Souvenir i

Souvenir_FINAL-Button
Efficacy of a medical food in mild Alzheimer’s disease: A randomized, controlled trial.
The results of Souvenir I were published in Alzheimer’s and Dementia in 2010.

Objective

To evaluate the effect of Souvenaid on cognitive function in drug-naïve patients with mild Alzheimer’s disease over a 12-week period.

 Study Design

Patients with mild AD; AD drug-naive

Co-primary outcomes on Memory and Cognition

  • Delayed verbal recall Wechsler Memory Scale revised (WMS-r)
  • 13- item modified Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-Cog)

Additional outcomes

  • Nutritional measuers (e.g. DHA percentage of fatty acids in erythrocyte membrane and plasma homocysteine levels)

Souvenir I study was a multinational, randomised, controlled, double-blind trial conducted in 225 drug-naïve patients with mild Alzheimer’s disease. Patients had a MMSE of 20-26 inclusive. Patients were randomised to receive Souvenaid (n=106) or an isocaloric control drink (n=106) for 12 weeks.

Results

Adapted from Scheltens P, et al. (2010) and de Wilde MC, et al. (2011)

At week 12, the Souvenaid group demonstrated a significant improvement in the delayed verbal recall task versus the control group (p=0.021), 40% of the Souvenaid group experienced an improvement in WMS-r delayed recall compared with 24% in the control group. There was no significant change in scores on the modified ADAS-cog in either group. Souvenaid was as well tolerated as the control drink and product compliance was high (94%). The drop-out rate in the study was low: 6.6% and 4.8% in the first 12 weeks.

Conclusion

Souvenaid is well tolerated and improves memory performance in mild Alzheimer’s disease patients.

 

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References

  1. Scheltens P, Kamphuis PJ, Verhey FR, Olde Rikkert MG, Wurtman RJ, Wilkinson D, Twisk JW, Kurz A.  Efficacy of a medical food in mild Alzheimer’s Disease: a randomized controlled trial. Alzheimer’s & Dementia. 2010;6:1-10.
  2. de Wilde MC, et al. Utility of imaging for nutritional intervention studies in Alzheimer’s disease. European Journal of Pharmacology. 2011;668 (Supp I):559-69.