Abstract
SummaryBackgroundNutrition is an important modifiable risk factor in Alzheimer's disease. Previous trials of the multinutrient Fortasyn Connect showed benefits in mild Alzheimer's disease dementia. LipiDiDiet investigated the effects of Fortasyn Connect on cognition and related measures in prodromal Alzheimer's disease. Here, we report the 24-month results of the trial.MethodsLipiDiDiet was a 24-month randomised, controlled, double-blind, parallel-group, multicentre trial (11 sites in Finland, Germany, the Netherlands, and Sweden), with optional 12-month double-blind extensions. The trial enrolled individuals with prodromal Alzheimer's disease, defined according to the International Working Group (IWG)-1 criteria. Participants were randomly assigned (1:1) to active product (125 mL once-a-day drink containing Fortasyn Connect) or control product. Randomisation was computer-generated centrally in blocks of four, stratified by site. All study personnel and participants were masked to treatment assignment. The primary endpoint was change in a neuropsychological test battery (NTB) score. Analysis was by modified intention to treat. Safety analyses included all participants who consumed at least one study product dose. This trial is registered with the Dutch Trial Register, number NTR1705.FindingsBetween April 20, 2009, and July 3, 2013, 311 of 382 participants screened were randomly assigned to the active group (n=153) or control group (n=158). Mean change in NTB primary endpoint was −0·028 (SD 0·453) in the active group and −0·108 (0·528) in the control group; estimated mean treatment difference was 0·098 (95% CI −0·041 to 0·237; p=0·166). The decline in the control group was less than the prestudy estimate of −0·4 during 24 months. 66 (21%) participants dropped out of the study. Serious adverse events occurred in 34 (22%) participants in the active group and 30 (19%) in control group (p=0·487), none of which were regarded as related to the study intervention.InterpretationThe 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, rendering the primary endpoint inadequately powered. Group differences on secondary endpoints of disease progression measuring cognition and function and hippocampal atrophy 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.FundingEuropean Commission 7th Framework Programme.
Highlights
The course of Alzheimer’s disease is characterised by progressive accumulation of neuropathology over decades
We excluded participants with dementia according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV); historical use of donepezil, rivastigmine, galantamine, or memantine, use of omega-3 preparations, alcohol or drug abuse, major depressive disorders (DSMIV) or other concomitant serious conditions, intake of vitamins B6, B12, folic acid, vitamin C, or vitamin E of more than 200% of the recommended daily intake, those who participated in any other clinical trial in the last 30 days, and with an MRI or CT scan consistent with a diagnosis of stroke, intracranial bleeding, mass lesion, or normal pressure hydrocephalus
Outcomes The primary efficacy endpoint was the change over 24 months in a composite score of cognitive performance based on a neuropsychological test battery (NTB; appendix),[29] assessed by study neuropsychologists at each site at baseline and months 6, 12, and 24
Summary
Nutrition is an important modifiable risk factor in Alzheimer’s disease. Previous trials of the multinutrient Fortasyn Connect showed benefits in mild Alzheimer’s disease dementia. LipiDiDiet investigated the effects of Fortasyn Connect on cognition and related measures in prodromal Alzheimer’s disease. We report the 24-month results of the trial
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