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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
800
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.
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.
Time frame: Baseline, 48 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 48 weeks, 96 weeks
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