Trial reportThe journal of prevention of Alzheimer's disease2025
The effect of modified donanemab titration on amyloid-related imaging abnormalities with edema/effusions and amyloid reduction: 18-month results from TRAILBLAZER-ALZ 6.
Trial report in The journal of prevention of Alzheimer's disease, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05738486 (Investigating the Effect of Different Donanemab Dosing Regimens on ARIA-E and Amyloid Lowering in Adults With Early Symptomatic Alzheimer's Disease), which is not on this map. Cited by 13 papers.
What it found
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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.
Investigating the Effect of Different Donanemab Dosing Regimens on ARIA-E and Amyloid Lowering in Adults With Early Symptomatic Alzheimer's Disease
Who cites it
13 citing papers in PubMed.
- Clinical Meaningfulness of Donanemab in Early Symptomatic Alzheimer Disease: Data From the Randomized Phase 3 TRAILBLAZER-ALZ 2 Trial.Neurology. Clinical practice · 2026Trial
- Donanemab in early symptomatic Alzheimer's disease: results from the TRAILBLAZER-ALZ 2 long-term extension.The journal of prevention of Alzheimer's disease · 2026Trial
- [Anti-amyloid antibodies against Alzheimer's disease : Lecanemab and donanemab in practice-Clinical importance, patient selection and safety management].Der Nervenarzt · 2026Article
- Anti-Amyloid Monoclonal Antibodies in Early Alzheimer Disease: Lecanemab and Donanemab.Neurology international · 2026Review
- Further data to address the Alzheimer's coverage with evidence development questions.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2026Review
- Amyloid-Related Imaging Abnormalities in Anti-amyloid Therapy: Clinical Implications of Kinetics for Safer Use and Risk Stratification.Clinical drug investigation · 2026Review
- [Progress and controversies surrounding disease-modifying treatments for Alzheimer's disease].Atencion primaria · 2026Article
- A Narrative Review of Amyloid-β Monoclonal Antibodies for Alzheimer Disease: How Amyloid Species Engagement May Affect Clinical Outcomes.The neurologist · 2026Review
- Anti-amyloid therapies and the transformation of Alzheimer's care pathways: early lessons from the frontline.The Lancet regional health. Europe · 2026Review
- Disease modifying treatments for Alzheimer's disease: Clinician perspectives.Journal of Alzheimer's disease : JAD · 2026Article
- Real-world implementation of lecanemab and donanemab in an Italian memory center: a 1-year experience.Alzheimer's research & therapy · 2026Observational
- Evolving Alzheimer's Disease Clinical Practice: Updated Diagnostic Criteria, Fluid Biomarkers, and Special Considerations for Anti-Amyloid Therapies.Psychiatry investigation · 2026Article
- Experience with donanemab over a 1-year period: observations of side effects and compliance from a regional specialty medical center.Alzheimer's & dementia (Amsterdam, Netherlands)Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The TRAILBLAZER-ALZ 6 study (NCT05738486) evaluated the effect of different donanemab dosing regimens on amyloid-related imaging abnormalities with edema/sulcal effusions (ARIA-E). The modified titration arm met the primary outcome and significantly reduced ARIA-E frequency compared with the standard dosing while maintaining a similar pharmacodynamic effect on amyloid reduction at 24 weeks. Primary outcome and 52-week data were previously published. Completed study results at 76 weeks are reported here. ARIA-E frequencies were 15.6 % and 24.2 % in the modified titration and standard arms, respectively. ARIA-E radiographic severity was significantly lower (p = 0.015) with modified titration than with standard dosing. Additionally, symptomatic ARIA-E frequency was lower with modified titration versus standard dosing (2.8 % vs 4.8 %). The frequency of serious adverse events was comparable between the modified titration and standard dosing arms. A more gradual titration of donanemab dosing significantly reduced ARIA-E risk versus standard dosing. CLINICALTRIALS.GOV: NCT05738486.
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