PatientSpotlight, by PanaceaIntelPatientSpotlight

Topic

Diagnosis

Coverage of how disease is diagnosed in clinical practice - biomarker testing, imaging, the categories used, and the diagnostic infrastructure that gates access to therapy. 96 pieces on this topic across therapy areas, newest first within each collection.

Signals

33
SignalNEWMay 8, 2026

AL amyloidosis therapy reshapes around daratumumab and emerging amyloid-targeted programs

Daratumumab plus bortezomib first-line, isatuximab follow-on programs, and emerging anti-amyloid antibody therapy are restructuring AL amyloidosis management.

TreatmentPipelineDiagnosisDrug development
SignalNEWMay 8, 2026

Neurotrophic keratitis acquires recombinant nerve growth factor therapy

Cenegermin (recombinant nerve growth factor) maturity, follow-on programs, and structured corneal-care pathways are reshaping neurotrophic keratitis management.

TreatmentPipelineDiagnosisPatient journey
SignalNEWMay 8, 2026

Lung cancer screening pathway integration matures

Low-dose CT screening adoption growth, AI-assisted nodule management, blood-based biomarker integration, and primary-care pathway formalisation are restructuring lung cancer screening.

DiagnosisBiomarkersPatient journeyInfrastructure
SignalNEWMay 8, 2026

Thyroid disease in pregnancy management formalises around structured monitoring

Pregnancy-specific TSH targets, structured pre-conception thyroid management, and integrated maternal-fetal medicine and endocrinology pathways are reshaping thyroid disease in pregnancy.

DiagnosisTreatmentPatient journeyInfrastructure
SignalNEWMay 8, 2026

IgG4-related disease enters real prescribing territory

Inebilizumab IgG4-RD pivotal data, rituximab maintenance protocols, and structured diagnostic pathways are reshaping IgG4-related disease management.

TreatmentPipelineDiagnosisDrug development
SignalNEWMay 8, 2026

Frontotemporal dementia therapy programs reach late-stage trials

Progranulin-replacement therapy in GRN-mutation FTD, ASO programs in C9orf72 FTD-ALS, and tau-targeted programs are emerging in a previously bare category.

TreatmentPipelineDiagnosisDrug development
SignalNEWMay 8, 2026

Dementia with Lewy bodies care formalises around alpha-synuclein-aware management

Cholinesterase inhibitor optimisation, antipsychotic-avoidance protocols, RBD recognition pathways, and emerging alpha-synuclein-targeted programs are reshaping DLB care.

DiagnosisTreatmentPatient journeyInfrastructure
SignalNEWMay 7, 2026

Proliferative diabetic retinopathy therapy reshapes around anti-VEGF

Anti-VEGF first-line for proliferative diabetic retinopathy, panretinal photocoagulation as alternative or combination, and emerging mechanism programs are reshaping PDR management.

TreatmentPatient journeyDeliveryDiagnosis
SignalNEWMay 5, 2026

Spinal muscular atrophy long-term outcome data reshapes treatment expectations

Multi-year outcome data across nusinersen, onasemnogene abeparvovec, and risdiplam plus emerging combination strategies are clarifying long-term SMA treatment expectations.

TreatmentReal world evidencePatient journeyDiagnosis
SignalNEWMay 5, 2026

Keratoconus therapy widens past corneal cross-linking

Corneal cross-linking adoption, intracorneal ring segment maturity, and emerging custom cross-linking and topography-guided treatment are reshaping keratoconus management.

TreatmentPipelineDiagnosisDelivery
SignalNEWMay 4, 2026

Refractory chronic cough acquires a first targeted mechanism class

P2X3 antagonist class entry plus follow-on novel mechanism programs are establishing chronic cough as a real prescribing category.

TreatmentPipelineDiagnosisDrug development
SignalNEWMay 4, 2026

Stroke prevention restructures across atrial fibrillation, lipids, and acute window

Factor XIa inhibitors entering late-stage trials, expanded thrombectomy windows, and tenecteplase displacement of alteplase are restructuring stroke prevention and acute care.

