P3–306: A randomized controlled trial investigating the effects of Souvenaid in prodromal Alzheimer's disease: Baseline characteristics of the LipiDiDiet study

Souvenaid ®, containing the specific nutrient combination Fortasyn ® Connect 1, is designed to support synapse formation and function in patients with Alzheimer's disease (AD). The nutrients in Fortasyn Connect are precursors and cofactors for the formation of neuronal membranes, and increasing their intake can promote synaptogenesis. Two earlier randomized controlled trials (RCTs) have shown that Souvenaid improves memory performance in drug-naïve mild AD patients (MMSE 20–26 and MMSE≥20), indicating that Souvenaid is efficacious in the early phases of AD. The 'LipiDiDiet' study 2 is one of the first RCTs in prodromal AD, investigating the effects of Souvenaid on cognition. The LipiDiDiet study is an ongoing 24-month, double-blind, parallel-group RCT investigating the effects of Souvenaid in 300 prodromal AD subjects (criteria Dubois, 2007). Subjects are randomly assigned to Souvenaid or an iso-caloric control product. Primary outcome measure is cognitive functioning, assessed by a modified version of the Neuropsychological Test Battery (Harrison, 2007). Secondary outcome measures include progression to AD, cognitive performance, functional abilities (ADCS-ADL), depression (MADRS), MRI atrophy rate, plasma and CSF biomarkers, safety, tolerance and nutritional parameters. Main study outcomes are assessed at baseline and after 6, 12 and 24 months of intervention. Baseline characteristics of the study population are analyzed. Preliminary analysis of baseline data from 213 randomized subjects (47.9% male, enrolled until July 2012) showed that subjects had a mean age of 71.8±6.9 years, MMSE score of 26.6±2.0 and ADAS-cog score of 19.7±7.8. Baseline biomarker data from a subsample of subjects (n=22) showed a CSF β-amyloid 1–42/1–40x10 ratio of 1.89±0.71, CSF total tau of 465.5±269.6 pg/ml, CSF phosphorylated tau of 74.5±35.6 pg/ml and MTA score of 1.64±1.00 (MRI evidence for medial temporal lobe atrophy). Last subject randomized in the study is expected early 2013. Therefore, baseline characteristics of the total study population will be presented at the conference. Baseline characteristics of the study population included in the LipiDiDiet study so far are as expected for subjects with prodromal AD.