Evidence map›Paper›PMID 40505117›Full record

ArticleJournal of medical Internet research2025

Temporal Dynamics of Subtle Cognitive Change: Validation of a User-Friendly Multidomain Digital Assessment Using an Alcohol Challenge.

John Frederick Dyer, Florentine Marie Barbey, Ayan Ghoshal, Ann Marie Hake, Bryan J Hansen, Md Nurul Islam, Judith Jaeger, Rouba Kozak, Hugh Marston, Mark Moss and 6 more

Abstract readValidation Study
In one paragraph

Article in Journal of medical Internet research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0cells of the map it votes in
0citing papers in PubMed
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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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

16 authors.

John Frederick DyerCumulus Neuroscience, Belfast, United Kingdom.ORCID 0000-0001-9354-6843
Florentine Marie BarbeyCumulus Neuroscience, Dublin, Ireland.ORCID 0000-0003-1162-0195
Ayan GhoshalBiogen Inc, Cambridge, MA, United States.ORCID 0009-0008-8339-3933
Ann Marie HakeEli Lilly and Company, Cambridge, MA, United States.ORCID 0000-0001-7134-5485
Bryan J HansenJanssen Research & Development, LLC, a Johnson & Johnson company, Philadelphia, PA, United States.ORCID 0000-0003-2733-8151
Md Nurul IslamCumulus Neuroscience, Dublin, Ireland.ORCID 0000-0001-7905-7373
Judith JaegerCognitionMetrics, Wilmington, DE, United States.ORCID 0000-0002-3396-5402
Rouba KozakNeuroscience Translational Medicine, Takeda Pharmaceuticals, Cambridge, MA, United States.ORCID 0000-0002-3258-7710
Hugh MarstonCNS Diseases Research, Boehringer Ingelheim, Biberach, Germany.ORCID 0000-0002-7460-0581
Mark MossDepartment of Anatomy and Neurobiology, Chobanian & Avedisian School of Medicine, Boston University, Boston, MA, United States.ORCID 0000-0001-7330-3836
Viet NguyenBiogen Inc, Cambridge, MA, United States.ORCID 0000-0001-6867-6929
Rebecca Louise QuinnUniversity of Ulster, Coleraine, United Kingdom.ORCID 0009-0005-9006-7341
Leslie A ShinobuNeuro TRC, Bristol-Myers Squibb, Cambridge, MA, United States.ORCID 0009-0003-5886-0206
Elizabeth TunbridgeCNS Diseases Research, Boehringer Ingelheim, Biberach, Germany.ORCID 0000-0002-2966-2281
Brian MurphyCumulus Neuroscience, Dublin, Ireland.ORCID 0009-0001-7038-8210
Niamh KennedyUniversity of Ulster, Coleraine, United Kingdom.ORCID 0000-0001-7492-0828

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundClinical trials in neurological and psychiatric indications are hampered by poor measurement fidelity in currently used "standardized" rating scales. Digital, repeatable tests that can be remotely administered offer a more fine-grained understanding of the patient's clinical trajectory. Several such tools are being developed, but only a few have been validated in terms of their ability to discern and describe change over time-a critical element of clinical trials.

objectiveFour cognitive tasks from a digital battery (delivered via tablet) are administered at high frequency following an alcohol challenge to assess sensitivity to change. The tasks are novel, repeatable, and self-administered implementations of classic neurobehavioral paradigms.

methodsThirty healthy younger adults were assessed on 2 separate days, once under the influence of alcohol and once under a placebo, with order counterbalanced. Each day included 8 assessments. The tasks comprised novel, engaging implementations of the Digit Symbol Substitution Task (DSST), reaction time, N-back working memory, and visual associative/episodic memory, and were compared with benchmark measures. In-laboratory assessments were preceded by massed practice (3 sessions), and blood alcohol concentration was monitored throughout using a breathalyzer and a Visual Analog Scale.

resultsAlcohol-related impairment was observed across multiple measures, followed by a return to baseline as blood alcohol concentration declined. A slight practice effect was noted between the first and second sessions for the digital DSST, along with a longer-term effect across the 2 days. Moderate to strong correlations between digital and benchmark measures were observed at peak intoxication.

conclusionsUnder alcohol challenge, this battery, along with benchmark standardized tests, demonstrates sensitivity to subtle changes in cognitive performance over time. Practice effects are minimal within this condensed protocol. Patient-friendly, repeatable tests administered via a digital platform, such as those in the current battery, warrant further investigation in the context of remote clinical studies that require methodological approaches capable of discerning and describing small changes over time. The availability of validated single tests or test batteries as sensitive tools that can be easily and frequently administered (eg, daily) would address a critical gap: the lack of descriptors with sufficient sensitivity, specificity, and reliability to detect cognitive changes over time in clinical trials of new therapies for neurological and psychiatric conditions.

Indexed as

CognitionEthanolAdultFemaleHumansMaleNeuropsychological TestsYoung AdultEthanolalcohol challengecognitive testingdecentralized trialsmobile devicesensitivity to change

Identifiers

PMID40505117
PMCPMC12203029

What Socratic holds

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LicenceCC BY
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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 Socratic graph.