Trial reportAlzheimer's & dementia : the journal of the Alzheimer's Association2025
TRAILBLAZER-ALZ 4: A phase 3 trial comparing donanemab with aducanumab on amyloid plaque clearance in early, symptomatic Alzheimer's disease.
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 NCT05108922 (A Phase 3, Open-Label, Parallel-Group, 2-Arm Study to Investigate Amyloid Plaque Clearance With Donanemab Compared With Aducanumab-avwa in Participants With Early Symptomatic Alzheimer's Disease), which is not on this map. Cited by 21 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.
A Phase 3, Open-Label, Parallel-Group, 2-Arm Study to Investigate Amyloid Plaque Clearance With Donanemab Compared With Aducanumab-avwa in Participants With Early Symptomatic Alzheimer's Disease
Who cites it
21 citing papers in PubMed.
- TRAILBLAZER-ALZ 4: A phase 3 trial comparing donanemab with aducanumab on amyloid plaque clearance in early, symptomatic Alzheimer's disease.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025Trial
- Blood-based biomarkers and early diagnosis of Alzheimer's disease.Neural regeneration research · 2026Article
- Ocular-brain co-immunotherapy targeting amyloid-beta in Alzheimer's disease: Challenges and promising therapeutic avenues.Neural regeneration research · 2026Article
- Anti-Amyloid Antibodies in the Treatment of Alzheimer's Disease: An Umbrella Review.Journal of clinical medicine · 2026Review
- Review
- The Centiloid Scale in Amyloid PET Imaging: Current Role in Alzheimer's Disease Diagnosis, Treatment Planning, and Monitoring During Anti-Amyloid Therapy: A Clinical Perspective.Diagnostics (Basel, Switzerland) · 2026Review
- Molecular mechanisms underlying amyloid lowering by aducanumab: differential and comparative effects of sex and IgG reveal the post-treatment disease brain.bioRxiv : the preprint server for biology · 2026Article
- Alzheimer's disease: from molecular pathways to therapies.Molecular biomedicine · 2026Review
- Alzheimer's Disease: From Molecular Pathogenesis to Disease-Modifying Therapies and Clinical Implementation in Aging Populations.Clinical interventions in aging · 2026Review
- Article
- Research Progress on the Pathogenesis, Therapeutic Strategies, and Phthalocyanine Compounds for Alzheimer's Disease.Current Alzheimer research · 2026Review
- Anti-Aβ3-10 monoclonal antibody 7B8 improves cognitive function and protects the blood-brain barrier in APP/PS1 mice by regulating the HMGB-1/RAGE/NF-κB pathway.Frontiers in immunology · 2026Article
- Pharmacological Management of Mild Cognitive Impairment: From Symptomatic Treatment to Disease Modification-A Narrative Review.NeuroSci · 2025Review
- Alzheimer Syndrome or Age-Related Dementia-History, Therapy and Prevention.Journal of clinical medicine · 2025Article
- Advances of therapeutic strategies for Alzheimer's disease.Journal of neurology · 2025Review
- Ceria-nanocluster based therapy for Alzheimer's disease through the modulation of activated microglia and attenuation of amyloid-β deposition.Cell biomaterials · 2025Article
- Comprehensive medicinal chemistry survey highlights a portfolio of lead molecules for Alzheimer's disease therapy.Frontiers in chemistry · 2025Review
- Infusion-related reactions in donanemab-treated participants with early symptomatic Alzheimer's disease.Alzheimer's & dementia (New York, N. Y.)Article
- Analysis signals of disproportionate reporting associated with donanemab: A retrospective pharmacovigilance study using the FAERS database.Science progressArticle
- A prospective real-world study of the efficacy and safety of aducanumab in China: Focus on early-onset and autosomal dominant Alzheimer's disease.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
Abstract
introductionThe phase 3, open-label TRAILBLAZER-ALZ 4 study compared the effect of donanemab versus aducanumab on amyloid plaque (AP) clearance in participants with early symptomatic Alzheimer's disease.
methodsParticipants (n = 148) were randomized 1:1 to receive intravenous donanemab (700 mg every 4 weeks for three doses, then 1400 mg every 4 weeks thereafter) or aducanumab (per label). AP was measured with florbetapir F 18 positron emission tomography. AP clearance was defined as < 24.1 Centiloids.
resultsAt 6, 12, and 18 months, AP clearance was achieved in 37.9%, 70.0%, and 76.8%, respectively, of donanemab-treated participants versus 1.6%, 24.6%, and 43.1% of aducanumab-treated participants (P < 0.001). Median time to clearance was 359 versus 568 days for donanemab- versus aducanumab-treated participants (P < 0.001). Amyloid-related imaging abnormality (ARIA)-edema/effusion occurred in 23.9% and 34.8% of donanemab- and aducanumab-treated participants, respectively. DISCUSSION: Donanemab treatment resulted in earlier and greater AP clearance compared to aducanumab. ARIA frequencies were consistent with prior studies. CLINICAL
trial registrationNo: NCT05108922, TRAILBLAZER-ALZ 4 HIGHLIGHTS: Here we report the first direct comparator study of two amyloid-targeting therapies. This was the first investigation of donanemab on biomarker efficacy regardless of tau levels. Donanemab demonstrated superiority over aducanumab in amyloid plaque (AP) clearance. The depth and speed of AP removal did not affect amyloid-related imaging abnormality risk or incidence.
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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.