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

Study Overview
=================
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.

Official 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)

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Drug: GV-971
* Drug: Placebo


Participation Criteria
=================
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. 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.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GV-971<br> | Drug: GV-971<br>* Administered PO<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Administered PO<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the ADAS-cog/11 score | 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. | Baseline, 48 weeks and 52 weeks | 
| Change from baseline in the ADCS-CGIC score | 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. | Baseline, 48 weeks and 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, 36 Weeks, 52 Weeks | 
| 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. | Baseline, 52 Weeks | 
| 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. | Baseline, 36 Weeks, 52 Weeks | 
| Change from baseline in NPI caregiver items | 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. | Baseline, 52 Weeks | 
| Change from baseline in ZBI score | Change from baseline in Zarit Burden Interview (ZBI) score. The total score of ZBI is 0-88, with higher scores mean a worse outcome. | Baseline, 52 Weeks | 
| Assess the efficacy of GV-971 throughout the OLE period | 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. | Baseline, 52 Weeks, 78 Weeks | 
| Assess the efficacy of GV-971 throughout the OLE period | 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. | Baseline, 52 Weeks, 78 Weeks |