Evidence map›Paper›PMID 38023620›Full record

ArticleAlzheimer's & dementia (New York, N. Y.)

Operationalizing selection criteria for clinical trials in Alzheimer's disease: Biomarker and clinical considerations.

Ronald C Petersen, Ana Graf, Chris Brady, Susan De Santi, Hana Florian, Jaren Landen, Mike Pontecorvo, Christopher Randolph, Kaycee M Sink, Maria C Carrillo and 1 more

Abstract read
In one paragraph

Article in Alzheimer's & dementia (New York, N. Y.). The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. 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.

Ronald C PetersenDepartment of Neurology Mayo Clinic Rochester Minnesota USA.
Ana GrafNovartis Pharma AG Basel Switzerland.
Chris BradyWCG Clinical Endpoint Solutions, Princeton New Jersey USA.
Susan De SantiNeurology Business Group Eisai Nutley New Jersey USA.
Hana FlorianAbbvie North Chicago Illinois USA.
Jaren LandenBiogen Cambridge Massachusetts USA.
Mike PontecorvoEli Lilly and Company Indianapolis Indiana USA.
Christopher RandolphWCG Clinical Endpoint Solutions, Princeton New Jersey USA.
Kaycee M SinkGenentech Inc. South San Francisco California USA.
Maria C CarrilloAlzheimer's Association Chicago Illinois USA.
Christopher J WeberAlzheimer's Association Chicago Illinois USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Alzheimer's disease (AD) staging criteria lack standardized, empirical description. Well-defined AD staging criteria are an important consideration in protocol design, influencing a more standardized inclusion/exclusion criteria and defining what constitutes meaningful differentiation among the stages. However, many trials are being designed on the basis of biomarker features and the two need to be coordinated. The Alzheimer's Association Research Roundtable (AARR) Spring 2021 meeting discussed the implementation of preclinical AD staging criteria, and provided recommendations for how they may best be incorporated into clinical trials research. Discussion also included what currently available tools for global clinical trials may best define populations in preclinical AD trials, and if are we able to differentiate preclinical from clinical stages of the disease. Well-defined AD staging criteria are key to improving early detection, diagnostics, clinical trial enrollment, and identifying statistically significant clinical changes, and researchers discussed how emerging blood biomarkers may help with more efficient screening in preclinical stages.

Indexed as

Alzheimer's diseaseamyloidbiomarkersclinical trialscognitioncognitive impairmentdementiamild cognitive impairmenttau

Identifiers

PMID38023620
PMCPMC10655199

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.