Evidence map›Paper›PMID 32417770›Full record

ArticleJournal of Alzheimer's disease : JAD2020

The MARBLE Study Protocol: Modulating ApoE Signaling to Reduce Brain Inflammation, DeLirium, and PostopErative Cognitive Dysfunction.

Keith W VanDusen, Sarada Eleswarpu, Eugene W Moretti, Michael J Devinney, Donna M Crabtree, Daniel T Laskowitz, Marty G Woldorff, Kenneth C Roberts, John Whittle, Jeffrey N Browndyke and 9 more

Open access · greenAbstract readClinical Trial Protocol
In one paragraph

Article in Journal of Alzheimer's disease : JAD, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 18% of its field
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

18 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.

  1. Pooled it
  2. Trial
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  7. Observational
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  9. Review
  10. ApoE Mimetic Peptides as Therapy for Traumatic Brain Injury.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2023
    Review
  11. A Real-Time Neurophysiologic Stress Test for the Aging Brain: Novel Perioperative and ICU Applications of EEG in Older Surgical Patients.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2023
    Review
  12. Review
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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

19 authors at 4 institutions in 1 country.

Keith W VanDusenDepartment of Anesthesiology, Duke University, Durham, NC, USA.
Sarada EleswarpuDepartment of Anesthesiology, Duke University, Durham, NC, USA.
Eugene W MorettiDepartment of Anesthesiology, Duke University, Durham, NC, USA.
Michael J DevinneyDepartment of Anesthesiology, Duke University, Durham, NC, USA.
Donna M CrabtreeDuke Office of Clinical Research, Duke University, Durham, NC, USA.
Daniel T LaskowitzDepartment of Neurology, Duke University, Durham, NC, USA.
Marty G WoldorffDepartment of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.
Kenneth C RobertsCenter for Cognitive Neuroscience, Duke University Medical Center, Durham, NC, USA.
John WhittleDepartment of Anesthesiology, Duke University, Durham, NC, USA.
Jeffrey N BrowndykeDepartment of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.
Mary CooterDepartment of Anesthesiology, Duke University, Durham, NC, USA.
Frank W RockholdDuke Clinical Research Institute, Durham, NC, USA.
Oke AnakwenzeDepartment of Orthopaedic Surgery, Duke University, Durham, NC, USA.
Michael P BolognesiDepartment of Orthopaedic Surgery, Duke University, Durham, NC, USA.
Mark E EasleyDepartment of Orthopaedic Surgery, Duke University, Durham, NC, USA.
Michael N FerrandinoDepartment of Surgery, Duke University, Durham, NC, USA.
William A JiranekDepartment of Surgery, Duke University, Durham, NC, USA.
Miles BergerDepartment of Anesthesiology, Duke University, Durham, NC, USA.
MARBLE Study Investigators
Duke University · USDuke University Hospital · USDuke Medical Center · USClinical Research Institute · US

Funding

Resource Core 3 - Metabolomics CoreP30AG028716 · NIA · DUKE UNIVERSITY · PI Sarah B. Peskoe · 2006 to 2026
$24.6M
A Systems Biology Approach to HIV-associated Neurocognitive Impairment: Role of Drug Abuse and NeuroinflammationR01DA043241 · NIDA · DUKE UNIVERSITY · PI MEADE, CHRISTINA S, MURDOCH, DAVID MARTIN · 2016 to 2020
$3.4M
Physical Resiliencies: Indicators and Mechanisms in the Elderly CollaborativeUH2AG056925 · NIA · DUKE UNIVERSITY · PI COLON-EMERIC, CATHLEEN S, WHITSON, HEATHER E. · 2017 to 2018
$2.0M
Neuro-inflammation in Postoperative Cognitive Dysfunction: CSF and fMRI StudiesK76AG057022 · NIA · DUKE UNIVERSITY · PI BERGER, MILES · 2017 to 2022
$1.4M
NIA NIH HHS K76 AG057022NIA NIH HHS P30 AG028716NIA NIH HHS UH2 AG056925NIDA NIH HHS R01 DA043241
6 · The paper itself

Abstract

backgroundPerioperative neurocognitive disorders (PND) are common complications in older adults associated with increased 1-year mortality and long-term cognitive decline. One risk factor for worsened long-term postoperative cognitive trajectory is the Alzheimer's disease (AD) genetic risk factor APOE4. APOE4 is thought to elevate AD risk partly by increasing neuroinflammation, which is also a theorized mechanism for PND. Yet, it is unclear whether modulating apoE4 protein signaling in older surgical patients would reduce PND risk or severity.

objectiveMARBLE is a randomized, blinded, placebo-controlled phase II sequential dose escalation trial designed to evaluate perioperative administration of an apoE mimetic peptide drug, CN-105, in older adults (age≥60 years). The primary aim is evaluating the safety of CN-105 administration, as measured by adverse event rates in CN-105 versus placebo-treated patients. Secondary aims include assessing perioperative CN-105 administration feasibility and its efficacy for reducing postoperative neuroinflammation and PND severity.

methods201 patients undergoing non-cardiac, non-neurological surgery will be randomized to control or CN-105 treatment groups and receive placebo or drug before and every six hours after surgery, for up to three days after surgery. Chart reviews, pre- and postoperative cognitive testing, delirium screening, and blood and CSF analyses will be performed to examine effects of CN-105 on perioperative adverse event rates, cognition, and neuroinflammation. Trial results will be disseminated by presentations at conferences and peer-reviewed publications.

conclusionMARBLE is a transdisciplinary study designed to measure CN-105 safety and efficacy for preventing PND in older adults and to provide insight into the pathogenesis of these geriatric syndromes.

Indexed as

Anti-Inflammatory Agents, Non-SteroidalApolipoproteins ENeuroprotective AgentsPostoperative Cognitive ComplicationsBiomimetic MaterialsClinical Trials, Phase II as TopicDeliriumEncephalitisHumansRandomized Controlled Trials as TopicTreatment OutcomeAnti-Inflammatory Agents, Non-SteroidalApoE protein, humanApolipoproteins ENeuroprotective AgentsAlzheimer’s diseaseApolipoprotein EApolipoprotein E4deliriuminflammationneurocognitive disorderssurgery

Identifiers

PMID32417770
PMCPMC7923142
OpenAlexW3024114712

What OpenQuestion holds

Textmetadata
LicenceTDM
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.