Trial reportAlzheimer's & dementia : the journal of the Alzheimer's Association2025
Donanemab in preclinical Alzheimer's disease: Screening and baseline data from TRAILBLAZER-ALZ 3.
Trial report in Alzheimer's & dementia : the journal of the Alzheimer's Association, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05026866 (A Study of Donanemab Versus Placebo in Participants at Risk for Cognitive and Functional Decline of Alzheimer's Disease), which is not on this map. Cited by 27 papers.
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.
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.
A Study of Donanemab Versus Placebo in Participants at Risk for Cognitive and Functional Decline of Alzheimer's Disease
Who cites it
27 citing papers in PubMed.
- Digital memory assessments and plasma pTau217 enable efficient preclinical Alzheimer's trials.The journal of prevention of Alzheimer's disease · 2026Trial
- Donanemab in preclinical Alzheimer's disease: Screening and baseline data from TRAILBLAZER-ALZ 3.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025Trial
- Article
- Research satisfaction among participants in a preclinical Alzheimer's disease trial.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2026Article
- Anti-Amyloid Antibodies in the Treatment of Alzheimer's Disease: An Umbrella Review.Journal of clinical medicine · 2026Review
- More efficient screening for preclinical Alzheimer's clinical trials using mixture of experts.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2026Review
- The Promise and Peril of Alzheimer Disease Prevention.Neurology · 2026Review
- Optimized plasma p-tau217 and p-tau217/Aβ42 cutoffs enhance detection of pre-clinical Alzheimer's disease across diverse participants.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2026Observational
- Beyond the Cochrane review: Re-evaluating anti-amyloid therapy in Alzheimer's disease.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2026Article
- Multimodal biomarker characterization of amnestic objective subtle cognitive decline in aging and preclinical Alzheimer's disease.The journal of prevention of Alzheimer's disease · 2026Observational
- Recent advances in Alzheimer's disease: From molecular mechanisms to therapeutic strategies.Cell · 2026Review
- GLP-1 agonists in neurodegeneration: a multimodal biomarker-guided approach.Trends in molecular medicine · 2026Review
- Prognostic value of plasma %p-tau217 in cognitively unimpaired older adults.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2026Article
- Review
- Evaluating evidence-based recruitment strategies for Alzheimer's disease and related dementias clinical trial research: A literature review.The journal of prevention of Alzheimer's disease · 2026Review
- The best treatment is prevention: prevention of cognitive decline and dementia - current state, gaps and next steps.Neurological research and practice · 2026Article
- The emerging role of CETP inhibition in the prevention of Alzheimer's disease.American journal of preventive cardiology · 2026Review
- Remote outcome measures in Alzheimer's disease clinical trials: A call to action.The journal of prevention of Alzheimer's disease · 2026Article
- 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 · 2026Review
- The prognostic value of blood-based p-tau217 levels on progression to clinical impairment.medRxiv : the preprint server for health sciences · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
Abstract
introductionTRAILBLAZER-ALZ 3 is investigating donanemab in preclinical Alzheimer's disease (AD).
methodsThis double-blind, placebo-controlled trial used a plasma phosphorylated tau-217 (p-tau217) assay to detect AD pathology for eligibility and a decentralized design to enhance screening and enrollment. After nine monthly infusions, clinical assessments continue every 6 months with a time-to-event primary outcome. A sub-study will evaluate longitudinal changes in amyloid and tau positron emission tomography (PET).
resultsParticipants 55-80 years of age were screened (N = 63,124). Plasma p-tau217-eligible participants were enrolled (N = 2196), with Clinical Dementia Rating (CDR) scale-Global score (CDR-GS) of 0 (n = 1202) and 0.5 (n = 664). Plasma p-tau217 eligibility increased with age, differing across races and ethnicities. Mean baseline amyloid levels were 63.2 (CDR-GS: 0) and 70.7 Centiloids (CDR-GS: 0.5). Elevated global tau signal (standardized uptake value ratio ≥1.10) was observed in 15.1% and 26.3% of CDR-GS 0 and 0.5 subgroups, respectively. DISCUSSION: Utilizing a unique decentralized design, the trial showed baseline data consistent with preclinical AD.
trial registrationClinicalTrials.gov identifier: NCT05026866, TRAILBLAZER-ALZ 3 HIGHLIGHTS: TRAILBLAZER-ALZ 3 screened 63,124 participants in the United States and Japan Plasma phosphorylated tau-217 (p-tau217) was used to determine Alzheimer's disease pathology for eligibility A decentralized model was used, including remote raters for clinical testing Randomized participants had Clinical Dementia Rating scale-Global scores of 0 and 0.5.
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What Socratic holds
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 Socratic graph.