Evidence map›Paper›PMID 28381516›Full record

ArticleNeurology2017

Randomized controlled trials in mild cognitive impairment: Sources of variability.

Ronald C Petersen, Ronald G Thomas, Paul S Aisen, Richard C Mohs, Maria C Carrillo, Marilyn S Albert, Alzheimer's Disease Neuroimaging Initiative (ADNI) and Foundation for NIH (FNIH) Biomarkers Consortium AD MCI Placebo Data Analysis Project Team

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In one paragraph

Article in Neurology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing 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.

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

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

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Article
  7. Review
  8. Alzheimer disease.Nature reviews. Disease primers · 2021
    Review
  9. Article
  10. Article
  11. Article
  12. Article
  13. Immunotherapies for Aging-Related Neurodegenerative Diseases-Emerging Perspectives and New Targets.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2020
    Review
  14. Article
  15. Article
  16. Article
  17. Article
  18. Detection of Rater Errors on Cognitive Instruments in a Clinical Trial Setting.The journal of prevention of Alzheimer's disease · 2018
    Article
  19. Geographic Clusters of Alzheimer's Disease Mortality Rates in the USA: 2008-2012.The journal of prevention of Alzheimer's disease · 2018
    Article
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors.

Ronald C PetersenFrom the Department of Neurology (R.C.P.), Mayo Clinic College of Medicine, Rochester, MN; Department of Neurosciences (R.G.T.), University of California, San Diego, La Jolla; University of Southern California (P.S.A.), Los Angeles; Eli Lilly and Company (R.C.M.), Indianapolis, IN; Division of Medical & Scientific Relations (M.C.C.), Alzheimer's Association, Chicago, IL; and Johns Hopkins School of Medicine (M.S.A.), Baltimore, MD. R.C.M. is currently with Global Alzheimer's Platform Foundation, Washington, DC. peter8@mayo.edu.
Ronald G ThomasFrom the Department of Neurology (R.C.P.), Mayo Clinic College of Medicine, Rochester, MN; Department of Neurosciences (R.G.T.), University of California, San Diego, La Jolla; University of Southern California (P.S.A.), Los Angeles; Eli Lilly and Company (R.C.M.), Indianapolis, IN; Division of Medical & Scientific Relations (M.C.C.), Alzheimer's Association, Chicago, IL; and Johns Hopkins School of Medicine (M.S.A.), Baltimore, MD. R.C.M. is currently with Global Alzheimer's Platform Foundation, Washington, DC.
Paul S AisenFrom the Department of Neurology (R.C.P.), Mayo Clinic College of Medicine, Rochester, MN; Department of Neurosciences (R.G.T.), University of California, San Diego, La Jolla; University of Southern California (P.S.A.), Los Angeles; Eli Lilly and Company (R.C.M.), Indianapolis, IN; Division of Medical & Scientific Relations (M.C.C.), Alzheimer's Association, Chicago, IL; and Johns Hopkins School of Medicine (M.S.A.), Baltimore, MD. R.C.M. is currently with Global Alzheimer's Platform Foundation, Washington, DC.
Richard C MohsFrom the Department of Neurology (R.C.P.), Mayo Clinic College of Medicine, Rochester, MN; Department of Neurosciences (R.G.T.), University of California, San Diego, La Jolla; University of Southern California (P.S.A.), Los Angeles; Eli Lilly and Company (R.C.M.), Indianapolis, IN; Division of Medical & Scientific Relations (M.C.C.), Alzheimer's Association, Chicago, IL; and Johns Hopkins School of Medicine (M.S.A.), Baltimore, MD. R.C.M. is currently with Global Alzheimer's Platform Foundation, Washington, DC.
Maria C CarrilloFrom the Department of Neurology (R.C.P.), Mayo Clinic College of Medicine, Rochester, MN; Department of Neurosciences (R.G.T.), University of California, San Diego, La Jolla; University of Southern California (P.S.A.), Los Angeles; Eli Lilly and Company (R.C.M.), Indianapolis, IN; Division of Medical & Scientific Relations (M.C.C.), Alzheimer's Association, Chicago, IL; and Johns Hopkins School of Medicine (M.S.A.), Baltimore, MD. R.C.M. is currently with Global Alzheimer's Platform Foundation, Washington, DC.
Marilyn S AlbertFrom the Department of Neurology (R.C.P.), Mayo Clinic College of Medicine, Rochester, MN; Department of Neurosciences (R.G.T.), University of California, San Diego, La Jolla; University of Southern California (P.S.A.), Los Angeles; Eli Lilly and Company (R.C.M.), Indianapolis, IN; Division of Medical & Scientific Relations (M.C.C.), Alzheimer's Association, Chicago, IL; and Johns Hopkins School of Medicine (M.S.A.), Baltimore, MD. R.C.M. is currently with Global Alzheimer's Platform Foundation, Washington, DC.
Alzheimer's Disease Neuroimaging Initiative (ADNI) and Foundation for NIH (FNIH) Biomarkers Consortium AD MCI Placebo Data Analysis Project Team

