Evidence map›Paper›PMID 38285515›Full record

ReviewAnnual review of medicine2024

Lessons Learned from Approval of Aducanumab for Alzheimer's Disease.

Judith L Heidebrink, Henry L Paulson

Registry-linked trialOpen access · hybridAbstract readReview
In one paragraph

Review in Annual review of medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07366346 (Telehealth-Adapted Compensatory Training and Intervention for Cognition for People With Mild Cognitive Impairment), which is not on this map. Cited by 36 papers.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed
15.0field-weighted citation impact, top 1% of its field
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.

NCT07366346 narecruitingnot on this mapstarted 2026, after this paper: background citation

Telehealth-Adapted Compensatory Training and Intervention for Cognition for People With Mild Cognitive Impairment

TypeinterventionalSponsorUniversity of FloridaRan2026 to 2027Enrolled100ConditionsMCI, Mild Cognitive Impairment, Mild Cognitive Impairment (MCI)ArmsMotivationally Enhanced Compensatory Cognitive Training for Mild Cognitive Impairment (ME-CCT-MCI), Brief Motivationally Enhanced Compensatory Cognitive Training for Mild Cognitive Impairment (bME-CCT-MCI)
3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 46 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Article
  6. Repurposed drug prioritization pipeline for a multi-arm platform trial in clinical Alzheimer's disease.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2026
    Article
  7. Vitamin DNeurochemical research · 2026
    Article
  8. Review
  9. The evolving landscape of amyloid-targeting therapies in Alzheimer's disease: progress and challenges.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2026
    Review
  10. Article
  11. Review
  12. Article
  13. Article
  14. Article
  15. Review
  16. Review
  17. Review
  18. Article
  19. Article
  20. Review
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

2 authors at 1 institution in 1 country.

Judith L HeidebrinkDepartment of Neurology, University of Michigan, Ann Arbor, Michigan, USA; email: henryp@med.umich.edu, jheide@med.umich.edu.
Henry L PaulsonDepartment of Neurology, University of Michigan, Ann Arbor, Michigan, USA; email: henryp@med.umich.edu, jheide@med.umich.edu.
University of Michigan–Ann Arbor · US

Funding

Research Education ComponentP30AG072931 · NIA · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI Henry L Paulson · 2021 to 2026
$26.5M
Mechanisms of neurodegenerative diseases: intersections with ubiquitin pathwaysR35NS122302 · NINDS · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI Henry L Paulson · 2021 to 2026
$6.4M
NIA NIH HHS P30 AG072931NINDS NIH HHS R35 NS122302
6 · The paper itself

Abstract

When the US Food and Drug Administration used the accelerated approval process to authorize the use of the antiamyloid drug aducanumab to treat Alzheimer's disease (AD), many people hoped this signaled a new era of disease-modifying treatment. But 2 years later, aducanumab's failure to launch provides a cautionary tale about the complexities of dementia and the need for a thorough and transparent review of the role that regulatory agencies and various stakeholders play in approving AD drugs. We highlight the events leading to aducanumab's controversial approval and discuss some of the key lessons learned from the drug's failure to deliver the hoped-for benefits. These lessons include the inherent limitations of antiamyloid strategies for a complex disease in which amyloid is only one of several pathological processes, the need for clinical trials that better reflect the diversity of communities affected by AD, the potential pitfalls of futility analyses in clinical trials, the need for greater transparency and other modifications to the approval process, and the dementia field's unreadiness to move from the highly controlled environment of clinical trials to the widespread and chronic use of resource-intensive, disease-modifying drugs in real-world treatment scenarios. People with dementia desperately need effective therapies. We hope that the aducanumab story will inspire changes to the approval process-changes that restore public trust and improve future efforts to deliver disease-modifying therapies to the clinic.

Indexed as

Alzheimer DiseaseAmyloid beta-PeptidesAmyloidogenic ProteinsAntibodies, Monoclonal, HumanizedHumansUnited StatesUnited States Food and Drug AdministrationaducanumabAmyloid beta-PeptidesAmyloidogenic ProteinsAntibodies, Monoclonal, Humanizedaccelerated approvalantiamyloidclinical trialsdementiadrug approvalimmunotherapy

Identifiers

PMID38285515
PMCPMC10926277
OpenAlexW4391324531

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

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.