TreatmentPipelineDiagnosisDrug development
SignalNEWMay 4, 2026

Postmenopausal osteoporosis therapy reshapes around anabolic-first sequencing

Romosozumab maturity, ongoing teriparatide and abaloparatide use, and follow-on anabolic programs are restructuring postmenopausal osteoporosis sequencing.

TreatmentDiagnosisPatient journeyPipeline
SignalNEWMay 4, 2026

Pre-eclampsia prediction and prevention infrastructure matures

sFlt-1 to PlGF ratio testing in suspected pre-eclampsia and aspirin-prophylaxis pathway adoption are reshaping pre-eclampsia care.

DiagnosisBiomarkersPatient journeyTreatment
SignalNEWMay 4, 2026

MASH therapy class establishes after resmetirom approval

Resmetirom commercial uptake plus follow-on FGF21 analogues, GLP-1 plus glucagon, and PPAR-pan agonists are establishing a real metabolic-dysfunction-associated steatohepatitis prescribing class.

TreatmentPipelineDiagnosisDrug development
SignalNEWMay 4, 2026

Hidradenitis suppurativa biologic options widen past TNF

IL-17-class secukinumab and bimekizumab approvals plus emerging novel mechanism programs are restructuring hidradenitis suppurativa management.

TreatmentPipelineDiagnosisPatient journey
SignalNEWMay 4, 2026

Diabetic peripheral neuropathy therapy advances after a long quiet period

Capsaicin patch maturity, novel sodium channel modulators, and emerging disease-modifying programs are reshaping diabetic peripheral neuropathy management.

TreatmentPipelineDiagnosisPatient journey
SignalNEWMay 4, 2026

Sjogren disease therapy enters real prescribing territory

First positive pivotal readouts in Sjogren disease are establishing a category that has had no specific systemic therapy for decades.

TreatmentPipelineDiagnosisDrug development
SignalNEWMay 4, 2026

Inherited retinal disease gene therapy widens past RPE65

X-linked retinitis pigmentosa, choroideremia, and additional inherited retinal disease gene therapy programs are reading out.

TreatmentPipelineDiagnosisDrug development
SignalApr 30, 2026

Tardive dyskinesia therapy access patterns

Approved VMAT2 inhibitor therapy for tardive dyskinesia continues to expand but underdiagnosis remains the primary gap.

TreatmentDiagnosisAccessPatient journey
SignalApr 30, 2026

Vaping-associated lung disease as a recognised category

EVALI (e-cigarette and vaping-associated lung injury) and chronic bronchiolitis from vaping are now recognised pulmonology diagnostic categories.

DiagnosisPatient journeyPolicy
SignalApr 30, 2026

Concussion and TBI biomarker tools mature

Plasma GFAP and UCH-L1 assays for concussion and traumatic brain injury are establishing routine emergency-department use.

DiagnosisBiomarkersInfrastructure
SignalApr 30, 2026

Non-CF bronchiectasis enters the therapy frontier

Late-stage programs targeting non-CF bronchiectasis are creating the first specific therapy category for this long-overlooked condition.

PipelineTreatmentDiagnosis
SignalApr 29, 2026FDA

FDA approves leucovorin calcium as first treatment for CFD-FOLR1

The FDA has approved expanded use of Wellcovorin (leucovorin calcium) tablets for cerebral folate deficiency caused by confirmed FOLR1 gene variants, marking the first approved treatment for this rare neurological condition in adults and children.

RegulatoryGeneticsDiagnosisAccess
SignalApr 28, 2026FDA · peer-reviewed · specialty-lab

Plasma biomarker testing is displacing amyloid PET as the screening modality for anti-amyloid eligibility

Three FDA-cleared blood tests for amyloid pathology are now in routine use at major Alzheimer's centres, materially reducing the amyloid-PET demand that constrained early lecanemab uptake.

