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
Study design of LipiDiDiet
- 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