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An Efficacy and Safety Study of Sodium Oligomannate (GV-971) for the Treatment of Alzheimer's Disease

Primary Purpose

Alzheimer's Disease

Status
Not yet recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
GV-971
Placebo
Sponsored by
Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. Hachinski Ischemic Score (HIS) scale total score ≤ 4. Hamilton Rating Scale for Depression/17 items (HAMD) total score ≤ 10. Brain MRI scan show the highest possibility of AD. Have a reliable study partner/caregiver. Sign the informed consent form. 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 10 minutes of rest. Major medical illness or unstable medical condition within 12 months of screening. Concomitant use of donepezil, rivastigmine, galanthamine, huperzine A, memantine, or aducanumab within 6 moinths prior to baseline. Inadequate hepatic function. Inadequate organ function. ECG clinically significant abnormalities.

Sites / Locations

  • Beijing Anding Hospital, Capital Medical University
  • Beijing Hospital
  • Xuanwu Hospital, Capital Medical University
  • The First Affiliated Hopsital of Xiamen University
  • The First Affiliated Hopsital of Guangzhou Medical University
  • The Second Affiliated Hopsital of Guangzhou Medical University
  • The First People's Hospital of Nanning
  • Shijiazhuang People's Hospital
  • The First Hospital of Hebei Medical University
  • The Second Hopsital of Hebei Medical University
  • Tangshan Workers' Hospital
  • The First Affiliated Hopsital of Nanyang Medical College
  • Henan Provincial People's Hospital
  • Chenzhou First People's Hospital
  • Yueyang Central Hospital
  • Huai'an Second People's Hospital
  • Nanjing Brain Hospital
  • Affiliated Hospital of Nantong University
  • The Affiliated Hospital of Xuzhou Medical University
  • Yangzhou First People's Hospital
  • Jiujiang University Affiliated Hospital
  • The Second Affiliated Hopsital of Nanchang University
  • The First Bethune Hospital of Jilin University
  • Qilu Hospital of Shandong University
  • Shandong Provincial Hospital
  • Yantai Yuhuangding Hospital
  • Tianjin People's Hospital
  • The Second Hospital of Jiaxing

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GV-971

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in the ADAS-cog/12 score
Change from baseline in Alzheimer's Disease Assessments Scale - cognitive (ADAS-cog/12) scale total score. The total score of ADAS-cog/12 is 0-75, with higher scores mean a worse outcome.
Change from baseline in ADCS-ADL23 score
Change from baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living-23-item Scale (ADCS-ADL23) score in moderate AD participants. The total score of ADCS-ADL23 is 0-78, with higher scores mean a better outcome.

Secondary Outcome Measures

Change from baseline in MMSE score
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 the CIBIC-Plus score
Change from baseline on Clinician's Interview-Based Impression of Change Plus (CIBIC-Plus) scale total score. The total score of CIBIC-Plus is 1-7, with higher scores mean a worse outcome.
Change from baseline in NPI score
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 ADCS-ADL23 score
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.

