Evidence map›Paper›PMID 29097166›Full record

Trial reportThe Lancet. Neurology2017

24-month intervention with a specific multinutrient in people with prodromal Alzheimer's disease (LipiDiDiet): a randomised, double-blind, controlled trial.

Hilkka Soininen, Alina Solomon, Pieter Jelle Visser, Suzanne B Hendrix, Kaj Blennow, Miia Kivipelto, Tobias Hartmann, LipiDiDiet clinical study group

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Lancet. Neurology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 114 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
114citing papers in PubMed, 11 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

114 citing papers in PubMed, 11 syntheses or guidelines pooled it.

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  8. Souvenaid for Alzheimer's disease.The Cochrane database of systematic reviews · 2020
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54 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors.

Hilkka SoininenDepartment of Neurology, Institute of Clinical Medicine, University of Eastern Finland, Kuopio, Finland; Neurocenter, Department of Neurology, Kuopio University Hospital, Kuopio, Finland. Electronic address: hilkka.soininen@uef.fi.
Alina SolomonDepartment of Neurology, Institute of Clinical Medicine, University of Eastern Finland, Kuopio, Finland; Department of Clinical Geriatrics, Department of Neurobiology, Care Sciences and Society, Karolinska Institute, Huddinge, Sweden; Clinical Trials Unit, Department of Geriatric Medicine, Karolinska University Hospital, Huddinge, Sweden.
Pieter Jelle VisserDepartment of Psychiatry and Neuropsychology, Alzheimer Center Limburg, University of Maastricht, Maastricht, Netherlands; Department of Neurology, Alzheimer Center, Amsterdam Neuroscience, VU University Medical Center, Amsterdam, Netherlands.
Suzanne B HendrixPentara Corporation, Salt Lake City, UT, USA.
Kaj BlennowDepartment of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, The Sahlgrenska Academy at University of Gothenburg, Mölndal, Sweden; Clinical Neurochemistry Laboratory, Sahlgrenska University Hospital, Mölndal, Sweden.
Miia KivipeltoDepartment of Neurology, Institute of Clinical Medicine, University of Eastern Finland, Kuopio, Finland; Department of Clinical Geriatrics, Department of Neurobiology, Care Sciences and Society, Karolinska Institute, Huddinge, Sweden; Clinical Trials Unit, Department of Geriatric Medicine, Karolinska University Hospital, Huddinge, Sweden.
Tobias HartmannGerman Institute for Dementia Prevention (DIDP), Medical Faculty, and Department of Experimental Neurology, Saarland University, Homburg, Germany.
LipiDiDiet clinical study group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNutrition 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.

Indexed as

Outcome Assessment, Health CareProdromal SymptomsAgedAged, 80 and overAlzheimer DiseaseDocosahexaenoic AcidsDouble-Blind MethodEicosapentaenoic AcidFemaleHumansMaleMiddle AgedPhospholipidsDocosahexaenoic AcidsEicosapentaenoic AcidFortasyn ConnectPhospholipids

Identifiers

PMID29097166
PMCPMC5697936

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.