Funding

Alzheimer's Disease Neuroimaging Initiative - SupplementU01AG024904 · NIA · NORTHERN CALIFORNIA INSTITUTE RES &EDUC · PI WEINER, MICHAEL W · 2004 to 2015
$121.0M
Project 2 MeasurementU19AG033655 · NIA · JOHNS HOPKINS UNIVERSITY · PI Abhay Moghekar · 2014 to 2026
$51.5M
SUPPLEMENT TO ALZHEIMERS DISEASE PATIENT REGISTRYU01AG006786 · NIA · MAYO CLINIC ROCHESTER · PI GRAFF-RADFORD, JONATHAN, JACK, CLIFFORD R. · 1986 to 2023
$49.6M
'T V ASSESSMENT - MEMORY DISORDERED PATIENTS'P50AG005146 · NIA · JOHNS HOPKINS UNIVERSITY · PI HUGANIR, RICHARD L · 1985 to 2019
$37.6M
THE PGRN/TDP-43 AXIS IN ALZHEIMER?S DISEASE AND NEURODEGENERATIONP50AG016574 · NIA · MAYO CLINIC ROCHESTER · PI BU, GUOJUN · 1999 to 2018
$36.9M
Research Training in Age-Related Cognitive DisordersT32AG027668 · NIA · JOHNS HOPKINS UNIVERSITY · PI MARILYN S. ALBERT · 2007 to 2026
$6.3M
NIA NIH HHS P50 AG005146NIA NIH HHS P50 AG016574NIA NIH HHS T32 AG027668NIA NIH HHS U01 AG006786NIA NIH HHS U01 AG024904NIA NIH HHS U19 AG033655
6 · The paper itself

Abstract

objectiveTo examine the variability in performance among placebo groups in randomized controlled trials for mild cognitive impairment (MCI).

methodsPlacebo group data were obtained from 2 National Institute on Aging (NIA) MCI randomized controlled trials, the Alzheimer's Disease Cooperative Study (ADCS) MCI trial and the Alzheimer's Disease Neuroimaging Initiative (ADNI), which is a simulated clinical trial, in addition to industry-sponsored clinical trials involving rivastigmine, galantamine, rofecoxib, and donepezil. The data were collated for common measurement instruments. The performance of the placebo participants from these studies was tracked on the Alzheimer's Disease Assessment Scale-cognitive subscale, Mini-Mental State Examination, and Clinical Dementia Rating-sum of boxes, and for progression on these measures to prespecified clinical study endpoints.

resultsThe progression to clinical endpoints varied a great deal among the trials. The expected performances were seen for the participants in the 2 NIA trials, ADCS and ADNI, with generally worsening of performance over time; however, the industry-sponsored trials largely showed stable or improved performance in their placebo participants.

conclusionsIn spite of apparently similar criteria for MCI being adopted by the 7 studies, the implementation of the criteria varied a great deal. Several explanations including instruments used to characterize participants and variability among study populations contributed to the findings.

Indexed as

Randomized Controlled Trials as TopicAgedAlzheimer DiseaseApolipoprotein E4Cognitive DysfunctionDisease ProgressionFemaleHumansMaleMental Status ScheduleNootropic AgentsPatient SelectionPlacebosSeverity of Illness IndexApolipoprotein E4Nootropic AgentsPlacebos

Identifiers

PMID28381516
PMCPMC5409843

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.