Evidence map›Paper›PMID 39044492›Full record

Trial reportThe journal of prevention of Alzheimer's disease2024

Longitudinal Trajectories of the Cognitive Function Index in the A4 Study.

R E Amariglio, J D Grill, D M Rentz, G A Marshall, M C Donohue, A Liu, P S Aisen, R A Sperling

Abstract readRandomized Controlled TrialMulticenter Study
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 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing 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

13 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. Study partner characteristics moderate the prediction of cognitive decline in aging.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025
    Article
  11. Article
  12. Article
  13. 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

8 authors.

R E AmariglioRebecca E. Amariglio, Department of Neurology, Mass General Brigham, 60 Fenwood Road, Boston, MA 02115, USA, Email: ramariglio@mgh.harvard.edu, Telephone: 617-732-9014, FAX: 617-738-9122.
J D Grill
D M Rentz
G A Marshall
M C Donohue
A Liu
P S Aisen
R A Sperling

Funding

The Alzheimer's Clinical Trial Consortium - Down Syndrome Network (ACTC- DSN)U24AG057437 · NIA · UNIVERSITY OF SOUTHERN CALIFORNIA · PI Paul S. Aisen, RONALD C PETERSEN · 2018 to 2026
$198.4M
RECRUITMENT COREU19AG010483 · NIA · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI FELDMAN, HOWARD · 2013 to 2020
$80.6M
Research Education ComponentP30AG062421 · NIA · MASSACHUSETTS GENERAL HOSPITAL · PI STEVEN E ARNOLD · 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 AG010483NIA NIH HHS U24 AG057437
6 · The paper itself

Abstract

backgroundThe Anti-Amyloid in Asymptomatic Alzheimer's Disease (A4) Study failed to show a treatment benefit with solanezumab, but the longitudinal consequences of elevated amyloid were observed in study participants with objective decline on the Preclinical Alzheimer Cognitive Composite (PACC) and subjective decline on the combined Cognitive Function Index (participant + study partner CFI), during the trial period.

objectivesWe sought to expand on previous findings by comparing longitudinal patterns of participant and study partner CFI separately and their associations with the PACC stratified by baseline amyloid tertile over the course of the A4 Study.

designCognitively unimpaired older adult participants and their study partners were independently administered the CFI at screen prior to amyloid PET disclosure and then at 3 subsequent visits (week 48, week 168, week 240) of the study. PACC collected at visits concurrent with CFI administration were also examined longitudinally.

settingThe A4 Study was conducted at 67 sites in Australia, Canada, Japan, and the United States.

participants1,147 participants with elevated amyloid based on florbetapir PET were enrolled in the A4 Study and included in these analyses. 583 were on placebo and 564 were treated with solanezumab. MEASUREMENTS: The PACC was used to assess objective cognitive performance and the CFI was used to assess change in everyday cognitive functioning by the participant and their study partner independently. Amyloid level was characterized by Centiloid tertiles (<46.1 CL, 46.1 to 77.2 CL, >77.2 CL). Participants were aware of their elevated amyloid status, but not their CL tertile, or specific level of amyloid. Longitudinal correlations between participant and study partner CFI and PACC were examined at all visits where assessments were available. The impact of baseline amyloid tertile on CFI and PACC associations was also examined.

resultsBoth participant and study partner CFI increased over the duration of the study indicating worsening cognitive functioning. Results did not differ by treatment group. The association between higher CFI and worse PACC for both for participant and study partner became progressively stronger over the course of the study. PACC had a significantly higher correlation with study partner CFI than with participant CFI by week 168. The stronger correlations between study partner CFI and PACC were driven by those in the highest amyloid tertile.

conclusionBoth participant and study partner report captured subtle changes in everyday cognitive functioning for participants with biomarker confirmed and disclosed preclinical AD. Moreover, study partner report was most highly aligned with cognitive decline, particularly among those with the highest amyloid load.

Indexed as

Alzheimer DiseaseAntibodies, Monoclonal, HumanizedPositron-Emission TomographyAgedAged, 80 and overAmyloid beta-PeptidesAniline CompoundsCognitionCognitive DysfunctionEthylene GlycolsFemaleHumansLongitudinal StudiesMaleNeuropsychological TestsAmyloid beta-PeptidesAniline CompoundsAntibodies, Monoclonal, HumanizedEthylene GlycolsflorbetapirsolanezumabAmyloidpositron emission tomographypreclinical Alzheimer’s diseasesubjective cognitive decline

Identifiers

PMID39044492
PMCPMC11266220

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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.