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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Alzheimer's Disease

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


Participation Criteria
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Eligibility Criteria
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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.

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, 36 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 in moderate AD participants. The total score of ADCS-ADL23 is 0-78, with higher scores mean a better outcome. | Baseline, 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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, 36 weeks | 
| 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. | Baseline, 36 weeks | 
| 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 | 
| 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 |