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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 20101.
 

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

The delayed verbal memory task (derived from Wechsler Memory Scale-revised; WMS-r), primarily targeting memory function, and ADAS-cog (13-item modified Alzheimer's Disease Assessment Scale-cognition) to assess overall cognitive function were used. 

Souvenir I study is 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. 

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 

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

  • Souvenir I design

    Souvenir I design

    Patients were randomised to receive Souvenaid or an isocaloric control drink for 12 weeks [1]

  • Souvenir I baseline characteristics

    Souvenir I baseline characteristics

    Baseline characteristics were comparable between groups [1].

  • Souvenaid significantly improved memory (primary efficacy endpoint)

    Souvenaid significantly improved memory (primary efficacy endpoint)

    Changes in memory function test outcomes occurred after 12 weeks of consumption of Souvenaid (green) or a control drink (grey). With Souvenaid, there was a significant improvement in memory after 12 weeks (p = 0.021) [1]. 

  • Souvenaid safety profile: all reported adverse events (irrespective from the study product*)

    Souvenaid safety profile: all reported adverse events (irrespective from the study product*)

    There was no difference in the incidence of adverse events between groups. Most adverse events were classified as unrelated to the study intervention [1].

  • Souvenaid compliance

    Souvenaid compliance

    There were very high levels of compliance in both groups [1].

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.