Evidence map›Paper›PMID 27767993›Full record

Trial reportJournal of Alzheimer's disease : JAD2017

Effect Size Analyses of Souvenaid in Patients with Alzheimer's Disease.

Jeffrey Cummings, Philip Scheltens, Ian McKeith, Rafael Blesa, John E Harrison, Paulo H F Bertolucci, Kenneth Rockwood, David Wilkinson, Wouter Wijker, David A Bennett and 1 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of Alzheimer's disease : JAD, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03249688 (Multimodal Preventive Trial for Alzheimer's Disease), which is not on this map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 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.

NCT03249688 nacompletednot on this map

Multimodal Preventive Trial for Alzheimer's Disease (MIND-ADmini Pilot Trial)

TypeinterventionalSponsorKarolinska InstitutetRan2017 to 2020Enrolled93ConditionsAlzheimer Disease, ProdromalArmsRegular health advice, Multidomain lifestyle, Medical food
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Review
  6. Article
  7. Article
  8. In Pursuit of Healthy Aging: Effects of Nutrition on Brain Function.International journal of molecular sciences · 2021
    Review
  9. Review
  10. Observational
  11. Review
  12. Article
  13. Article
  14. Article
  15. Review
  16. Article
  17. Statistical advances in clinical trials and clinical research.Alzheimer's & dementia (New York, N. Y.) · 2018
    Article
  18. Review
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Jeffrey CummingsCleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, NV, USA.
Philip ScheltensAlzheimer Center and Department of Neurology, Neuroscience Campus Amsterdam, VU University Medical Center, Amsterdam, The Netherlands.
Ian McKeithBiomedical Research Building, Campus for Ageing and Vitality, Newcastle University, Newcastle upon Tyne, UK.
Rafael BlesaDepartment of Neurology, Hospital de la Santa Creu i Sant Pau, Autonomous University of Barcelona, Sant Antoni M. Claret, Barcelona, Spain.
John E HarrisonAlzheimer Center and Department of Neurology, Neuroscience Campus Amsterdam, VU University Medical Center, Amsterdam, The Netherlands.
Paulo H F BertolucciBehaviour Neurology Section - Universidade Federal de São Paulo, São Paulo Sp, Brazil.
Kenneth RockwoodDepartment of Medicine, Dalhousie University, Halifax, NS, Canada.
David WilkinsonMARC, University of Southampton, Southampton, UK.
Wouter WijkerAuxiliis BV, Amsterdam, The Netherlands.
David A BennettDepartment of Neurologic Sciences and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago, IL, USA.
Raj C ShahDepartment of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago, IL, USA.

Funding

Renewal of Centers of Biomedical Research Excellence (COBRE) (Phase 2) CNTN - ResubmissionP20GM109025 · NIGMS · CLEVELAND CLINIC FOUNDATION · PI JESSICA KIRKLAND CALDWELL · 2015 to 2026
$22.8M
NIGMS NIH HHS P20 GM109025
6 · The paper itself

Abstract

backgroundSouvenaid® (uridine monophosphate, docosahexaenoic acid, eicosapentaenoic acid, choline, phospholipids, folic acid, vitamins B12, B6, C, and E, and selenium), was developed to support the formation and function of neuronal membranes.

objectiveTo determine effect sizes observed in clinical trials of Souvenaid and to calculate the number needed to treat to show benefit or harm.

methodsData from all three reported randomized controlled trials of Souvenaid in Alzheimer's disease (AD) dementia (Souvenir I, Souvenir II, and S-Connect) and an open-label extension study were included in analyses of effect size for cognitive, functional, and behavioral outcomes. Effect size was determined by calculating Cohen's d statistic (or Cramér's V method for nominal data), number needed to treat and number needed to harm. Statistical calculations were performed for the intent-to-treat populations.

resultsIn patients with mild AD, effect sizes were 0.21 (95% confidence intervals: -0.06, 0.49) for the primary outcome in Souvenir II (neuropsychological test battery memory z-score) and 0.20 (0.10, 0.34) for the co-primary outcome of Souvenir I (Wechsler memory scale delayed recall). No effect was shown on cognition in patients with mild-to-moderate AD (S-Connect). The number needed to treat (6 and 21 for Souvenir I and II, respectively) and high number needed to harm values indicate a favorable harm:benefit ratio for Souvenaid versus control in patients with mild AD.

conclusionsThe favorable safety profile and impact on outcome measures converge to corroborate the putative mode of action and demonstrate that Souvenaid can achieve clinically detectable effects in patients with early AD.

Indexed as

Functional FoodTreatment OutcomeActivities of Daily LivingAgedAged, 80 and overAlzheimer DiseaseAntipsychotic AgentsDocosahexaenoic AcidsEicosapentaenoic AcidFemaleFollow-Up StudiesHumansMaleMiddle AgedOutcome Assessment, Health CarePsychiatric Status Rating ScalesAntipsychotic AgentsDocosahexaenoic AcidsEicosapentaenoic AcidSeleniumVitaminsAlzheimer’s diseaseeffect sizenumber-needed-to-treatSouvenaid

Identifiers

PMID27767993
PMCPMC5147481

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.