A Study of Sodium Oligomannate (GV-971) in Participants With Mild to Moderate Alzheimer's Disease (GREEN MEMORY)

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ClinicalTrials.gov Identifier: NCT04520412

Recruitment Status : Suspended (The quality of study was seriously affected by the COVID-19, so it was decided to suspend the trial and restart it at the right time.)

First Posted : August 20, 2020

Last Update Posted : November 23, 2022

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Green Valley (Shanghai) Pharmaceuticals Co., Ltd.

Tracking Information

First Submitted Date ^ICMJE

August 11, 2020

First Posted Date ^ICMJE

August 20, 2020

Last Update Posted Date

November 23, 2022

Actual Study Start Date ^ICMJE

October 27, 2020

Estimated Primary Completion Date

December 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change from baseline in the ADAS-cog/11 score [ Time Frame: Baseline, 48 weeks and 52 weeks ]
Change from baseline in Alzheimer's Disease Assessments Scale - cognitive (ADAS-cog/11) scale total score. The total score of ADAS-cog/11 is 0-70, with higher scores mean a worse outcome.
Change from baseline in the ADCS-CGIC score [ Time Frame: Baseline, 48 weeks and 52 weeks ]
Change from baseline on Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) scale total score. The total score of ADCS-CGIC is 1-7, with higher scores mean a worse outcome.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

Change from baseline in NPI score [ Time Frame: Baseline, 36 Weeks, 52 Weeks ]
Change from baseline in Neuropsychiatric Inventory (NPI) score. The total score of NPI is 0-144, with higher scores mean a worse outcome.
Change from baseline in MMSE score [ Time Frame: Baseline, 52 Weeks ]
Change from baseline in Mini Mental State Examination (MMSE) score. The total score of MMSE is 0-30, with higher scores mean a better outcome.
Change from baseline in ADCS-ADL23 score [ Time Frame: Baseline, 36 Weeks, 52 Weeks ]
Change from baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living; 23-item Scale (ADCS-ADL23) score. The total score of ADCS-ADL23 is 0-78, with higher scores mean a better outcome.
Change from baseline in NPI caregiver items [ Time Frame: Baseline, 52 Weeks ]
Change from baseline in Neuropsychiatric Inventory (NPI) caregiver items . The total score of NPI caregiver items is 0-60, with higher scores mean a worse outcome.
Change from baseline in ZBI score [ Time Frame: Baseline, 52 Weeks ]
Change from baseline in Zarit Burden Interview (ZBI) score. The total score of ZBI is 0-88, with higher scores mean a worse outcome.
Assess the efficacy of GV-971 throughout the OLE period [ Time Frame: Baseline, 52 Weeks, 78 Weeks ]
Change from baseline in Alzheimer's Disease Assessments Scale - cognitive (ADAS-cog/11) scale total score. The total score of ADAS-cog/11 is 0-70, with higher scores mean a worse outcome.
Assess the efficacy of GV-971 throughout the OLE period [ Time Frame: Baseline, 52 Weeks, 78 Weeks ]
Change from baseline on Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) scale total score. The total score of ADCS-CGIC is 1-7, with higher scores mean a worse outcome.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Pre-specified Outcome Measures

Evaluate the population PK [ Time Frame: Baseline, 12 Weeks, 24 Weeks, 52 Weeks ]
Determine serum levels of GV-971 in population PK
Evaluate the effect of GV-971 on brain structure neurodegeneration [ Time Frame: Baseline, 52 Weeks ]
Changes from baseline in volumetric magnetic resonance imaging (MRI)

Original Other Pre-specified Outcome Measures

Same as current

Descriptive Information

Brief Title ^ICMJE

A Study of Sodium Oligomannate (GV-971) in Participants With Mild to Moderate Alzheimer's Disease

Official Title ^ICMJE

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)

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Alzheimer Disease

Intervention ^ICMJE

Drug: GV-971
Administered PO
Drug: Placebo
Administered PO

Study Arms ^ICMJE

Experimental: GV-971
Intervention: Drug: GV-971
Placebo Comparator: Placebo
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Suspended

Estimated Enrollment ^ICMJE

2046

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date ^ICMJE

October 2026

Estimated Primary Completion Date

December 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

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.

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

50 Years to 85 Years (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Australia, Canada, China, Czechia, France, Hong Kong, Netherlands, Poland, Taiwan, United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT04520412

Other Study ID Numbers ^ICMJE

GV971-007

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement ^ICMJE

Plan to Share IPD:

Undecided

Current Responsible Party

Green Valley (Shanghai) Pharmaceuticals Co., Ltd.

Original Responsible Party

Shanghai Greenvalley Pharmaceutical Co., Ltd.

Current Study Sponsor ^ICMJE

Green Valley (Shanghai) Pharmaceuticals Co., Ltd.

Original Study Sponsor ^ICMJE

Shanghai Greenvalley Pharmaceutical Co., Ltd.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Study Director, Ph D

Green Valley (Shanghai) Pharmaceuticals Co., Ltd.

PRS Account

Green Valley (Shanghai) Pharmaceuticals Co., Ltd.

Verification Date

November 2022

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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