Souvenaid: help for people with Alzheimer’s disease?
Published in Health News and Evidence
Date published: About this date
Souvenaid is a dietary supplement marketed as a medicinal food for the treatment of early Alzheimer’s disease (AD). It is purported to improve cognitive performance by supporting synapse formation and function.
Three randomised controlled trails failed to show a significant effect of Souvenaid in decreasing the rate of cognitive decline or delaying AD progression. There may be a small effect on memory performance in drug-naïve persons in the very early stages of disease.
Souvenaid is a dietary supplement marketed as a daily drink and providing a range of nutrients including omega-3 fatty acids (EPA and DHA), phospholipids, choline, uridine monophosphate, vitamins E, C, B12, B6, folic acid and selenium.1
The choice of additives in Souvenaid is based on the biochemical synthesis pathway for phosphatidylcholine, a major constituent of synaptic membranes.1
The hypothesis is that increasing the systemic concentration of nutrients required for the formation of phosphatidylcholine will increase synapse formation and function and reduce the cognitive decline in patients with AD.2,3
This is based on the observation that the pathogenesis of AD involves the loss of synapses in addition to the extraneuronal deposition of proteins.2-4
Efficacy and safety of Souvenaid compared with placebo has been studied in three randomised controlled trials involving 1011 people for a maximum of 24 weeks.2-4
In all three studies patients were excluded based on broad exclusion criteria that included consumption of oily fish more than twice a week and supplementation with omega-3 fatty acids.2-4 Patients were also excluded if they had experienced a recent change in dose of lipid-lowering medicines, antidepressants2-4 or antihypertensives.2,3 In addition, in the two studies of mild AD, patients were excluded if they had taken any indicated AD therapy.2,4
In two studies using the Alzheimer’s Disease Assessment Scale – Cognitive Subscale no significant improvement in cognitive function was observed.3,4 In a third study no significant improvement occurred over 24 weeks in total composite score of the Neuropsychological Test Battery (NTB).
Although these findings suggest Souvenaid has no effect on AD progression, in the study observing NTB outcomes there was a small but significant improvement compared with placebo in the memory domain subscore of the NTB when expressed as a 24-week trajectory (p = 0.023), but not as absolute change from baseline to 24 weeks (p = 0.090).2
In another study in patients with mild AD, despite no effect on the Alzheimer’s Disease Assessment Scale, a statistically significant improvement in a verbal recall test (p = 0.026) was reported.4
All three studies reported that Souvenaid was well tolerated with no significant adverse events recorded.2-4
People with AD have very few treatment options — agents such as cholinesterase inhibitors and memantine have only demonstrated modest efficacy and variable response rates and are commonly associated with adverse effects.5
While Souvenaid is well tolerated and will probably not cause harm2-4,6 there is no evidence that it has any effect in decreasing the rate of cognitive decline or delaying AD progression, although there may be an effect on memory performance in drug-naïve persons in the very early stages of disease.2-4
However, Souvenaid in combination with approved AD medicines is well tolerated and may be taken by people who are also taking cholinesterase inhibitors, memantine or a combination.3
Note that Souvenaid is not listed on the Australian Therapeutic Goods Register and is not considered by any Australian regulatory body to be a therapeutic good. Souvenaid should be considered as a dietary supplement only.
Many people with AD will be taking nutritional supplements. Ensure patients and carers considering Souvenaid understand it does not replace these supplements. In addition, Souvenaid should not be used as a meal replacement and is not suitable for people with galactosaemia.6
- Nutricia D. How does Souvenaid work? Factsheet. 2013. [Online] (accessed 20 December 2013).
- Scheltens P, Twisk JW, Blesa R, et al. Efficacy of Souvenaid in mild Alzheimer's disease: results from a randomized, controlled trial. J Alzheimers Dis 2012;31:225–36. [PubMed]
- Shah RC, Kamphuis PJ, Leurgans S, et al. The S-Connect study: results from a randomized, controlled trial of Souvenaid in mild-to-moderate Alzheimer's disease. Alzheimers Res Ther 2013;5:59. [PubMed]
- Scheltens P, Kamphuis PJ, Verhey FR, et al. Efficacy of a medical food in mild Alzheimer's disease: A randomized, controlled trial. Alzheimers Dement 2010;6:1–10 e1. [PubMed]
- Therapeutic Guidelines: Psychotropic. eTG complete. 2013. [Online] (accessed 18 December 2013).
- Alzheimer's Australia. Souvenaid – A dietary treatment for mild Alzheimer's disease. 2013. [Fulltext] (accessed 18 December 2013).