The Lancet Neurology has published the results of the European LipiDiDiet clinical trial which examines the effect of a once-daily medical drink in people with the pre-dementia stage of Alzheimer’s.
Dr Doug Brown, Director of Research at Alzheimer’s Society, said:
“This study hints that a medical drink could slow the decline of thinking skills in people experiencing mild memory problems, who also have early signs of Alzheimer’s disease on a brain scan or a lumbar puncture test. This group of people don’t benefit from Alzheimer’s drugs, so this drink is one option to consider alongside regular exercise, avoiding smoking and eating a healthy, balanced diet to keep their memory sharp.
“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. Although there was less cognitive decline in people taking the daily drink over two years, the same number of people still went on to develop dementia as those who had a fake drink every day. 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.”
Prof. Robert Howard, Professor of Old Age Psychiatry, UCL, said:
“I see this as a negative trial. Treatment had no significant effect on the primary outcome, a composite neuropsychological test considered to be extremely sensitive to change at the early stages of Alzheimer’s disease or on the chances of developing diagnosable Alzheimer’s disease over the 24 months of the trial. Differences reported on one of the secondary cognitive ratings and on some of the MRI measures should be treated with caution in the absence of change on the primary outcome, the statistical limitations of interpreting these results and the sad history of persevering with trials of already failed treatments in Alzheimer’s disease.”
Prof. John Hardy, Professor of Neuroscience, UCL, said:
“Before a clinical trial is carried out, the investigators predefine what they are going to measure. This is called the primary outcome and this predetermined experiment is the only one which counts.
“After the trial the investigators can look at and report anything they like as possibly interesting outcomes. These are then secondary outcomes and, if the investigators wish they can subsequently organise another trial where these interesting results are defined as the primary outcome which they hope will pass in this second test. This structure of clinical research is necessary to stop chance lucky results influencing the treatments patients get. Positive secondary outcomes are notoriously unreliable and don’t replicate in future studies.
“This trial failed its primary outcome.
“Some secondary outcomes look positive but this is frequently the case for these secondary analyses.
“The paper is clear in saying more work is needed. It is. We now need a second trial with a primary outcome defined from the apparent positives in this failed trial.”
Prof. Tara Spires-Jones, UK Dementia Research Institute Programme Lead and Deputy Director, Centre for Discovery Brain Sciences, University of Edinburgh, said:
“This study tested whether a nutritional drink could help symptoms in people in the very early stages of Alzheimer’s disease. This study is important because we urgently need a better understanding of how to prevent or treat Alzheimer’s disease. Unfortunately, the treatment did not improve the specific memory and thinking tests that were the primary outcome of the study, nor did it decrease the chances of progressing to full dementia symptoms. Some of the other tests of brain structure and function were promising, but overall this study indicates that a specific change in nutrition is unlikely to make a large difference to people with Alzheimer’s, even in the early stages. There is strong evidence that a healthy lifestyle including exercise and a healthy diet can help reduce risk for developing dementia, but once the brain damage starts, a dietary intervention is unlikely to stop the disease.
Dr Elizabeth Coulthard, Consultant Senior Lecturer in Dementia Neurology, University of Bristol, said:
“Results suggest that dietary supplementation with Fortasyn Connect appears to be safe and probably warrants further investigation. However, the data are not strong enough to advocate use of this dietary supplement. It is important that these results are not overblown because Fortasyn Connect can be bought in the form of Souvenaid and the cost is high. So, people may incur expense without really knowing if there is a benefit.
“Dementia research is hampered by repeated studies that do not give clear results. Better measures to monitor how drugs or dietary supplements affect people are required.”
Dr David Reynolds, Chief Scientific Officer at Alzheimer’s Research UK said:
“While taking this drink won’t do people any harm, there is mixed evidence of possible benefits and this study did not reveal the effects on memory and thinking that the researchers were hoping to measure.
“As this was a relatively small study, it is difficult to detect signs of a robust effect or to draw any firm conclusions from the results. Larger studies will need to investigate whether the effects of the drink are just too small to robustly measure or whether our tools for assessing benefits so early in the disease are not sensitive enough to properly determine its value.
“Although this, and previous studies of Souvenaid, have suggested some benefits for memory and brain function, these haven’t played out into consistent benefits for patients and it’s important to understand why. While studies of Souvenaid in people with mid-stage Alzheimer’s have been mixed, this study doesn’t show evidence that the drink slows the progression of the disease in those at the very early stages.
“Maintaining a healthy, nutritionally balanced diet can play an important role in keeping dementia risk as low as possible. Not smoking, keeping blood pressure and cholesterol in check, only drinking in moderation, and stay mentally and physically active can also help to maintain a healthy brain as we get older.
“If people are worried about their memory, or are considering buying and taking Souvenaid as a supplement to manage their diet then it is important that they discuss this with their GP.”
* ‘24-month intervention with a specific multinutrient in people with prodromal Alzheimer’s disease (LipiDiDiet): a randomised, double-blind, controlled trial’ by Hilkka Soininen et al. published in the Lancet Neurology on Monday 30 October 2017.
Prof. Robert Howard: “I have received funding from the MRC, Alzheimer’s Society and NIHR for the conduct of independent clinical trials in dementia and psychosis in older people.”
Prof. John Hardy: “John Hardy consults for Ceracuity.”
Prof. Tara Spires-Jones: “I am employed by the University of Edinburgh and am a member of the Grant Review Board for Alzheimer’s Research UK.”
None others received.