DiagnosisBiomarkersAccessScreening
SignalApr 26, 2026registry · peer-reviewed

ATTR amyloidosis silencer therapy uptake is transforming a previously underdiagnosed condition

Transthyretin amyloid cardiomyopathy (ATTR-CM) was historically underdiagnosed and undertreated. Approved silencer therapies (siRNA, ASO) and TTR stabilisers have moved the field rapidly, and the diagnostic-pathway access remains the rate-limit on commercial uptake.

TreatmentDiagnosisInfrastructure
SignalApr 26, 2026peer-reviewed · specialty-lab

Parkinson's biomarker work is converging on the alpha-synuclein seed-amplification assay

The alpha-synuclein seed-amplification assay (alpha-syn-SAA) has emerged as the leading biomarker for Parkinson's disease and adjacent synucleinopathies. The assay's sensitivity, specificity, and the implications for both diagnosis and trial-enrolment are material.

BiomarkersDiagnosis
SignalApr 26, 2026regulatory-body

UK newborn screening expansion proposal would change the rare-disease patient-finding model

The UK National Screening Committee's proposed expansion of the newborn blood-spot screening panel to additional rare conditions has implications for diagnosis timing, treatment-eligible patient identification, and commercial planning for orphan therapies in those conditions.

PolicyDiagnosis
SignalApr 26, 2026FDA · regulatory-body · peer-reviewed

Newborn screening expansion is uneven across US states

RUSP additions tell only half the story - state-level implementation timelines stretch the diagnostic-to-treatment gap, and the variation has consequences for treatment-eligibility windows in time-sensitive rare disease.

DiagnosisNewborn screeningAccessRegulatory
SignalApr 23, 2026CMS · peer-reviewed · industry-filing · health-system

Tau PET reimbursement is the next diagnostic access question

Amyloid PET has settled into routine coverage and availability. Tau PET - which will be the confirmatory pathway for tau-directed therapies - is sited at meaningfully fewer centers and reimbursed unevenly. The access conversation that defined anti-amyloid rollout is about to repeat, one mechanism later.

AccessDiagnosisBiomarkersPipeline
SignalApr 21, 2026peer-reviewed · conference · expert-interview

Co-pathology recognition is reshaping how Alzheimer's diagnosis is being read

LATE, vascular contribution, and Lewy-body co-pathology are now routinely on the differential when a patient with cognitive symptoms tests amyloid-positive. The clinical question is increasingly "what mix" rather than "is it Alzheimer's."

DiagnosisBiomarkersPipeline
SignalApr 21, 2026peer-reviewed · specialty-lab · health-system

Plasma-biomarker rollout is concentrated at academic centers

Adoption of plasma p-tau217 testing remains concentrated at academic medical centers and large specialty practices, with community uptake meaningfully behind.

DiagnosisBiomarkersAccessInfrastructure
SignalApr 15, 2026industry-filing · specialty-lab · peer-reviewed

Blood-based biomarkers move from research to clinical workflow

Plasma p-tau217 assays are being adopted as a triage step before PET or CSF confirmation in specialty memory clinics.

DiagnosisBiomarkers

Snapshots

18
SnapshotNEWMay 8, 2026

Cardiac amyloidosis therapy reference (2026)

Reference snapshot of cardiac amyloidosis therapy across AL and ATTR types.

TreatmentDiagnosisPatient journey
SnapshotNEWMay 8, 2026

Retinal vein occlusion therapy reference (2026)

Reference snapshot of RVO therapy across acute and ongoing macular edema management plus systemic care integration.

TreatmentPatient journeyDiagnosis
SnapshotNEWMay 8, 2026

Dementia subtype therapy reference (2026)

Reference snapshot of dementia therapy across Alzheimer's, dementia with Lewy bodies, vascular, and frontotemporal subtypes.

DiagnosisTreatmentBiomarkersPatient journey
SnapshotNEWMay 8, 2026

Allergic bronchopulmonary aspergillosis therapy reference (2026)

Reference snapshot of ABPA therapy across acute, recurrent, and emerging biologic-integrated tiers.

