Evidence map›Paper›PMID 39144121›Full record

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

APOLLOE4 Phase 3 study of oral ALZ-801/valiltramiprosate in

Susan Abushakra, Anton P Porsteinsson, Marwan Sabbagh, David Watson, Aidan Power, Earvin Liang, Emer MacSweeney, Merce Boada, Susan Flint, Rosalind McLaine and 3 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 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing 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

21 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Review
  4. Programmed cell death: a promising management for Alzheimer's disease.Apoptosis : an international journal on programmed cell death · 2026
    Review
  5. Review
  6. Review
  7. Advances in the treatment of Alzheimer's disease.Frontiers in pharmacology · 2026
    Review
  8. Review
  9. Review
  10. Review
  11. Review
  12. Chameleonic Nature of Aβ: Implications for Alzheimer's and Other Amyloid Diseases.BioEssays : news and reviews in molecular, cellular and developmental biology · 2025
    Review
  13. Review
  14. Review
  15. Review
  16. Article
  17. Article
  18. Article
  19. Article
  20. APOLLOE4 Phase 3 study of oral ALZ-801/valiltramiprosate inAlzheimer's & dementia (New York, N. Y.)
    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

13 authors.

Susan AbushakraAlzheon, Inc. Framingham Massachusetts USA.
Anton P PorsteinssonAlzheimer's Disease Care, Research & Education Program, Department of Psychiatry University of Rochester Rochester New York USA.
Marwan SabbaghBarrow Neurological Institute and St. Joseph's Hospital Phoenix Arizona USA.
David WatsonAlzheimer's Research and Treatment Center Wellington Florida USA.
Aidan PowerAlzheon, Inc. Framingham Massachusetts USA.
Earvin LiangAlzheon, Inc. Framingham Massachusetts USA.
Emer MacSweeneyRe:Cognition Health London UK.
Merce BoadaAce Alzheimer Center Barcelona, International University of Catalunya, Barcelona, Spain and Networking Research Center on Neurodegenerative Diseases (CIBERNED), Instituto de Salud Carlos III Madrid Spain.
Susan FlintAlzheon, Inc. Framingham Massachusetts USA.
Rosalind McLaineAlzheon, Inc. Framingham Massachusetts USA.
J Patrick KesslakAlzheon, Inc. Framingham Massachusetts USA.
John A HeyAlzheon, Inc. Framingham Massachusetts USA.
Martin TolarAlzheon, Inc. Framingham Massachusetts USA.

Funding

Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study - COVID supplementR01AG065253 · NIA · ALZHEON, INC. · PI ABUSHAKRA, SUSAN · 2020 to 2024
$51.2M
NIA NIH HHS R01 AG065253
6 · The paper itself

Abstract

introductionThe approved amyloid antibodies for early Alzheimer's disease (AD) carry a boxed warning about the risk of amyloid-related imaging abnormalities (ARIAs) that are highest in apolipoprotein E (

methodsThis Phase 3 randomized, double-blind, placebo-controlled, 78-week study of ALZ-801 administered as 265 mg twice per day tablets, enrolled 50- to 80-year-old homozygotes with Mini-Mental State Examination (MMSE) ≥ 22 and Clinical Dementia Rating-Global Score 0.5 or 1.0. The study is powered to detect a 2.0 to 2.5 drug-placebo difference on the Alzheimer's Disease Assessment Scale 13-item Cognitive subscale primary outcome with 150 subjects/arm. The key secondary outcomes are Clinical Dementia Rating-Sum of Boxes and Instrumental Activities of Daily Living; volumetric magnetic resonance imaging and fluid biomarkers are additional outcomes.

resultsThe APOLLOE4 Phase 3 trial enrolled 325 subjects with a mean age of 69 years, 51% female, MMSE 25.6, and 65% mild cognitive impairment. Topline results are expected in 2024. DISCUSSION: APOLLOE4 is the first disease-modification AD trial focused on Highlights: The APOLLOE4 Phase 3, placebo-controlled, 78-week study is designed to evaluate the efficacy and safety of ALZ-801 265 mg twice per day in early Alzheimer's disease (AD) subjects with the apolipoprotein E (

Indexed as

ALZ‐801Alzheimer's diseaseamyloid betaamyloid beta oligomersanti‐aggregation agentsanti‐oligomer agentsapolipoprotein Eapolipoprotein E ε4/ε4 homozygotesdisease modificationvaliltramiprosate

Identifiers

PMID39144121
PMCPMC11322500

What OpenQuestion holds

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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.