The level of evidence is downgraded by inconsistecy.
A Cochrane review [Abstract] 1 included 3 randomised, placebo-controlled trials investigating a dietary supplement (Souvenaid® ) in 1097 community-dwelling participants with Alzheimer's disease. One study each included participants with prodromal AD, mild AD dementia and mild-to-moderate AD dementia. The data of the studies were not pooled because of differences between them in the severity of the participants' symptoms and in the way the researchers measured their results.
One trial investigated the incidence of dementia in people with prodromal AD at baseline, and found little to no difference between the Souvenaid® group and the placebo group after 24 months (RR 1.09, 95% CI 0.82 to 1.43; 1 trial, 311 participants).In prodromal AD, and in mild and mild-to-moderate Alzheimer's disease dementia, Souvenaid® probably resulted in little or no difference in global or specific cognitive functions. Everyday function, or the ability to perform activities of daily living, were measured in mild and mild-to-moderate AD dementia. Neither study found evidence of a difference between the groups after 24 weeks of treatment. Two studies investigated combined cognitive-functional outcomes with the Clinical Dementia Rating Sum of Boxes and observed conflicting results. Souvenaid® probably resulted in slight improvement, which was below estimates of meaningful change, in participants with prodromal Alzheimer's disease after 24 months, but probably had little to no effect in mild-to-moderate Alzheimer's disease dementia after 24 weeks.Adverse effects observed were low in all trials, and the available data were insufficient to determine any connection with Souvenaid® .
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