TreatmentBiomarkersDiagnosisPatient journey
SnapshotNEWMay 7, 2026

Chronic inflammatory demyelinating polyneuropathy therapy reference (2026)

Reference snapshot of CIDP therapy across induction, maintenance, and emerging biologic tiers.

TreatmentDiagnosisPatient journey
SnapshotNEWMay 7, 2026

Allergic conjunctivitis therapy reference (2026)

Reference snapshot of allergic conjunctivitis therapy across mild seasonal, persistent, severe, and emerging tiers.

TreatmentDiagnosisPatient journey
SnapshotNEWMay 7, 2026

Phenylketonuria therapy reference (2026)

Reference snapshot of PKU therapy across newborn-screened, paediatric, and adult populations.

TreatmentPatient journeyDiagnosis
SnapshotNEWMay 7, 2026

Autism spectrum disorder care reference (2026)

Reference snapshot of ASD care across behavioural therapy, educational support, pharmacotherapy for associated symptoms, and emerging core-symptom programs.

TreatmentDiagnosisPatient journeyInfrastructure
SnapshotNEWMay 5, 2026

Spinal muscular atrophy therapy reference (2026)

Reference snapshot of SMA therapy options across newborn-screened, symptomatic infant, child, and adult populations.

TreatmentPatient journeyDiagnosis
SnapshotNEWMay 5, 2026

Obstructive sleep apnea therapy reference (2026)

Reference snapshot of OSA therapy across positive airway pressure, oral appliances, surgery, neurostimulation, and emerging pharmacotherapy.

TreatmentDiagnosisDeliveryPatient journey
SnapshotNEWMay 4, 2026

Sjogren disease therapy reference (2026)

Reference snapshot of Sjogren disease therapy across symptomatic, off-label, and emerging mechanism-targeted tiers.

TreatmentDiagnosisPatient journey
SnapshotNEWMay 4, 2026

Hereditary angioedema therapy reference (2026)

Reference snapshot of HAE prophylaxis and on-demand therapy options.

TreatmentDeliveryDiagnosis
SnapshotNEWMay 4, 2026

Refractory chronic cough therapy reference (2026)

Reference snapshot of refractory chronic cough therapy across symptomatic, off-label, and emerging targeted tiers.

TreatmentDiagnosisPatient journey
SnapshotNEWMay 4, 2026

Hepatocellular carcinoma therapy reference (2026)

Reference snapshot of HCC therapy across early, intermediate, and advanced disease.

TreatmentPatient journeyDiagnosis
SnapshotNEWMay 4, 2026

Type 1 diabetes therapy reference (2026)

Reference snapshot of T1D therapy across insulin delivery, disease modification, and beta-cell replacement.

TreatmentDeliveryDiagnosis
SnapshotNEWMay 4, 2026

Postmenopausal osteoporosis therapy reference (2026)

Reference snapshot of postmenopausal osteoporosis therapy across anti-resorptive and anabolic tiers.

TreatmentPatient journeyDiagnosis
SnapshotApr 26, 2026industry-filing · FDA

ATTR cardiomyopathy treatment landscape, 2026 mid-year reference

Reference layout of the ATTR cardiomyopathy treatment landscape as of mid-2026: TTR stabilisers, TTR silencers, the diagnostic-pathway infrastructure, and the live commercial questions including diagnostic-pathway expansion and combination therapy.

TreatmentDiagnosisPipeline
SnapshotUpdated Apr 24, 2026FDA · conference · specialty-lab

Alzheimer's diagnostic pathways, as of Q2 2026

Plasma biomarkers are entering routine workflows alongside established CSF and PET options, with confirmatory imaging still standard before disease-modifying therapy.

DiagnosisBiomarkers

Explained

45
ExplainedNEWMay 8, 2026

What is AL amyloidosis?

Plain-language primer on AL amyloidosis, why early diagnosis matters so much, and how modern therapy works.

DiagnosisTreatmentPatient journey
ExplainedNEWMay 8, 2026

What is hyperemesis gravidarum?

