What we are watching in Alzheimer's, as of Q2 2026

This is a living reference page. It names the threads PatientSpotlight is actively watching and how each fits into the broader picture. It does not predict timing - readouts and decisions arrive on their own schedules, and the value of the editorial coverage is in being ready to read them carefully when they do, not in betting on dates. The page is updated as the picture evolves.

For the analytical synthesis of where the field stands, see our Insight on why diagnosis is becoming staging and our Insight on international divergence defining real access. For the structured reference layer, the pipeline Snapshot, regulatory landscape Snapshot, and payer coverage Snapshot cover the current state.

Clinical readouts

GLP-1 receptor agonists in early Alzheimer's

The phase 3 readouts of GLP-1 receptor agonists in Alzheimer's - semaglutide most prominently - are anticipated within the near to mid-term. We have committed to an interpretive frame in advance: see our Insight on how to read the readout, either way. What we will be watching when the data lands: the absolute effect size on the primary endpoint, the population the effect concentrates in, the concordance across supporting endpoints, and the safety signal - particularly any neuropsychiatric or weight-related effects that did not surface in the diabetes and obesity programs.

Tau-directed programs

Multiple anti-tau programs - monoclonal antibodies, antisense oligonucleotides, small molecules - are in mid- and late-stage development. A clinically meaningful tau readout would materially expand the disease-modification toolkit and, as our Insight on the post-amyloid pipeline as a portfolio bet frames it, sharpen the case for combination over succession. What we will be watching: which programs reach pivotal readout first, whether the staging biomarker requirements (tau PET) used for trial enrolment translate to a similar requirement at label, and how the field reads small effect sizes on the cognitive endpoints in this second mechanism class.

Long-term anti-amyloid extension data

Real-world and extension-trial data on anti-amyloid antibodies - durability of clinical benefit, patient experience after the initial 18-month trial window, the question of whether finite-duration treatment paradigms hold up. The donanemab finite-duration design, where treatment is stopped after amyloid clearance, is the cleanest test case. What we will be watching: progression curves in extension and real-world cohorts, retreatment patterns, and how the durability picture interacts with payer reauthorization rules.

Regulatory and reimbursement

Subcutaneous anti-amyloid decisions

The subcutaneous formulations of the anti-amyloid antibodies are in regulatory review. Decisions, when they come, will reshape the access conversation by easing the infusion-chair side of the rollout. What we will be watching: the labelled patient population for the SC version (parity with IV or narrower), the dosing and self-administration provisions, payer coverage decisions on parity with the IV product, and whether ARIA monitoring requirements remain unchanged.

NICE and other HTA reassessments

National health-technology-assessment bodies - NICE in the UK, G-BA in Germany, CADTH in Canada, PBAC in Australia - make their decisions on their own timetables and can revisit them as new evidence arrives or prices change. Our Insight on international divergence and Signal on the NICE divergence cover the current shape. What we will be watching: pricing changes that could change cost-effectiveness conclusions, new real-world evidence submissions, and whether the divergence between approval bodies and reimbursement bodies stabilises or widens.

Accelerated-approval bar for the next mechanism

The FDA accelerated approval pathway bar in Alzheimer's is meaningfully higher than it was three years ago, as our Signal on post-aducanumab scrutiny tracks. The next test will be how the agency treats a non-anti-amyloid mechanism with biomarker-confirmed surrogate evidence. What we will be watching: the route the next sponsor of a non-amyloid mechanism chooses (accelerated vs traditional approval), the strength of the surrogate-to-clinical link in the submission, and whether confirmatory trial design is in place at the time of filing.

Medicare CED registry trajectory

CMS coverage with evidence development for anti-amyloid antibodies remains in place, with the registry obligation that comes with it. What we will be watching: whether the registry requirement is streamlined or relaxed as data accumulate, whether the emerging real-world evidence supports the original rationale for CED, and whether CMS extends or modifies the framework as the next mechanism reaches the agency.

Real-world evidence

Registry-derived ARIA and outcome data

The shift toward registry data as the binding signal - covered in our Insight on real-world data becoming the binding signal - is most visible in the ARIA conversation, where real-world rates and management patterns are now informing label-level updates and clinical-pathway design. What we will be watching: ALZ-NET and analogous registry publications on ARIA rates by APOE genotype and dose, real-world treatment-discontinuation patterns, and how registry findings translate into prescribing-information updates.

Plasma biomarker performance at scale

Plasma p-tau217 and adjacent markers continue to accumulate real-world performance data outside the original validation cohorts. What we will be watching: cross-population performance, pre-analytical handling effects in routine community practice, the maturation of staging-grade plasma tau panels (beyond the screening-grade p-tau217), and how the evolving plasma toolkit interacts with PET utilisation.

Operational rollout

Tau PET access trajectory

Tau PET is the staging tool the next era of trials and treatment selection most directly depends on. Coverage is narrower than amyloid PET, sites are fewer, and the access gap is now an active issue - see our Signal on tau PET reimbursement as the next diagnostic access question. What we will be watching: CMS and commercial coverage developments, tracer manufacturing and site expansion, and clinical-trial sponsor investment in tau-PET infrastructure.

Diagnostic capacity and the staging shift

The broader diagnostic infrastructure that supports the screening-to-staging shift is unevenly built out, as our Insight on diagnosis becoming staging describes. What we will be watching: the gap between where the diagnostic question is heading and where the available tools are, and the operational responses (training programs, telehealth-supported workflows, hub-and-spoke models) that close or fail to close it.

Patient and caregiver experience

Routine-care delivery of disease-modifying therapy is still relatively new, and the patient and caregiver experience around diagnosis, treatment initiation, monitoring, and counselling is still being characterised. Our Snapshot on the caregiver support landscape covers the support infrastructure. What we will be watching: real-world data on the diagnostic-disclosure conversation, caregiver burden under the new treatment paradigm, and the tools and resources that emerge in response.

How this page works

This page is editorial, not predictive. We do not commit to timing on any of the threads above. We do commit to covering each one as it develops - through Signals when something concrete happens, Insights when the picture firms up enough to take a position, Snapshots when the reference state changes, and Explained pieces when a new term enters the conversation. If you are tracking the field with us, this page is the index to what we are reading and writing toward.

For the most recent published pieces, the Signals collection is the place to go. For the longer-form synthesis, the Insights collection. For reference, the Snapshots collection and Explained collection.