A new study investigating the effects of a nutrient drink for Alzheimer's disease has led to very different headlines in the media. While BBC News tells us the "Alzheimer's nutrient drink falters in clinical trial", the Daily Mirror reports the drink "could help stave off Alzheimer's disease, according to scientists".
The trial investigated the effects of Fortasyn Connect – a patented mix of vitamins and minerals, found in the drink Souvenaid – on memory in individuals showing early signs of Alzheimer's disease.
It was hoped those receiving the drink would experience less memory decline than would usually be expected.
Just over 300 participants were given either Souvenaid or a control drink for two years – both looked and tasted the same, so people didn't know which they had. The main aim was to see whether those who drank Souvenaid had better results across a range of memory tests than those who didn't.
The researchers found no difference in this main outcome, but there were some positives in secondary outcomes: those taking the drink had slightly less brain shrinkage and slightly better cognitive scores. However, there was still no difference in the number of people from each group that went on to develop dementia.
Overall, the study provides no evidence that this drink can prevent or slow the progress of dementia.
Regular exercise, a healthy diet, and avoiding drinking heavily and smoking seem to do more to reduce your dementia risk than any nutrient drinks currently available.
The study was carried out by researchers from international institutions in Finland, Germany, the Netherlands, Sweden and the US, and was funded by the European Commission 7th Framework Programme. Many of the researchers involved have worked or are currently working for pharmaceutical companies.
The study was published in the peer-reviewed medical journal The Lancet and is free to read online.
There were split reports in the media on this study, with the Mirror and Mail Online claiming the nutrient drink could "stave off dementia".
Thankfully, BBC News provided a more accurate summary, reporting that the trial found no improvements in memory and thinking.
This was a double-blinded randomised controlled trial (RCT) investigating the effects of a nutrient drink on brain function in individuals showing early signs of Alzheimer's disease.
The trial, called LipiDiDiet, investigated the benefits of the drink Souvenaid, which contains the Fortasyn Connect multinutrient mix. Earlier studies suggested the drink was well tolerated and may improve certain aspects of memory but didn't slow brain decline overall.
The first part of the LipiDiDiet trial ran for 12 months. This was followed by an optional extension to 24 months, which is what was reported on here.
Double-blind RCTs like this are one of the most reliable ways of assessing the effects of an intervention, as the study design limits the chance that patient characteristics and other confounders are influencing any links.
The 24-month LipiDiDiet trial was carried out across 11 different sites. Researchers from memory clinics recruited 311 participants, aged 55 to 85 years, who had been diagnosed with "prodromal Alzheimer's disease". This term describes people who have normal cognitive function (as defined by the Mini-Mental State Examination) but are experiencing some memory problems and have some physical changes to the brain associated with early-stage dementia.
Eligible participants were randomised to receive either a placebo drink or the Fortasyn Connect-containing Souvenaid drink (125ml) once a day. None of the participants or assessors knew which individuals were taking the treatment.
Participants took their drinks home and reported consumption in a daily diary. To ensure compliance, motivation and safety, participants were contacted by phone once a month during the first 6 months of the trial and once every 2 months thereafter.
Individuals were assessed at baseline, 6, 12 and 24 months using a battery of neuropsychological tests (NTB) – which tested several aspects of cognitive performance, including written memory and visual memory recall – as well as brain scans. Individuals visited the study nurse or physician every 3 months in the first year and every 6 months in the second year.
The main outcome of interest was change in NTB score over the 24 months. A significant decline in NTB score is often indicative of worsening Alzheimer's.
Other outcomes measured included cognitive change and brain volume. Blood tests were also used to assess the safety of the product.
The nutrient drink had no effect on the main outcome (change in NTB) at 24 months. The average score change with Fortasyn Connect was -0.028, compared with -0.108 in the placebo group. This gave a between-group difference of 0.098 (95% confidence interval [CI] -0.041 to 0.237), which was not statistically significant.
With regard to the secondary outcomes, there was slightly less reduction in brain volume in the Fortasyn Connect group versus the control group. Overall clinical dementia scores were also slightly worse in the control group than the Fortasyn Connect group. However, there was no significant difference between the number of participants diagnosed with dementia by 24 months, which was 62 people (41%) in the Fortasyn Connect group and 59 (37%) in the placebo group.
Compliance was reported to be high, and there was no difference between groups in the number of adverse events. No serious adverse effects were thought to be related to the drink.
The researchers said: "The intervention had no significant effect on the NTB primary endpoint over 2 years in prodromal Alzheimer's disease. However, cognitive decline in this population was much lower than expected … group differences on secondary endpoints of disease progression measuring cognition and function [and brain shrinkage] were observed.
"Further study of nutritional approaches with larger sample sizes, longer duration, or a primary endpoint more sensitive in this pre-dementia population, is needed."
This trial provides valuable evidence about the effects of a nutrient drink, Souvenaid, on memory in individuals with early signs that they may develop Alzheimer's disease.
Importantly, the researchers found no significant effect on the main outcome their study looked at (memory). They did find less brain shrinkage and slightly better cognitive scores in the experimental group, but this still didn't lead to any reduction in the number who were diagnosed with dementia by the end of the study.
This trial therefore provides no evidence that Souvenaid/Fortasyn Connect can help to prevent or slow Alzheimer's developing in people with early signs of cognitive decline.
In 2010, Behind the Headlines reported the findings of an early-stage 12-week study of the same Souvenaid/Fortasyn Connect drink. That study found some changes to verbal recall but, again, no overall effect on cognitive outcomes.
As Dr Doug Brown, director of research at Alzheimer's Society, commented on the present study:
"This trial of Souvenaid did not meet the success criteria that would be needed for developing new drugs, so we cannot be confident of the drink's benefits … we certainly can't conclude that the drink slows progression of Alzheimer's disease.
"People who are worried about their memory should not rush out and buy this drink without first talking to their doctor to find out if it could be suitable for them. There are many causes of memory decline, including normal ageing, so it's important people are investigated for underlying Alzheimer's disease before taking this medical drink, or any kind of treatment."
There's no guaranteed way to prevent dementia – particularly Alzheimer's disease, which doesn't have a fully established cause. However, there are things you can do to try to reduce your risk: