Evidence map›Paper›PMID 21968871›Full record

Trial reportThe journal of nutrition, health & aging2011

Efficacy of a medical food on cognition in Alzheimer's disease: results from secondary analyses of a randomized, controlled trial.

P J G H Kamphuis, F R J Verhey, M G M Olde Rikkert, J W R Twisk, S H N Swinkels, P Scheltens

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The journal of nutrition, health & aging, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 4 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

16 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
  2. Souvenaid for Alzheimer's disease.The Cochrane database of systematic reviews · 2020
    Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Review
  8. Mediterranean diet, micronutrients and macronutrients, and MRI measures of cortical thickness.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2017
    Article
  9. Review
  10. Nutrition and prevention of Alzheimer's dementia.Frontiers in aging neuroscience · 2014
    Review
  11. Frailty and cognition: linking two common syndromes in older persons.The journal of nutrition, health & aging · 2013
    Article
  12. Review
  13. Article
  14. Article
  15. Article
  16. The multidimentionality of frailty: many faces of one single dice.The journal of nutrition, health & aging · 2011
    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

6 authors.

P J G H KamphuisNutricia Advanced Medical Nutrition, Danone Research, Centre for Specialised Nutrition, Wageningen, The Netherlands.
F R J Verhey
M G M Olde Rikkert
J W R Twisk
S H N Swinkels
P Scheltens

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo investigate the extent that baseline cognitive impairment and intake adherence affected the 13-item Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) intervention response of a medical food in Alzheimer's Disease (AD) patients. DESIGN/SETTING/PARTICIPANTS /INTERVENTION/MEASUREMENTS: This analysis was performed on data from a proof-of-concept study, consisting of a 12-week, double-blind, randomized, controlled, multicenter trial, followed by a similarly designed 12-week extension study. Patients with mild AD (Mini-Mental State Examination [MMSE] score of 20-26) were randomized to receive active or control product as a 125 ml daily drink. One of the co-primary outcome measures was the 13-item ADAS-cog. In this analysis, the study population was divided into two subgroups: patients with 'low' baseline ADAS-cog scores (<25.0) and patients with 'high' baseline ADAS-cog scores (≥25.0). Repeated Measures Models (RMM) were used to determine the relationship between ADAS-cog score and intervention.

resultsA significant treatment effect (F[1,319]=4.0, p=0.046) was shown in patients with 'high' baseline ADAS-cog, but not in patients with 'low' baseline ADAS-cog (F[1,250]=1.25, p=0.265). Overall, intake adherence was significantly correlated with ADAS-cog improvement in the active product group (correlation coefficient=-0.260; p=0.019), but not the control group.

conclusionThese data indicate that baseline ADAS-cog significantly influenced the effect of Souvenaid intervention on ADAS-cog outcome. A higher intake of active study product was also associated with greater cognitive benefit. These findings highlight the potential benefits of Souvenaid in AD patients and warrant confirmation in larger, controlled studies.

Indexed as

Activities of Daily LivingCognitionDietary SupplementsGeriatric AssessmentAgedAged, 80 and overAlzheimer DiseaseDouble-Blind MethodFemaleHumansMaleMicronutrientsPatient ComplianceTreatment OutcomeMicronutrients

Identifiers

PMID21968871
PMCPMC12878925

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

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.