Plain-language primer on hyperemesis gravidarum, why it is more than morning sickness, and what comprehensive care can offer.

DiagnosisTreatmentPatient journey
ExplainedNEWMay 8, 2026

What is systemic sclerosis?

Plain-language primer on systemic sclerosis (scleroderma), why it affects multiple organ systems, and what modern therapy can offer.

DiagnosisTreatmentPatient journey
ExplainedNEWMay 8, 2026

What is allergic bronchopulmonary aspergillosis?

Plain-language primer on ABPA, why it is different from typical asthma, and how modern therapy works.

DiagnosisTreatmentPatient journey
ExplainedNEWMay 8, 2026

What is achondroplasia?

Plain-language primer on achondroplasia, why it is the most common skeletal dysplasia, and what the new therapy options can offer.

DiagnosisTreatmentPatient journey
ExplainedNEWMay 8, 2026

What is thyroid cancer?

Plain-language primer on thyroid cancer, why molecular profile now matters, and how modern therapy works.

DiagnosisTreatmentPatient journey
ExplainedNEWMay 8, 2026

What is dementia with Lewy bodies?

Plain-language primer on dementia with Lewy bodies, why it is different from Alzheimer's, and how modern care works.

DiagnosisTreatmentPatient journey
ExplainedNEWMay 8, 2026

What is retinal vein occlusion?

Plain-language primer on retinal vein occlusion, why it is a vascular event, and what modern therapy can offer.

DiagnosisTreatmentPatient journey
ExplainedNEWMay 7, 2026

Autism spectrum disorder care explained

Plain-language primer on ASD care, why it is multidisciplinary, and what is changing in pharmacotherapy.

DiagnosisTreatmentPatient journey
ExplainedNEWMay 7, 2026

PCSK9 inhibitors and modern lipid therapy explained

Plain-language primer on PCSK9 and the modern range of lipid-lowering options.

TreatmentDiagnosisPatient journey
ExplainedNEWMay 7, 2026

What is ANCA-associated vasculitis?

Plain-language primer on ANCA-associated vasculitis, why it can affect multiple organs, and how modern therapy works.

DiagnosisTreatmentPatient journey
ExplainedNEWMay 7, 2026

What is cholangiocarcinoma?

Plain-language primer on cholangiocarcinoma, why molecular profiling now matters so much, and how modern therapy works.

DiagnosisTreatmentPatient journey
ExplainedNEWMay 7, 2026

What is overactive bladder?

Plain-language primer on overactive bladder, why it is common, and what the modern therapy options can offer.

DiagnosisTreatmentPatient journey
ExplainedNEWMay 7, 2026

What is chronic inflammatory demyelinating polyneuropathy?

Plain-language primer on CIDP, why immune therapy is the foundation, and what the modern options can offer.

DiagnosisTreatmentPatient journey
ExplainedNEWMay 7, 2026

What is phenylketonuria?

Plain-language primer on phenylketonuria, why early diagnosis matters so much, and what the modern therapy options can offer.

DiagnosisTreatmentPatient journey
ExplainedNEWMay 7, 2026

What is allergic conjunctivitis?

Plain-language primer on allergic conjunctivitis, the different types, and what the modern range of therapy can offer.

DiagnosisTreatmentPatient journey
ExplainedNEWMay 7, 2026

Severe COPD and biologic therapy explained

Plain-language primer on severe COPD, why biologic therapy is now an option for some patients, and what the modern combined approach can offer.

DiagnosisTreatmentPatient journey
ExplainedNEWMay 5, 2026

What is lupus nephritis?

Plain-language primer on lupus nephritis, why kidney involvement is a turning point in lupus, and how modern therapy works.

DiagnosisTreatmentPatient journey
ExplainedNEWMay 5, 2026

What are vasomotor symptoms?

Plain-language primer on hot flashes and night sweats, why they happen, and what the modern therapy options can offer.

TreatmentPatient journeyDiagnosis
ExplainedNEWMay 5, 2026

What is spinal muscular atrophy?

