Evidence map›Paper›PMID 39044493›Full record

Trial reportThe journal of prevention of Alzheimer's disease2024

Change in Digital Cognitive Test Performance between Solanezumab and Placebo Groups in Preclinical Alzheimer's Disease: Secondary Analyses from the A4 Study.

K V Papp, P Maruff, D M Rentz, M C Donohue, A Liu, P S Aisen, R A Sperling

Abstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The journal of prevention of Alzheimer's disease, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Article
  6. Integrating plasma p-tau217 and digital cognitive assessments for early detection in Alzheimer's disease.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025
    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

7 authors.

K V PappKathryn V. Papp, 60 Fenwood Road; Boston, MA 02115, Telephone: 617-643-5322; Fax: 857-5461, Email Address: kpapp@bwh.harvard.edu.
P Maruff
D M Rentz
M C Donohue
A Liu
P S Aisen
R A Sperling

Funding

RECRUITMENT COREU19AG010483 · NIA · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI FELDMAN, HOWARD · 2013 to 2020
$80.6M
Research Education ComponentP30AG062421 · NIA · MASSACHUSETTS GENERAL HOSPITAL · PI Christine S Ritchie · 2019 to 2026
$36.5M
Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4) Open-Label Extension StudyR01AG063689 · NIA · BRIGHAM AND WOMEN'S HOSPITAL · PI AISEN, PAUL S., SPERLING, REISA A. · 2019 to 2024
$30.8M
NIA NIH HHS P30 AG062421NIA NIH HHS R01 AG063689NIA NIH HHS U19 AG010483
6 · The paper itself

Abstract

backgroundPrimary results from the Anti-Amyloid in Asymptomatic Alzheimer's disease Study (A4) suggested no benefit of solanezumab on its primary cognitive outcome, a composite of paper and pencil tests (the Preclinical Alzheimer's Cognitive Composite; PACC).

objectiveTo determine whether change in cognitive performance, assessed using the Computerized Cognitive Composite (C3) summary score and C3 individual tests, differed between treatment groups over 240 weeks, differed based on baseline Aβ burden, and tracked with PACC decline.

designLongitudinal analysis of cognitive change over 240 weeks on the C3 Summary Score and C3 individual tests between participants randomly assigned to solanezumab at a dose of up to 1600 mg intravenously every 4 weeks versus placebo.

settingThe A4 study took place at 67 sites in Australia, Canada, Japan and the United States.

participantsCognitively unimpaired older adults (n=1117, Mean Age=71.9, 60.7% female) with elevated brain amyloid levels on 18F-florbetapir positron-emission tomography (PET) at baseline (n=549 in the solanezumab group; n=568 in the placebo group). MEASUREMENTS: Participants completed the C3 battery and PACC every 6 months. The C3 Summary Score combines the Cogstate Brief Battery (CBB)-One Card Learning, the Behavioral Pattern Separation (BPS) Test- Object- Lure Discrimination Index, and the Face Name Associative Memory Exam (FNAME)- Face-Name Matching.

resultsChange on the C3 Summary Score was moderately correlated with change on the PACC (Spearman's corr=0.53, 95% CI: 0.49 to 0.57; p<0.001). At 240 weeks, mean change in the C3 Summary Score did not differ between groups; +0.24 in the solanezumab group and +0.27 in the placebo group (mean difference= -0.02; 95% CI: -0.13 to 0.08; p = 0.650). Lack of a treatment effect was similarly observed across most individual C3 tests. Performance on the C3 tests were influenced by level of amyloid burden, where higher levels were associated with worse performance.

conclusionThis study provides corroborating evidence that solanezumab does not slow cognitive decline in preclinical AD as exhibited with a computerized cognitive assessment with some evidence that solanezumab may exacerbate cognition on select digital outcomes. This study also provides important information that amyloid related cognitive change manifests differently on individual C3 tests.

Indexed as

Alzheimer DiseaseAntibodies, Monoclonal, HumanizedNeuropsychological TestsAgedAmyloid beta-PeptidesAniline CompoundsCognitionDouble-Blind MethodFemaleHumansLongitudinal StudiesMalePositron-Emission TomographyAmyloid beta-PeptidesAniline CompoundsAntibodies, Monoclonal, Humanizedsolanezumabclinical trialcomputerized cognitive assessment.digital cognitive assessmentpreclinical Alzheimer’s diseaseSolanezumab

Identifiers

PMID39044493
PMCPMC11266374

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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.