Evidence map›Paper›PMID 41830756›Full record

Trial reportThe journal of prevention of Alzheimer's disease2026

Validation of a novel cognitive-functional outcome measure optimized for early Alzheimer's Disease: Evidence from the VIVA-MIND trial.

Jasmin A Duehring, Diane M Jacobs, David P Salmon, Andrew J MacKelfresh, Carolyn Revta, Antje Meyer, Michael Schaeffer, Sylvia Schell-Mader, Tanja Wassmann, Christine Wenzkowski and 3 more

Abstract readRandomized Controlled TrialClinical Trial, Phase IIValidation Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The journal of prevention of Alzheimer's disease, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

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

13 authors.

Jasmin A DuehringDivision of Biostatistics and Bioinformatics, University of California San Diego, La Jolla, CA, USA. Electronic address: jduehring@ucsd.edu.
Diane M JacobsDepartment of Neurosciences, University of California San Diego, La Jolla, CA, USA; Alzheimer's Disease Cooperative Study, University of California San Diego, La Jolla, CA, USA; Shiley-Marcos Alzheimer's Disease Research Center, La Jolla, CA, USA.
David P SalmonDepartment of Neurosciences, University of California San Diego, La Jolla, CA, USA; Alzheimer's Disease Cooperative Study, University of California San Diego, La Jolla, CA, USA; Shiley-Marcos Alzheimer's Disease Research Center, La Jolla, CA, USA.
Andrew J MacKelfreshDepartment of Neurosciences, University of California San Diego, La Jolla, CA, USA; Alzheimer's Disease Cooperative Study, University of California San Diego, La Jolla, CA, USA.
Carolyn RevtaDepartment of Neurosciences, University of California San Diego, La Jolla, CA, USA.
Antje MeyerVivoryon Therapeutics N.V., Halle, Germany.
Michael SchaefferVivoryon Therapeutics N.V., Halle, Germany.
Sylvia Schell-MaderVivoryon Therapeutics N.V., Halle, Germany.
Tanja WassmannVivoryon Therapeutics N.V., Halle, Germany.
Christine WenzkowskiVivoryon Therapeutics N.V., Halle, Germany.
Howard H FeldmanDepartment of Neurosciences, University of California San Diego, La Jolla, CA, USA; Alzheimer's Disease Cooperative Study, University of California San Diego, La Jolla, CA, USA.
Steven D EdlandDivision of Biostatistics and Bioinformatics, University of California San Diego, La Jolla, CA, USA; Department of Neurosciences, University of California San Diego, La Jolla, CA, USA; Alzheimer's Disease Cooperative Study, University of California San Diego, La Jolla, CA, USA; Shiley-Marcos Alzheimer's Disease Research Center, La Jolla, CA, USA.
ADCS VIVA-MIND Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCognitive-functional composite measures are increasingly used as primary efficacy endpoints in early Alzheimer's disease (AD) trials, where greater sensitivity to decline can improve trial efficiency and reduce sample size requirements.

objectivesTo compare sensitivity to decline of the Cognitive Functional Component 2 (CFC2), a novel cognitive-functional composite measure described by Raghavan et al. (2013), against the Clinical Dementia Rating - Sum of Boxes (CDR-SB) and other standard cognitive and functional outcomes including MMSE, FAQ, ADAS Cog 13 and ADCOMS using prospective randomized clinical trial data.

designThe VIVA-MIND trial was a phase 2A/2B randomized controlled trial investigating the safety and efficacy of varoglutamstat in patients with mild cognitive impairment and mild dementia due to AD.

settingThe VIVA-MIND trial was conducted between 2021-2024. It was prematurely terminated in mid-2024 by the study sponsor.

participantsThis secondary analysis uses data from 98 participants in the modified intention-to-treat population from the VIVA-MIND trial with complete neuropsychological test data. MEASUREMENTS: Standard power calculations informed by parameters estimated from linear mixed-effects models were used to determine the relative efficiency of outcome measures.

resultsThe CFC2 was more sensitive to decline than the CDR-SB in this population. Use of the CFC2 would yield a 15% reduction in required sample size relative to the CDR-SB. Application of an optimal weighting scheme further improved the sensitivity of the CFC2.

conclusionsPractically significant differences in the efficiency of clinical trials in early AD may be realized by the choice of clinical outcome measure and weighting scheme. Although further verification is needed, we replicate a previous finding that the CFC2 may outperform the CDR-SB in the early AD population.

Indexed as

Alzheimer DiseaseCognitionCognitive DysfunctionNeuropsychological TestsOutcome Assessment, Health CareAgedFemaleHumansMaleTreatment OutcomeClinical trial efficacyCognitive-functional compositesOptimal-weighting

Identifiers

PMID41830756
PMCPMC12996941

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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.