Objective: This meta-analysis evaluates the safety and effectiveness of sodium oligomannate in treating Alzheimer’s disease using data from randomized controlled trials.

Background: Alzheimer’s disease (AD) significantly impairs cognitive function and represents a major global health issue. The amyloid hypothesis highlights an imbalance in Aβ protein. Sodium oligomannate (GV-971), derived from marine sources, has shown promise in animal studies by reducing Aβ deposition and neuroinflammation. Further research aims to confirm its therapeutic benefits.

Design/Methods: We searched four electronic databases—PubMed, Scopus, WOS, and Cochrane—for randomized controlled trials (RCTs) comparing GV-971 to placebo in treating Alzheimer’s disease, from March 1, 2023, to April 1, 2023. This meta-analysis assessed outcomes using the Assessment Scale-Cognitive Subscale 12 (ADAS-COG12), Alzheimer’s Disease Cooperative Study–Activities of Daily Living Scale (ADCS-ADL), Neuropsychiatric Inventory (NPI), and evaluated safety and potential adverse effects.

Results: The analysis included three RCTs with a total of 1108 patients. For ADAS-COG12, sodium oligomannate showed a significant advantage over placebo (MD = −2.72, 95% CI [−5.43, −0.02], p = 0.05). However, the pooled analysis for ADCS-ADL and NPI did not show a significant difference between the two groups (MD = 1.80, 95% CI [−2.29, −5.89], p = 0.39) and (MD = −3.41, 95% CI [−12.26, 5.43], p = 0.45), respectively.

Conclusions: This meta-analysis indicates that GV-971 significantly improves ADAS-COG12 scores in Alzheimer’s disease patients compared to placebo. GV-971 demonstrates similar efficacy to donepezil in treating Alzheimer’s disease and has a favorable safety profile and tolerance.