Five breakthrough moments from AAIC 2025 that are reshaping Alzheimer's research
Nearly 19,000 researchers, clinicians, and industry leaders descended on Toronto this summer for AAIC 2025, and the energy was unmistakable. The conference served as a platform for presenting new findings across the spectrum of Alzheimer’s disease (AD) research. Here are five developments from the conference that caught Dr Laurentiu Gutiu’s attention and could reshape how you approach your next neuroscience trial.
Trontinemab delivers on precision targeting in early symptomatic AD1
The results for Trontinemab’s Phase Ib/IIa trial were really exciting – the bispecific monoclonal antibody uses their BrainshuttleTM technology to enhance delivery across the blood–brain barrier. The results showed 91% of participants became amyloid PET negative after just 28 weeks - with deep plaque clearance in 72% of cases and ARIA-E rates under 5%, including in APOE4 homozygotes.
This isn't just another incremental improvement. It's evidence that precision drug delivery can transform efficacy while maintaining safety, even in high-risk APOE4 homozygotes. The Phase III trials launching next year will be worth watching closely.
Real-world data validates the anti-amyloid approach2
One of the most compelling story at AAIC wasn't from a single trial—it came from observational studies tracking thousands of patients receiving Leqembi® and Kisunla™ across diverse clinical settings. The headline? ARIA rates were actually lower than clinical trial data suggested, and patients showed stabilization or modest cognitive improvements.
This matters because it bridges the gap between controlled trial environments and clinical reality – with data supporting the effectiveness and safety of these therapies in routine clinical practice.
Blood based biomarkers get their clinical moment3
AAIC 2025 delivered the first clinical practice guidelines for blood-based biomarkers (BBM) in Alzheimer's diagnosis. The criteria are straightforward: biomarkers with ≥90% sensitivity and specificity can be used for confirmation use, while those with ≥90% sensitivity and ≥75% specificity work for triage.
This shift could fundamentally change how you design inclusion criteria and reduce screen failure rates. Instead of expensive PET scans or lumbar punctures, blood tests could streamline patient identification and enrollment. This could improve diagnostic access and scalability, particularly in primary care settings.
Lifestyle interventions prove their worth at scale4
The U.S. POINTER trial results reminded everyone that not every breakthrough comes from a laboratory. With over 2,000 participants between 60-79 years old and at risk for cognitive decline, this lifestyle intervention study showed that structured programs combining exercise, MIND diet, cognitive training, and health monitoring delivered statistically significant gains in global cognition over self-guided approaches.
What's remarkable is the consistency across demographic and genetic subgroups. For combination trials or prevention studies, this data provides a robust foundation for multi-modal approaches.
Vascular targets enter the conversation5
NewAmsterdam Pharma's BROADWAY, Phase 3, 52-week sub-study signals the support for further exploration of vascular-targeted therapies for AD prevention. Their CETP inhibitor Obicetrapib reduced plasma biomarkers associated with Alzheimer's Disease pathology e.g., pTau181, NfL) in around 2000 cardiovascular disease patients, suggesting vascular-targeted therapies deserve serious consideration for prevention trials.
What this means for your next trial
The landscape is shifting faster than many expected. For clinical research directors, this creates both opportunity and complexity. Success increasingly depends on precise patient selection, optimized delivery mechanisms, and smart trial designs that reflect clinical reality.
The momentum from AAIC 2025 isn't just about individual breakthroughs—it's about a maturing field where multiple approaches are finally delivering results. That's the kind of environment where thoughtful trial design and execution make the difference between programs that advance and those that get left behind.
Ready to turn these insights into your next successful neuroscience trial? Let's talk about how Fortrea can help you navigate this evolving landscape.
- 1. Hardy, J., et al. (2025). Trontinemab Phase Ib/IIa results: Enhanced amyloid clearance via Brainshuttle™. Roche, AAIC 2025.
- 2. Cummings, J., et al. (2025). Real-world effectiveness and safety of lecanemab and donanemab. AAIC 2025.
- 3. Alzheimer’s Association. (2025). Clinical practice guidelines for blood-based biomarkers in Alzheimer’s diagnosis. AAIC 2025.
- 4. Rabin, J. S., et al. (2025). U.S. POINTER: Cognitive outcomes of a lifestyle intervention in older adults at risk for dementia. Presented at AAIC 2025, Toronto.
- 5. NewAmsterdam Pharma. (2025). Obicetrapib reduces Alzheimer’s biomarkers in BROADWAY sub-study. AAIC 2025.