Sodium oligomannate, also known as GV-971, is a mixture of carbohydrates derived from brown algae. In a clinical trial in China, sodium oligomannate treatment in Alzheimer’s patients improved cognitive functions. Subsequently, a phase 3 clinical trial in the US and Canada was initiated, but it was suspended due to the COVID-19 pandemic. Sodium oligomannate is marketed in China for the treatment of Alzheimer’s disease, but it is currently not available outside of China. No studies have tested whether sodium oligomannate improves cognitive function or prevents age-related cognitive decline in healthy adults.
A phase 3 clinical trial in China reported improved cognitive functions in Alzheimer’s patients. However, it is not known whether sodium oligomannate is effective in populations outside of China or whether it provides cognitive benefit in people without dementia. Our search identified:
No clinical trials have evaluated whether sodium oligomannate improves cognitive function or prevents age-related cognitive decline in healthy people. A phase 3 clinical trial in China reported cognitive benefits in people with mild-to-moderate Alzheimer’s patients [1], but whether similar cognitive benefits occur in populations outside of China, or in people without dementia remain to be determined.
Preclinical studies suggest that sodium oligomannate may improve cognitive function by altering the gut microbiome and reducing inflammation in the brain [2; 3]. However, these effects in the gut and brain have not been confirmed in humans.
In a phase 3 double-blind randomized controlled trial in China that enrolled 818 patients with mild-to-moderate Alzheimer’s disease, treatment with sodium oligomannate (900 mg daily, orally) for 36 weeks resulted in significantly better cognitive scores compared to the placebo group [1]. One limitation to this study was the lack of requirement for Alzheimer’s related biological markers (e.g., amyloid) at screening, and therefore, the study likely included participants who had dementia that was not due to Alzheimer’s disease. Some critics have pointed out that the effectiveness of sodium oligomannate may have been exaggerated by the precipitous cognitive decline in the placebo group [4]. Although a large phase 3 trial in the US and Canada was initiated in mild-to-moderate Alzheimer’s disease patients, the study was suspended due to the COVID-19 pandemic [5].
In a safety analysis of sodium oligomannate, the overall incidence of adverse reactions was not significantly different between the sodium oligomannate and placebo groups [6]. Common adverse reactions that were more frequent with sodium oligomannate than placebo included dry mouth, blood in the urine, elevated liver enzymes (ALT, AST), elevated bilirubin, and increased LDL cholesterol. In the phase 3 double-blind randomized controlled trial of 818 patients with mild-to-moderate Alzheimer’s disease, treatment with sodium oligomannate (900 mg daily, orally) for 36 weeks resulted in slightly higher incidences of hyperlipidemia and the common cold compared to the placebo group [1]. In people with serious hepatic or renal impairment, monitoring of hepatic or renal function is required during treatment with sodium oligomannate [6].
NOTE: This is not a comprehensive safety evaluation or complete list of potentially harmful drug interactions. It is important to discuss safety issues with your physician before taking any new supplement or medication.
Sodium oligomannate is not marketed outside of China. In China, sodium oligomannate is approved for the treatment of mild-to-moderate Alzheimer’s disease. The dose used in the phase 3 trial in China that showed cognitive benefits in mild-to-moderate Alzheimer’s disease was 900 mg/day (3 capsules of 150 mg, taken twice daily)[1].
Full scientific report (PDF) on Cognitive Vitality Reports