králové
Country [49] 0 0
Czechia
State/province [49] 0 0
Kladno
Country [50] 0 0
Czechia
State/province [50] 0 0
Kutná Hora
Country [51] 0 0
Czechia
State/province [51] 0 0
Praha 10
Country [52] 0 0
Czechia
State/province [52] 0 0
Praha
Country [53] 0 0
France
State/province [53] 0 0
Bas Rhin
Country [54] 0 0
France
State/province [54] 0 0
Bouches-du-Rhône
Country [55] 0 0
France
State/province [55] 0 0
Cedex 5
Country [56] 0 0
France
State/province [56] 0 0
De Lattre De Tassigny
Country [57] 0 0
France
State/province [57] 0 0
Gironde
Country [58] 0 0
France
State/province [58] 0 0
Grand Est
Country [59] 0 0
France
State/province [59] 0 0
Haute Garonne
Country [60] 0 0
France
State/province [60] 0 0
Ille Et Vilaine
Country [61] 0 0
France
State/province [61] 0 0
Indre Et Loire
Country [62] 0 0
France
State/province [62] 0 0
Loire Atlantique
Country [63] 0 0
France
State/province [63] 0 0
Marne
Country [64] 0 0
France
State/province [64] 0 0
Rhone
Country [65] 0 0
France
State/province [65] 0 0
Paris
Country [66] 0 0
Hong Kong
State/province [66] 0 0
Shatin
Country [67] 0 0
Netherlands
State/province [67] 0 0
Van Der Boechorststraat 6
Country [68] 0 0
Netherlands
State/province [68] 0 0
Breda
Country [69] 0 0
Netherlands
State/province [69] 0 0
Herzogenbusch
Country [70] 0 0
Netherlands
State/province [70] 0 0
Zwolle
Country [71] 0 0
Poland
State/province [71] 0 0
Bialystok
Country [72] 0 0
Poland
State/province [72] 0 0
Bydgoszcz
Country [73] 0 0
Poland
State/province [73] 0 0
Katowice
Country [74] 0 0
Poland
State/province [74] 0 0
Kraków
Country [75] 0 0
Poland
State/province [75] 0 0
Lublin
Country [76] 0 0
Poland
State/province [76] 0 0
Oswiecim
Country [77] 0 0
Poland
State/province [77] 0 0
Poznan
Country [78] 0 0
Poland
State/province [78] 0 0
Warszawa
Country [79] 0 0
Poland
State/province [79] 0 0
Wroclaw
Country [80] 0 0
Poland
State/province [80] 0 0
Zabrze
Country [81] 0 0
Taiwan
State/province [81] 0 0
Taipei
Country [82] 0 0
Taiwan
State/province [82] 0 0
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