Evidence map›Paper›PMID 32920957›Full record

Trial reportAlzheimer's & dementia : the journal of the Alzheimer's Association2021

36-month LipiDiDiet multinutrient clinical trial in prodromal Alzheimer's disease.

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

Erratum issuedAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Alzheimer's & dementia : the journal of the Alzheimer's Association, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 70 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
70citing papers in PubMed, 6 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

70 citing papers in PubMed, 6 syntheses or guidelines pooled it.

  1. Pooled it
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  7. Trial
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  14. 36-month LipiDiDiet multinutrient clinical trial in prodromal Alzheimer's disease.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2021
    Trial
  15. Review
  16. Review
  17. Predicting Future Brain Atrophy Based on Longitudinal MRI.medRxiv : the preprint server for health sciences · 2025
    Article
  18. Review
  19. Real-world brain imaging in a population-based cohort enables accurate markers for dementia.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025
    Article
  20. Review

10 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.
Alina SolomonDepartment of Neurology, Institute of Clinical Medicine, University of Eastern Finland, Kuopio, Finland.
Pieter Jelle VisserDepartment of Neurology, Alzheimer Center, Amsterdam Neuroscience, VU University Medical Center, Amsterdam, the Netherlands.
Suzanne B HendrixPentara Corporation, Millcreek, Utah, USA.
Kaj BlennowDepartment of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, The Sahlgrenska Academy at University of Gothenburg, Mölndal, Sweden.
Miia KivipeltoDepartment of Neurology, Institute of Clinical Medicine, University of Eastern Finland, Kuopio, Finland.
Tobias HartmannDeutsches Institut für Demenz Prävention (DIDP), Medical Faculty, Saarland University, Kirrbergerstraße, Homburg, Germany.
LipiDiDiet clinical study group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe LipiDiDiet trial investigates the effects of the specific multinutrient combination Fortasyn Connect on cognition and related measures in prodromal Alzheimer's disease (AD). Based on previous results we hypothesized that benefits increase with long-term intervention.

methodsIn this randomized, double-blind, placebo-controlled trial, 311 people with prodromal AD were recruited using the International Working Group-1 criteria and assigned to active product (125 mL once-a-day drink) or an isocaloric, same tasting, placebo control drink. Main outcome was change in cognition (Neuropsychological Test Battery [NTB] 5-item composite). Analyses were by modified intention-to-treat, excluding (ie, censoring) data collected after the start of open-label active product and/or AD medication.

resultsOf the 382 assessed for eligibility, 311 were randomized, of those 162 participants completed the 36-month study, including 81 with 36-month data eligible for efficacy analysis. Over 36 months, significant reductions in decline were observed for the NTB 5-item composite (-60%; between-group difference 0.212 [95% confidence interval: 0.044 to 0.380]; P = 0.014), Clinical Dementia Rating-Sum of Boxes (-45%; P = 0.014), memory (-76%; P = 0.008), and brain atrophy measures; small to medium Cohen's d effect size (0.25-0.31) similar to established clinically relevant AD treatment. DISCUSSION: This multinutrient intervention slowed decline on clinical and other measures related to cognition, function, brain atrophy, and disease progression. These results indicate that intervention benefits increased with long-term use.

Indexed as

Prodromal SymptomsAgedAged, 80 and overAlzheimer DiseaseAtrophyCognitionCognitive DysfunctionDouble-Blind MethodFemaleHumansMagnetic Resonance ImagingMaleMental Status and Dementia TestsMiddle AgedNeuropsychological TestsNutrition TherapyAlzheimer's diseaseatrophycognitiondietary interventionfunctionhippocampusmild cognitive impairmentnutritionomega 3prodromalrandomized controlled clinical trialtherapy

Identifiers

PMID32920957
PMCPMC7821311

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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.