Plain-language primer on SMA, why genetics drives the disease, and how the modern therapy options work.

DiagnosisTreatmentPatient journey
ExplainedNEWMay 5, 2026

What is glioblastoma?

Plain-language primer on glioblastoma, why it has been so hard to treat, and what is changing in glioma therapy.

DiagnosisTreatmentPatient journey
ExplainedNEWMay 5, 2026

What is obstructive sleep apnea?

Plain-language primer on obstructive sleep apnea, why CPAP has been the standard, and what is changing in OSA therapy.

DiagnosisTreatmentPatient journey
ExplainedNEWMay 5, 2026

What is spasticity?

Plain-language primer on spasticity, why it happens after neurological injury, and what the therapy options can offer.

DiagnosisTreatmentPatient journey
ExplainedNEWMay 5, 2026

What is heart failure?

Plain-language primer on heart failure, why the modern therapy is built around four foundational classes, and what is changing.

DiagnosisTreatmentPatient journey
ExplainedNEWMay 4, 2026

Acute ischemic stroke explained

Plain-language primer on acute ischemic stroke, why time matters, and how modern therapy works.

DiagnosisTreatmentPatient journey
ExplainedNEWMay 4, 2026

What is hepatocellular carcinoma?

Plain-language primer on hepatocellular carcinoma, why it usually develops on a background of liver disease, and how the modern therapy options compare.

DiagnosisTreatmentPatient journey
ExplainedNEWMay 4, 2026

What is type 1 diabetes?

Plain-language primer on type 1 diabetes, what is changing, and how modern therapy works.

DiagnosisTreatmentPatient journey
ExplainedNEWMay 4, 2026

What is obsessive-compulsive disorder?

Plain-language primer on OCD, why it has multiple subtypes, and what therapy can offer.

DiagnosisTreatmentPatient journey
ExplainedNEWMay 4, 2026

What is thyroid eye disease?

Plain-language primer on thyroid eye disease, why it is linked to thyroid problems, and what modern therapy can offer.

DiagnosisTreatmentPatient journey
ExplainedNEWMay 4, 2026

What is Sjogren disease?

Plain-language primer on Sjogren disease, why it has been hard to treat, and what is changing.

DiagnosisTreatmentPatient journey
ExplainedNEWMay 4, 2026

What is hereditary angioedema?

Plain-language primer on hereditary angioedema, why it is different from allergy, and how modern therapy works.

DiagnosisTreatmentPatient journey
ExplainedNEWMay 4, 2026

Postmenopausal osteoporosis explained

Plain-language primer on postmenopausal osteoporosis, why bone changes after menopause, and how modern therapy works.

DiagnosisTreatmentPatient journey
ExplainedNEWMay 4, 2026

What is refractory chronic cough?

Plain-language primer on refractory chronic cough, why it is a distinct condition, and what is changing in therapy.

DiagnosisTreatmentPatient journey
ExplainedApr 28, 2026FDA · peer-reviewed

What ARIA is, and why it gates how anti-amyloid antibodies can be used

ARIA - amyloid-related imaging abnormalities - is the side effect that defines the operational and clinical experience of being on lecanemab or donanemab. Understanding what it is, who it affects more, and why it requires MRI surveillance is essential context for any conversation about anti-amyloid treatment.

SafetyTreatmentDiagnosisGenetics
ExplainedApr 26, 2026FDA · peer-reviewed

How inherited retinal dystrophy gene therapy is moving beyond RPE65

The voretigene neparvovec approval for RPE65-mediated inherited retinal dystrophy validated AAV-based gene therapy in ophthalmology. The pipeline has moved substantially beyond RPE65 to address adjacent inherited retinal dystrophy genotypes, with implications for diagnostic infrastructure, surgical delivery, and commercial planning.

PipelineTreatmentDiagnosis
ExplainedApr 26, 2026peer-reviewed

Preeclampsia screening: where biomarker-based pathways are converting

Preeclampsia screening has moved from clinical-risk-factor-driven to biomarker-augmented pathways in several markets. The methodology, the access frame, and the implications for both maternal outcomes and commercial planning around adjacent assets are worth understanding.

