European scientists have demonstrated that a nutritional drink, Fortasyn Connect, does not benefit broad cognitive function to the degree expected, but it can help to conserve brain tissue and memory in early, or prodromal, Alzheimer’s disease patients.
The clinical trial is part of the LipiDiDiet project, a large European study exploring the therapeutic and preventative effects of nutrition on neuronal and cognitive performance in aging, Alzheimer’s disease (AD) and vascular dementia.
Cognitive decline over the trial’s two-year period, however, was less than that anticipated when the study was designed a decade ago, so cognitive differences between its treatment and control groups were not found to be statistically significant.
“Today’s results are extremely valuable as they bring us closer to understanding the impact of nutritional interventions on prodromal AD which we are now better at diagnosing but unable to treat due to a lack of approved pharmaceutical options. The LipiDiDiet study illustrates that this nutritional intervention can help to conserve brain tissue and also memory and patients’ ability to perform everyday tasks — possibly the most troubling aspects of the disease. We look forward to the results of subsequent analyses and the six year-extension study which will provide further insights,” Professor Hilkka Soininen, MD, PhD, a professor in Neurology from the University of Eastern Finland, who headed the trial, said in a press release.
Fortasyn Connect was the drink selected by the team of experts from 19 European institutes. The aim of the multicenter, randomized, and double-blind trial in 311 people with prodromal AD — memory problems not severe enough to be diagnosed as dementia — was to assess the effects of the nutritional drink on cognitive function, with patients randomly assigned to Fortasyn Connect or to an iso-caloric control product once per day.
Secondary endpoints included changes in brain volumes, the Clinical Dementia Rating Sum of Boxes (CDR-SB), a separate composite score of 16 subtests, progression to (AD) dementia, blood and CSF biomarkers, safety and tolerance, and a neuropsychological battery assessing episodic memory and executive function/working memory.
After two years, there was no marked difference in cognitive performance between the two groups. However, there were statistically significant differences between the active and control groups for whole-brain and hippocampal atrophy, as well as favorable effects for episodic memory and in the CDR Sum of Boxes.
Researchers are still conducting analyses for disease progression, and blood and CSF biomarkers.
Tobias Hartmann, the project’s coordinator, said: “We have known for a while that diet can reduce the risk of developing dementia. Indeed, certain nutrients have been found to have a neuroprotective effect on the brain. However translating this into an effective intervention hasn’t been easy because single nutrients simply aren’t powerful enough to fight a disease like Alzheimer’s alone. Today’s clinical trial results have shown that the key is combining certain nutrients, in order to increase their effect.
“This is exciting because it shows that in the absence of effective drug options, we really have found something that can help slow down some of the most distressing symptoms in prodromal AD; especially in those who started the intervention early. Indeed those patients who have lost the least cognitive function, have the most to gain,” he concluded.