The use of a specifically formulated multinutrient drink in early Alzheimer’s disease slows down the deterioration of memory and cognitive functions as well as whole brain atrophy associated with the disease, a new study shows. The three-year results from the European LipiDiDiet trial were published in Alzheimer’s & Dementia: The Journal of the Alzheimer's Association and presented in CTAD2020 Congress on 5 November. This is the longest randomized clinical trial in prodromal Alzheimer’s disease (AD) with a positive outcome ever conducted.
At baseline, the participants of the randomized, double-blind, controlled trial were free of dementia but showed first signs of a slight memory impairment and had biomarker evidence (e.g. a brain scan or amyloid levels) for underlying AD pathology. 311 of 382 participants screened were randomly assigned to daily use of the multinutrient drink or a placebo drink of the same volume, taste, texture and appearance. Neither patients, doctors nor scientists knew who was given the placebo or the multinutrient drink. Patients from 11 centres in Finland, the Netherlands, Sweden and Germany were involved in the multicentre trial. The researchers investigated the effects of the intervention on cognition, memory, brain atrophy and related measures.
Prodromal AD patients are on the ultimate stage just before progressing to dementia. These patients, and their close partners, already realize that the mind deteriorates and memory, especially short-term memory, slowly but progressively fades. There is no cure and no treatment available for prodromal Alzheimer’s disease. However, this early Alzheimer’s disease stage is considered to represent the best option for intervention. The LipiDiDiet consortium has previously shown that the treatment consisting of a daily multinutrient drink could help to stabilize functioning in everyday life and would help to slow shrinking of some parts of the brain. However, it remained inconclusive how well this effect would spread to certain cognitive items like memory and cognition, or whether it would slow the decay of the brain as a whole or only of some parts of it.
In the new work, the trial participants were followed for up to three years of intervention, in order to study whether with this longer treatment time, the effect of the nutrition-based intervention on the disease progression might become more clearly evident. The new results indeed show, that this is the case. The treatment showed significant effects on memory, and other cognitive aspects and was also observed to slow whole brain atrophy. Unexpectedly it was also found that effects actually increased and expanded over the treatment time.
Currently, there is no treatment to cure Alzheimer’s disease. However, the present study reports the best effect sizes thus far known for people with prodromal AD treatment.
“This is especially remarkable considering that this treatment is built entirely on a specific formulation of nutritional components. The positive effects of the treatment were most pronounced in those patients who began taking the multinutrient formulation at the earliest prodromal stage of Alzheimer’s disease, and these positive effects increased the longer the treatment continued,” says Professor Hilkka Soininen from the University of Eastern Finland. Professor Soininen was the work package leader of the clinical trial.
The multinutrient drink used in the study contains Fortasyn Connect, a formulation designed for the dietary management of early Alzheimer’s disease, consisting of docosahexaenoic acid and eicosapentaenoic acid, uridine monophosphate, choline, vitamins B12, B6, C, E, and folic acid, phospholipids, and selenium. The intervention was well tolerated and has a good safety profile. Previous preclinical research has shown that this specific combination of nutrients reduces a range of key AD-linked brain pathologies in a neuroprotective manner, and previous clinical studies showed benefits on memory and EEG measures of functional connectivity in patients with mild dementia. A commercial variant, Souvenaid, is globally marketed by Nutricia company.
LipiDiDiet is a large European research consortium, founded in 1999 originally under the name LipiDiet, conducting basic, epidemiological and clinical research aiming to investigate the therapeutic and preventive impact of nutritional lipids on neuronal and cognitive performance in aging, Alzheimer’s disease and Vascular dementia. LipiDiDiet is coordinated by Tobias Hartmann from Saarland University, Germany. LipiDiDiet work is largely funded by the European Union Framework Programmes and the EU Joint Programme – Neurodegenerative Diseases Research.
For further information, please contact:
Professor Emerita Hilkka Soininen, hilkka.soininen (a) uef.fi, +358 40 573 5749
Research Director Merja Hallikainen, merja.hallikainen (a) uef.fi, +358 40 567 8433
Hilkka Soininen, Alina Solomon, Pieter Jelle Visser, Suzanne B Hendrix, Kaj Blennow, Miia Kivipelto & Tobias Hartmann on behalf of the LipiDiDiet clinical study group. 36-month LipiDiDiet multinutrient clinical trial in prodromal Alzheimer’s disease. Alzheimer’s Dement. 2020;1-12. DOI 10/.1002/alz.12172