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

Phase 3

Suspended

• Conditions: Alzheimer Disease
• Interventions: Drug: GV-971; Drug: Placebo

• Registration Number: NCT04520412
• Lead Sponsor: Green Valley (Shanghai) Pharmaceuticals Co., Ltd.

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 available

Study Timeline

• Study First Submitted: 2020-08-11
• Study First Submitted QC: 2020-08-18
• Study First Posted: 2020-08-20
• Study Start: 2020-10-27
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-18
• Last Update Posted: 2022-11-23
• Primary Completion: 2025-12
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 2046

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GV-971	GV-971	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in the ADCS-CGIC score	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.
Change from baseline in the ADAS-cog/11 score	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.

Secondary Outcome Measures

Name	Time	Method
Assess the efficacy of GV-971 throughout the OLE period	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.
Change from baseline in NPI score	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	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	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	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	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.

Trial Locations

Locations (168)

Cognitive Clinical Trials, LLC; 🇺🇸 Omaha, Nebraska, United States

Banner Alzheimer's Institute; 🇺🇸 Tucson, Arizona, United States

St. Joseph's Hospital and Medical Center; 🇺🇸 Phoenix, Arizona, United States

Banner Sun Health Research Institute; 🇺🇸 Sun City, Arizona, United States

Irvine Clinical Research; 🇺🇸 Irvine, California, United States

Sunwise Clinical Research; 🇺🇸 Lafayette, California, United States

Pharmacology Research Institute; 🇺🇸 Los Alamitos, California, United States

Pacific Research Network, Inc; 🇺🇸 San Diego, California, United States

Pacific Research Network; 🇺🇸 San Diego, California, United States

Syrentis Clinical Research; 🇺🇸 Santa Ana, California, United States

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