To evaluate the effect of Souvenaid on memory in drug-free patients with mild Alzheimer’s disease over a 24-week period.
The primary outcome measure was the memory function domain Z-score of the Neuropsychological Test Battery (NTB) over 24 weeks.
The Souvenir II study is a randomised, controlled, double-blind, parallel-group trial conducted in 259 drug-free patients with mild Alzheimer’s disease from 27 centres in six European countries (the Netherlands, Germany, France, Belgium, Italy and Spain). Patients had MMSE ≥20, and were randomised to receive Souvenaid (n=130) or an isocaloric control drink (n=129) for 24 weeks.
Over the 24-week period, the NTB memory domain Z-score was significantly higher in the Souvenaid group versus the control group (p=0.023). Souvenaid compliance was >90% and no difference in the incidence of serious adverse events was observed compared to the control group.
Souvenaid is well tolerated and improves memory performance in mild Alzheimer’s disease patients.
Souvenir II study design
Patients were randomised to receive Souvenaid or an isocaloric control drink for 24 weeks .
Souvenir II baseline characteristics
Baseline characteristics were comparable between groups .
Souvenaid significantly improved memory improvement (primary efficacy endpoint)
This graph shows the difference in trajectories over time between Souvenaid and control groups during the 24-week intervention period. There was a significant improvement in the memory domain of the NTB over 24 weeks of treatment with Souvenaid (p = 0.023; mixed model for repeated measures, 2 degrees of freedom contrast) .
Souvenaid tolerability profile: all reported adverse events (irrespective of relationship to study product*)
There was no difference in the incidence of adverse events between groups . The majority of reported adverse events were assessed as being ‘not related’ or ‘unlikely to be related’ to the intervention .
The levels of compliance were very high in both groups .
- Scheltens P, Twisk JW, Blesa R, Scarpini E, von Arnim CA, Bongers A, Harrison J, Swinkels SH, Stam CJ, de Waal H, Wurtman RJ, Wieggers RL, Vellas B,Kamphuis PJ. Efficacy of Souvenaid in mild Alzheimer's disease: results from a randomized, controlled trial. J Alzheimer’s Dis. 2012;31:225–236.