Full Information

First Posted
May 31, 2023
Last Updated
June 8, 2023
Sponsor
Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05908695
Brief Title
An Efficacy and Safety Study of Sodium Oligomannate (GV-971) for the Treatment of Alzheimer's Disease
Official Title
A 36-week, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Evaluate the Efficacy and Safety of Sodium Oligomannate (GV-971) in Treatment of Mild to Moderate Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
June 2029 (Anticipated)
Study Completion Date
December 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Green Valley (Shanghai) Pharmaceuticals Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary purpose of this study is to confirm the clinical efficacy and mechanism of action of GV-971, and identify incidence of known adverse reactions in long-term use and observe new adverse reactions, providing more guidance for clinical use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1312 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GV-971
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
GV-971
Intervention Description
Administered PO
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered PO
Primary Outcome Measure Information:
Title
Change from baseline in the ADAS-cog/12 score
Description
Change from baseline in Alzheimer's Disease Assessments Scale - cognitive (ADAS-cog/12) scale total score. The total score of ADAS-cog/12 is 0-75, with higher scores mean a worse outcome.
Time Frame
Baseline, 36 weeks
Title
Change from baseline in ADCS-ADL23 score
Description
Change from baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living-23-item Scale (ADCS-ADL23) score in moderate AD participants. The total score of ADCS-ADL23 is 0-78, with higher scores mean a better outcome.
Time Frame
Baseline, 36 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in MMSE score
Description
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.
Time Frame
Baseline, 36 weeks
Title
Change from baseline in the CIBIC-Plus score
Description
Change from baseline on Clinician's Interview-Based Impression of Change Plus (CIBIC-Plus) scale total score. The total score of CIBIC-Plus is 1-7, with higher scores mean a worse outcome.
Time Frame
Baseline, 36 weeks
Title
Change from baseline in NPI score
Description
Change from baseline in Neuropsychiatric Inventory (NPI) score. The total score of NPI is 0-144, with higher scores mean a worse outcome.
Time Frame
Baseline, 36 weeks
Title
Change from baseline in ADCS-ADL23 score
Description
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.
Time Frame
Baseline, 36 weeks
Other Pre-specified Outcome Measures:
Title
Change from baseline on A-beta protein of CSF
Description
Change from baseline on biomarkers of CSF A-beta protein after 36 weeks of treatment.
Time Frame
Baseline, 36 weeks
Title
Change from baseline on Tau protein of CSF
Description
Change from baseline on biomarkers of CSF Tau protein after 36 weeks of treatment.
Time Frame
Baseline, 36 weeks
Title
Change from baseline on biomarkers of Th1/Th2 cell subtypes
Description
Change from baseline on biomarkers of peripheral blood immune cell subtypes of Th1/Th2 after 36 weeks of treatment.
Time Frame
Baseline, 36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. Hachinski Ischemic Score (HIS) scale total score ≤ 4. Hamilton Rating Scale for Depression/17 items (HAMD) total score ≤ 10. Brain MRI scan show the highest possibility of AD. Have a reliable study partner/caregiver. Sign the informed consent form. 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 10 minutes of rest. Major medical illness or unstable medical condition within 12 months of screening. Concomitant use of donepezil, rivastigmine, galanthamine, huperzine A, memantine, or aducanumab within 6 moinths prior to baseline. Inadequate hepatic function. Inadequate organ function. ECG clinically significant abnormalities.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Medical Director, Ph. D
Phone
+86 21 50504988
Ext
8821
Email
xinxianliang@greenvalleypharma.com
Facility Information:
Facility Name
Beijing Anding Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qinge Zhang
Facility Name
Beijing Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haibo Chen
Facility Name
Xuanwu Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianping Jia
Facility Name
The First Affiliated Hopsital of Xiamen University
City
Xiamen
State/Province
Fujian
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kunmu Zheng
Facility Name
The First Affiliated Hopsital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qin Liu
Facility Name
The Second Affiliated Hopsital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Liu
Facility Name
The First People's Hospital of Nanning
City
Nanning
State/Province
Guangxi
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xianfeng Li
Facility Name
Shijiazhuang People's Hospital
City
Shijiazhuang
State/Province
Hebei
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huiying Zhao
Facility Name
The First Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qinying Ma
Facility Name
The Second Hopsital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yaling Liu
Facility Name
Tangshan Workers' Hospital
City
Tangshan
State/Province
Hebei
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongqiu Li
Facility Name
The First Affiliated Hopsital of Nanyang Medical College
City
Nanyang
State/Province
Henan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qian Deng
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiewen Zhang
Facility Name
Chenzhou First People's Hospital
City
Chenzhou
State/Province
Hunan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoxi Yao
Facility Name
Yueyang Central Hospital
City
Yueyang
State/Province
Hunan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiang Huang
Facility Name
Huai'an Second People's Hospital
City
Huai'an
State/Province
Jiangsu
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liandong Zhao
Facility Name
Nanjing Brain Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rong Lu
Facility Name
Affiliated Hospital of Nantong University
City
Nantong
State/Province
Jiangsu
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maohong Cao
Facility Name
The Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guiyun Cui
Facility Name
Yangzhou First People's Hospital
City
Yangzhou
State/Province
Jiangsu
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tieyu Tang
Facility Name
Jiujiang University Affiliated Hospital
City
Jiujiang
State/Province
Jiangxi
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangbin Wu
Facility Name
The Second Affiliated Hopsital of Nanchang University
City
Nanchang
State/Province
Jiangxi
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenyu Tang
Facility Name
The First Bethune Hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Sun
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Li
Facility Name
Shandong Provincial Hospital
City
Jinan
State/Province
Shandong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yifeng Du
Facility Name
Yantai Yuhuangding Hospital
City
Yantai
State/Province
Shandong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhigang Liang
Facility Name
Tianjin People's Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meiyun Zhang
Facility Name
The Second Hospital of Jiaxing
City
Jiaxing
State/Province
Zhejiang
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanping Wang

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

An Efficacy and Safety Study of Sodium Oligomannate (GV-971) for the Treatment of Alzheimer's Disease

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