Long-term Efficacy and Safety Study of GV-971

Study Overview
=================
Brief Summary
-----------------
Sodium Oligomannate Capsules (GV-971) has been approved for treatment of mild to moderate Alzheimer's disease and improving the cognitive function of patients. This study plans to observe, in the clinical patients, the long-term efficacy and safety of GV-971, as well as the changes in blood and gut microbiota biomarkers after treatment, to validate the mechanism of action of GV-971, in order to better guide the rational use of drug in clinical practice.

Official Title
-----------------
A Clinical Study to Evaluate the Long-term Efficacy and Safety of Sodium Oligomannate Capsules (GV-971)

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

Intervention / Treatment
-----------------
* Drug: Sodium Oligomannate Capsules (GV-971)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 50 to 85 years (inclusive), with no restriction on gender; Patients who met criteria for probable AD by National Institute on Aging and Alzheimer's Association (NIA-AA) diagnostic criteria; Patients with mild to moderate AD as characterized by Mini-Mental State Examination (MMSE) scores between 11 and 26, inclusive; Patients who have received at least primary education and have capacity to complete the measurement of cognition and other tests as specified in the protocol; Patients receiving GV-971 treatment prescribed by clinicians; Sign the informed consent form. Exclusion Criteria: Patients who have received GV-971 treatment within 6 months prior to screening; Patients who may be allergic to Sodium Oligomannate Capsules as judged by the investigator; Female participants who are pregnant or lactating; Patients who cannot cooperate to complete the follow-up inquiries; Any other diseases or conditions that are inappropriate to participate in this clinical trial in the opinion of the investigator.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sodium Oligomannate Capsules (GV-971)<br>The recommended dose regimen for subjects: GV-971 450 mg (3 capsules) per dose, bid, po. in morning and evening | Drug: Sodium Oligomannate Capsules (GV-971)<br>* Sodium Oligomannate Capsules, each capsule contains 150 mg of sodium oligomannate. The recommended treatment is oral administration, 450 mg (3 capsules) per dose, bid, in morning and evening.<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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in 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, 96 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, 48 weeks, 96 weeks | 
| Change from baseline in ADCS-ADL score | Change from baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living; 23-item Scale (ACDS-ADL23) score. The total score of ADCS-ADL23 is 0-78, with higher scores mean a better outcome. | Baseline, 48 weeks, 96 weeks | 
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | The incidence of adverse events and adverse reactions of vital signs, laboratory tests, electrocardiogram, and early withdrawal from the study in patients treated with GV-971. | 48 weeks, 96 weeks |