Fortasyn Connect, the active component of Souvenaid, was developed based on the premise that a specific combination of nutrients enhances synaptic functions. It consists predominantly of omega 3 (1500 mg per day of docosahexaenoic acid and eicosapentaenoic acid), phospholipids, choline, high doses of vitamin B (B12, B6, and folic acid), vitamin E, vitamin C, selenium, and uridine monophosphate. Souvenaid is a marketed product of Nutricia and is taken as a once-a-day drink with breakfast. Previous trials showed benefits in mild Alzheimer's disease dementia. The current study investigated the effects of Fortasyn connect on cognition and related measures in prodromal Alzheimer's disease.
A commentary notes several important lessons from the LipiDiDiet trial:
• LipiDiDiet, together with past trials, does not provide sufficient evidence for the use of Fortasyn Connect in mild or prodromal Alzheimer's disease.
• Most of participants who were screened were included in the trial, which was attributed to participants primarily coming from memory clinic populations with recent detailed assessments. This limits the external validity of this study outside of specialised memory clinics.
• Baseline memory scores were very similar to mild Alzheimer's disease, with a higher-than-expected conversion rate to Alzheimer's disease during the trial. Despite this extent of impairment, changes in the primary outcome were not significant, highlighting the limitations and challenges of constructing composite outcomes in the absence of validated data relevant to the population studied.
• Intervention appears to be targeting the disease at a late stage. A preplanned analysis in LipiDiDiet suggested that better baseline cognitive function (Mini-Mental State Examination score ≥26) was associated with a better drug placebo response in the clinical dementia rating-sum of boxes, hippocampal volume, and the primary endpoint in the per-protocol analysis.