DiagnosisBiomarkersAccess
ExplainedApr 26, 2026peer-reviewed · specialty-lab

ctDNA-guided treatment decisions are entering routine oncology care

Circulating tumour DNA testing has moved from research-grade tool to a routine decision aid in several oncology indications. The pathways from blood draw to clinical decision are now described well enough to plan around, even though reimbursement remains uneven.

BiomarkersDiagnosisAccess
ExplainedApr 24, 2026peer-reviewed · regulatory-body · specialty-lab

What are CSF biomarkers, and how do they fit alongside plasma and PET?

CSF biomarkers - measured in cerebrospinal fluid obtained by lumbar puncture - are well-validated tests for Alzheimer's pathology that pre-date both plasma biomarkers and broad amyloid PET access. They remain in routine clinical use, particularly where PET is not available and where the diagnostic question is complex enough to warrant the procedural friction.

DiagnosisBiomarkersPatient journey
ExplainedApr 24, 2026peer-reviewed · regulatory-body · CMS

What is tau PET, and how is it different from amyloid PET?

Tau PET is a brain scan that shows the build-up of tau, the second protein associated with Alzheimer's disease. The image is closer to the clinical picture than amyloid is - tau accumulation tracks more directly with where and how a person is currently impaired. The trade-off is that tau PET is harder to access than amyloid PET, and the access gap is now a rate-limiter on multiple fronts.

DiagnosisBiomarkersPatient journeyAccess
ExplainedApr 24, 2026peer-reviewed · regulatory-body · FDA

What is mild cognitive impairment, and how is it different from "early Alzheimer's"?

Mild cognitive impairment (MCI) is a diagnostic category, not a disease. It describes cognitive decline that is more than expected for age but not severe enough to count as dementia. When that decline is caused by underlying Alzheimer's pathology, the term you will increasingly hear in clinical-trial and treatment settings is "early Alzheimer's disease" - which means MCI due to Alzheimer's plus mild dementia due to Alzheimer's, taken together.

DiagnosisPatient journeyTreatment
ExplainedApr 23, 2026peer-reviewed · regulatory-body

What is CDR-SB, and what does a small change on it actually mean?

CDR-SB is the Clinical Dementia Rating - Sum of Boxes, the cognitive and functional scale used as the primary endpoint in most late-stage Alzheimer's trials. It is a six-box, 0–18 scale, scored by a clinician from a structured interview with the patient and a caregiver.

Drug developmentTreatmentDiagnosis
ExplainedApr 23, 2026peer-reviewed · regulatory-body · expert-interview

What is co-pathology in dementia, and why does it matter?

Co-pathology means more than one disease process is contributing to someone's symptoms at the same time. In older patients with cognitive symptoms, mixed pathology is the rule, not the exception.

DiagnosisBiomarkersPatient journey
ExplainedApr 22, 2026peer-reviewed · regulatory-body · CMS

What is amyloid PET, and when is it used?

Amyloid PET is a brain scan that shows whether the amyloid protein associated with Alzheimer's disease has built up in the brain. It is used to confirm or rule out Alzheimer's pathology when the diagnosis matters.

DiagnosisBiomarkersPatient journey
ExplainedApr 22, 2026peer-reviewed · regulatory-body · specialty-lab

What are plasma biomarkers in Alzheimer's disease?

Plasma biomarkers are blood tests that look for proteins associated with Alzheimer's disease pathology. The most clinically useful one in 2026 is plasma p-tau217.

DiagnosisBiomarkersPatient journey
ExplainedMar 10, 2026peer-reviewed · FDA

Why APOE4 matters in Alzheimer's disease and treatment

APOE4 is both the strongest common genetic risk factor for late-onset Alzheimer's and a meaningful modifier of treatment safety - which is why genotyping is now part of the workup.

GeneticsSafetyTreatmentDiagnosis