Blood-based biomarkers move from research to clinical workflow
A blood draw is becoming the entry point to the Alzheimer's diagnostic pathway — not the endpoint.
Plasma p-tau217 assays are being adopted as a triage step before PET or CSF confirmation in specialty memory clinics.
Lecanemab uptake constrained by infusion infrastructure, not demand
The first approved disease-modifying therapy is being throttled by logistics, not biology.
Real-world rollout of lecanemab is gated by infusion-chair capacity and MRI monitoring schedules — not by patient interest or prescriber willingness.
Donanemab introduces a finite-duration treatment model
Treatment may be a course rather than a chronic commitment. The downstream economics differ accordingly.
Donanemab's protocol allows treatment cessation once amyloid plaque clearance is confirmed — a meaningfully different model from indefinite biologic dosing.
ARIA surveillance is becoming the rate-limiting step in anti-amyloid care
The MRI schedule, not the infusion schedule, is what most often delays therapy.
Amyloid-related imaging abnormalities require protocol-defined MRI at multiple intervals, and managing positive findings demands neurologist judgment that is in short supply.
APOE4 genotype is reshaping eligibility, dosing, and disclosure
A genetic test is moving from research curiosity to a near-mandatory step before disease-modifying therapy.
Anti-amyloid trial readouts and post-marketing surveillance both show APOE4 homozygotes face higher ARIA risk — pushing genotype testing into pre-treatment workflows.
GLP-1 receptor agonists enter Alzheimer's clinical trials
A drug class proven outside dementia is now being tested inside it. The result will be informative either way.
Phase 3 readouts on semaglutide in Alzheimer's are due, with mechanistic interest in metabolic, vascular, and inflammatory pathways.
Subcutaneous anti-amyloid formulations move toward filing
A weekly self-administered injection at home is fundamentally different from a biweekly infusion at a center.
Subcutaneous lecanemab data has been submitted to regulators; subcutaneous donanemab is in late development. Both reframe the access question.
Medicare's coverage-with-evidence-development decision still shapes the rollout
Reimbursement design did more to shape the anti-amyloid rollout than any clinical guideline.
The CMS coverage framework requiring registry participation has had measurable effects on which sites prescribe and where patients get treated.
FDA's accelerated approval pathway under continued post-Aduhelm scrutiny
The bar for approving a future Alzheimer's therapy on biomarker evidence alone is meaningfully higher than it was three years ago.
Aducanumab's voluntary withdrawal in 2024 left lasting institutional caution about surrogate-endpoint approvals in neurodegeneration.
Tau-targeting programs advance behind the amyloid wave
Amyloid was the first domino. Tau is the one that determines whether disease modification becomes meaningful.
Anti-tau immunotherapies and small molecules are progressing through mid-stage trials, with the field watching for the first credible clinical signal.