Evidence map›Paper›PMID 27662307›Full record

ReviewJournal of Alzheimer's disease : JAD2017

Cerebrospinal Fluid Biomarkers for Alzheimer's Disease: A View of the Regulatory Science Qualification Landscape from the Coalition Against Major Diseases CSF Biomarker Team.

Stephen P Arnerić, Richard Batrla-Utermann, Laurel Beckett, Tobias Bittner, Kaj Blennow, Leslie Carter, Robert Dean, Sebastiaan Engelborghs, Just Genius, Mark Forrest Gordon and 14 more

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review 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. Cited by 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed
–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. Review
  2. Article
  3. Review
  4. Plasma protein risk scores for mild cognitive impairment and Alzheimer's disease in the Framingham heart study.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025
    Article
  5. Article
  6. Article
  7. Article
  8. Review
  9. Review
  10. Review
  11. Review
  12. Article
  13. Review
  14. New directions in clinical trials for frontotemporal lobar degeneration: Methods and outcome measures.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2020
    Article
  15. Review
  16. Observational
  17. Review
  18. Review
  19. Review
  20. Review
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

24 authors.

Stephen P ArnerićCritical Path Institute, Coalition Against Major Diseases, Tucson, AZ, USA.
Richard Batrla-UtermannRoche Diagnostics, Basel, Switzerland.
Laurel BeckettUniversity of California, Davis, CA, USA.
Tobias BittnerRoche Diagnostics, Basel, Switzerland.
Kaj BlennowClinical Neurochemistry Lab, Institute of Neuroscience and Physiology, The Sahlgrenska Academy at University of Gothenburg, Sahlgrenska University Hospital, Mölndal, Sweden.
Leslie CarterAbbVie, Abbott Park, IL, USA.
Robert DeanEli Lilly and Company, Indianapolis, IN, USA.
Sebastiaan EngelborghsReference Center for Biological Markers of Dementia (BIODEM), University of Antwerp, Antwerp, Belgium.
Just GeniusAbbVie, Abbott Park, IL, USA.
Mark Forrest GordonBoehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.
Janice HitchcockEli Lilly and Company, Indianapolis, IN, USA.
June KaplowEisai, Woodcliff Lake, NJ, USA.
Johan LuthmanEisai, Woodcliff Lake, NJ, USA.
Richard MeibachNovartis, East Hanover, NJ, USA.
David RaunigIcon, Warrington, PA, USA.
Klaus RomeroCritical Path Institute, Coalition Against Major Diseases, Tucson, AZ, USA.
Mahesh N SamtaniJanssen R&D, Raritan, NJ, USA.
Mary SavageMerck, Rahway, NJ, USA.
Leslie ShawUniversity of Pennsylvania, Philadelphia, PA, USA.
Diane StephensonCritical Path Institute, Coalition Against Major Diseases, Tucson, AZ, USA.
Robert M UmekMeso Scale Diagnostics, LLC, Rockville, MD, USA.
Hugo VandersticheleBiomarkable, Gent, Belgium.
Brian WillisEli Lilly and Company, Indianapolis, IN, USA.
Susan YuleGenentech/Roche, San Francisco, CA, USA.

Funding

UC Davis Alzheimer's Disease Core CenterP30AG010129 · NIA · UNIVERSITY OF CALIFORNIA DAVIS · PI DECARLI, CHARLES · 1991 to 2020
$28.3M
Critical Path InstituteU01FD003865 · FDA · CRITICAL PATH INSTITUTE · PI BRUMFIELD, MARTHA A · 2009 to 2013
$9.8M
FDA HHS U01 FD003865NIA NIH HHS P30 AG010129
6 · The paper itself

Abstract

Alzheimer's disease (AD) drug development is burdened with the current requirement to conduct large, lengthy, and costly trials to overcome uncertainty in patient progression and effect size on treatment outcome measures. There is an urgent need for the discovery, development, and implementation of novel, objectively measured biomarkers for AD that would aid selection of the appropriate subpopulation of patients in clinical trials, and presumably, improve the likelihood of successfully evaluating innovative treatment options. Amyloid deposition and tau in the brain, which are most commonly assessed either in cerebrospinal fluid (CSF) or by molecular imaging, are consistently and widely accepted. Nonetheless, a clear gap still exists in the accurate identification of subjects that truly have the hallmarks of AD. The Coalition Against Major Diseases (CAMD), one of 12 consortia of the Critical Path Institute (C-Path), aims to streamline drug development for AD and related dementias by advancing regulatory approved drug development tools for clinical trials through precompetitive data sharing and adoption of consensus clinical data standards. This report focuses on the regulatory process for biomarker qualification, briefly comments on how it contrasts with approval or clearance of companion diagnostics, details the qualifications currently available to the field of AD, and highlights the current challenges facing the landscape of CSF biomarkers qualified as hallmarks of AD. Finally, it recommends actions to accelerate regulatory qualification of CSF biomarkers that would, in turn, improve the efficiency of AD therapeutic development.

Indexed as

Alzheimer DiseaseBiomarkersClinical Trials as TopicDrug ApprovalDrug DiscoveryHumansBiomarkersAlzheimer’s diseasebiomarker qualificationcerebrospinal fluid biomarkersCoalition Against Major Diseases

Identifiers

PMID27662307
PMCPMC5115607

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

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.