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The 24 month RCT phase of the LipiDiDiet trial has now been completed with first results announced during the Advances in Alzheimer's Therapy (AAT) conference in Athens in March 2016. Additional data was recently presented during the AAIC 2016 congress in Toronto. There are 4 additional, optional blinded extension periods which will continue to yield further data as well as additional analyses and the publication in due course.

To investigate the effect of Souvenaid on cognition, function and brain volume, in patients with prodromal AD.

The primary outcome measure is cognitive performance assessed by a modified version of the Neuropsychological Test  Battery (NTB).

The EU-funded LipiDiDiet™ trial is a randomised, controlled, double-blind, parallel-group study, of 311 patients with prodromal Alzheimer’s disease. Patients were randomised to receive Souvenaid or an isocaloric control drink and were assessed on a variety of cognitive and functional measures, as well as biomarkers. These measures were assessed at baseline and thereafter 6 monthly over a year period. The 24 month RCT phase was completed in 2015 with first results announced early in 2016.

  • LipiDiDiet study design

    LipiDiDiet study design

    Study design of LipiDiDiet

References

  1. Soininen H, Visser P, Kivipelto M, Hartmann T. A clinical trial investigating the effects of fortasyn connect (souvenaid) in prodromal Alzheimer's disease: results of the LipiDiDiet study. Neurobiology of Aging. 2016;39:S23