The double blind, placebo controlled trial, part of the €6m EU-funded LipiDidiet project, found daily consumption of Souvenaid improved the ability of early Alzheimer’s (pre-dementia) sufferers to perform everyday tasks and reduced brain shrinkage, particularly the hippocampal cranial zone.
LipiDidiet project manager Tobias Hartmann, a neurologist from the University of Saaland in Germany, told us the results were encouraging and that a new EU project called MindAD was underway observing the effects of consuming Souvenaid combined with exercise.
“This research is significant because there is limited pre-dementia data and pharmaceutical options to treat Alzheimer’s are not available,” said professor Hartmann.
He said the study results, presented this month at the Advances in Alzheimer's Therapy (AAT) congress in Athens, Greece, showed real-life benefits like paying bills among the 160 or so early Alzheimer’s sufferers that drank the 125 ml bottles of Souvenaid daily.
“It had a real impact on lives,” the professor said. It is estimated about 47 million people suffer from Alzheimer’s globally.
But professor Hartmann expressed disappointment the trial did not achieve significance for its primary endpoint – overall cognitive function.
“But earlier estimates of cognitive decline going back ten years or more that fed this endpoint have been shown to be over-estimated, so the decline in controls was less than expected,” he reflected.
321 Europeans with early Alzheimer’s as determined by biomarker and behavioural assessment, were split into two groups, with the control group consuming a daily iso-caloric drink that looked and tasted like Souvenaid.
The non-achieved primary cognition endpoint was tested via 'CERAD (Consortium to Establish a Registry for Alzheimer’s Disease) 10-word immediate recall, delayed recall and recognition, category fluency and letter digit substitution test'.
The achieved secondary endpoints were measured by 'episodic memory, executive function/working memory composite and a complete composite score consisting of 16 subtests, progression to dementia, blood and CSF (cerebrospinal fluid) biomarkers, tolerance and safety'.
Significant differences were measured for hippocampal and whole-brain atrophy, and favourable effects for episodic memory.
Danone-Nutricia officially launched Souvenaid in early 2013 as a medical food in the UK and other European markets, meaning it could only be purchased via prescription under EU Food for Special Groups laws.
It contains 1200mg of DHA (docosahexaenoic acid) and 300mg of EPA (eicosapentaenoic acid) plus uridine monophosphate, choline, phospholipids and B vitamins.
It features as a medical food in the UK, Ireland, Germany, Austria, Belgium, the Netherlands, Spain, Italy, Greece, Finland, Sweden, Australia and latin America and is about to be launched in south east Asia.
It sells under prescription for about €4 a bottle in strawberry, vanilla and cappuccino flavours.
Presented at Advances in Alzheimer's Therapy (AAT) congress, Athens, Greece; March 9-12 2016.
Authors: Tobias Hartmann et al