Clinical trial NCT05908695: 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
Overall status: RECRUITING
Phase: PHASE4
Conditions: Alzheimer's Disease
Lead sponsor: Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-06-18
Enrollment: 1312
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change from baseline in the ADAS-cog/12 score
timeFrame: Baseline, 36 weeks
measure: Change from baseline in ADCS-ADL23 score
timeFrame: Baseline, 36 weeks
Secondary outcomes:
measure: Change from baseline in MMSE score
timeFrame: Baseline, 36 weeks
measure: Change from baseline in the CIBIC-Plus score
timeFrame: Baseline, 36 weeks
measure: Change from baseline in NPI score
timeFrame: Baseline, 36 weeks
measure: Change from baseline in ADCS-ADL23 score
timeFrame: Baseline, 36 weeks
Other outcomes:
measure: Change from baseline on A-beta protein of CSF
timeFrame: Baseline, 36 weeks
measure: Change from baseline on Tau protein of CSF
timeFrame: Baseline, 36 weeks
measure: Change from baseline on biomarkers of Th1/Th2 cell subtypes
timeFrame: Baseline, 36 weeks
Locations:
city: Huainan
country: China
facility: Huainan First People's Hospital
state: Anhui
city: Beijing
country: China
facility: Beijing Anding Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Tongren Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking University Shougang Hospital
state: Beijing
city: Beijing
country: China
facility: The First Medical Center, Chinese PLA General Hospital
state: Beijing
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
city: Xiamen
country: China
facility: The First Affiliated Hopsital of Xiamen University
state: Fujian
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Chinese Medicine
state: Guangdong
city: Guangzhou
country: China
facility: The Affiliated Brain Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hopsital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The Second Affiliated Hopsital of Guangzhou Medical University
state: Guangdong
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
state: Guangdong
city: Nanning
country: China
facility: The First People's Hospital of Nanning
state: Guangxi
city: Shijiazhuang
country: China
facility: Shijiazhuang People's Hospital
state: Hebei
city: Shijiazhuang
country: China
facility: The First Hospital of Hebei Medical University
state: Hebei
city: Shijiazhuang
country: China
facility: The Second Hopsital of Hebei Medical University
state: Hebei
city: Tangshan
country: China
facility: Tangshan Workers' Hospital
state: Hebei
city: Nanyang
country: China
facility: The First Affiliated Hopsital of Nanyang Medical College
state: Henan
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Wuhan
country: China
facility: Wuhan Hospital of Traditional Chinese and Western Medicine (Wuhan No.1 Hospital)
state: Hubei
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Chenzhou
country: China
facility: Chenzhou First People's Hospital
state: Hunan
city: Yueyang
country: China
facility: Yueyang Central Hospital
state: Hunan
city: Huai'an
country: China
facility: Huai'an Second People's Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Brain Hospital
state: Jiangsu
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Yangzhou
country: China
facility: Yangzhou First People's Hospital
state: Jiangsu
city: Jiujiang
country: China
facility: Jiujiang University Affiliated Hospital
state: Jiangxi
city: Nanchang
country: China
facility: The Second Affiliated Hopsital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: The First Bethune Hospital of Jilin University
state: Jilin
city: Hohhot
country: China
facility: Inner Mongolia International Hospital of Mongolian Medicine
state: Neimenggu
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Qingdao
country: China
facility: Qilu Hospital of Shandong University (Qingdao)
state: Shandong
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Air Force Medical University （Tangdu Hospital of Air Force Medical University）
state: Shanxi
city: Xi'an
country: China
facility: Xi'an Mental Health Center
state: Shanxi
city: Xianyang
country: China
facility: Xianyang Hospital of Yan'an University
state: Shanxi
city: Chengdu
country: China
facility: Hospital of Chengdu University of TCM
state: Sichuan
city: Tianjin
country: China
facility: Tianjin People's Hospital
state: Tianjin
city: Urumqi
country: China
facility: The Affiliated Hopsital of Inner Mongolia Medical University
state: Xinjiang
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Hangzhou
country: China
facility: The First Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
city: Jiaxing
country: China
facility: The Second Hospital of Jiaxing
state: Zhejiang
Study officials:
References: