Efficacy of Souvenaid in mild Alzheimer’s disease: a randomized, controlled trial.
The results of Souvenir II were published in the Journal of Alzheimer’s Disease in 2012.
To evaluate the effect of Souvenaid on memory in drug-naive patients with mild Alzheimer’s disease over a 24-week period.
Patients with mild AD; AD drug-naive
Primary Outcome on Memory
- Memory function domain score (z-score) of the Neuropsychological Test Battery (NTB)
- Rey Auditory Verbal Learning Test (RAVLT) immediate recall, delayed recall and recognition performance
- Wechsler Memory Scale-revised (WMS-r) verbal paired associates immediate and delayed recall
- Executive function domain score (z-score)
- Total NTB composite score
- Individual item scores NTB
- Assessments of functional ability (Disability Assessment for Dementia scale
- EEG data
- Nutritional measures (blood nutritional markers indicating uptake)
The Souvenir II study was a randomised, controlled, double-blind, parallel-group trial conducted in 259 drug-naive 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.
Adapted from Scheltens P et al. (2012)
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.
Publication abstract: http://www.ncbi.nlm.nih.gov/pubmed/22766770
- 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.