Eligibility & Workup
Indication, inclusion/exclusion, biomarkers, imaging, cognitive staging

A. Basic indication

  • early Alzheimer’s disease

  • MCI due to AD

  • mild AD dementia

  • confirmed amyloid pathology

B. Core eligibility questions

  • What cognitive stage qualifies?

  • What biomarker evidence is needed?

  • What baseline MRI findings matter?

  • Who is excluded or higher risk?

C. Real-world workup

  • clinical interview

  • functional history

  • cognitive testing

  • biomarker confirmation

  • MRI review

  • medication review

  • discussion of APOE testing

D. Neuropsychology questions

  • What testing is required versus helpful?

  • Which tools are sensitive enough for early disease?

  • How is decline or stability followed over time?

  • What role does formal neuropsych play versus screening batteries?

The clinical framing here is supported by the prescribing information and appropriate use recommendations: treatment is for early AD with confirmed amyloid, and patient selection should include a structured assessment of stage, imaging, and risk-benefit profile.

The Simplified Biological Timeline of Alzheimer’s

Think of Alzheimer’s disease as unfolding in three major biological phases.

1. Amyloid deposition (earliest phase)

This begins 10–20 years before symptoms.

What happens biologically
• Amyloid beta accumulates in plaques in the brain
• Soluble Aβ42 in blood and CSF decreases because it is being trapped in plaques

Biomarkers that detect this stage:

MarkerWhat it measuresAβ42/40 ratioEarly amyloid pathologyAmyloid PETDirect plaque imagingPET centiloidsStandardized plaque burden scale

Interpretation example from your table:

  • Aβ42/40 ≤ ~0.15 → higher likelihood of amyloid plaques

  • PET centiloid >20 → amyloid positive

  • ~50+ CL → clearly abnormal plaque burden

This is the first gate for Leqembi eligibility.

2. Tau pathology (middle phase)

After amyloid accumulates, abnormal tau begins to spread.

What happens biologically
• Tau becomes phosphorylated
• Neurofibrillary tangles develop
• Tau pathology spreads through brain networks

Biomarkers detecting this stage:

MarkerMeaningp-tau217Highly specific AD tau pathologyp-tau181Earlier tau biomarkerTau PETImaging of tau deposition

Your table thresholds reflect this stage:

  • p-tau217 > 0.15 pg/mL → abnormal

  • p-tau181 > ~1.07 pg/mL → abnormal

These markers strongly predict amyloid PET positivity and future cognitive decline.

Many programs now use blood p-tau tests to triage who should get PET scans.

3. Neurodegeneration (later phase)

This is when brain injury and cognitive decline become measurable.

What happens biologically
• synaptic loss
• neuronal death
• brain atrophy

Markers here include:

MarkerWhat it showsMRIhippocampal atrophyFDG PETreduced brain metabolismNeuropsych testingcognitive impairment

This is where patients start showing symptoms.

How This Relates to Leqembi Eligibility

Leqembi works by removing amyloid plaques, so treatment must begin before extensive neurodegeneration occurs.

Programs therefore look for patients in the “early symptomatic” window:

Amyloid present
+
Early symptoms
(MCI or mild dementia)
+
Acceptable MRI safety

Eligible for anti-amyloid therapy

If treatment occurs too late, removing amyloid may not reverse the downstream damage.

Where Each Marker in Your Table Fits

MarkerPhase of diseaseRole in screeningAβ42/40 ratioEarly amyloidblood screeningAmyloid PET centiloidsAmyloid plaque burdenconfirm pathologyp-tau217Tau pathologystrong AD predictorp-tau181Tau pathologyearlier tau biomarkerAPOE genotypeRisk modifierARIA safety risk

So your table essentially combines three types of information:

1️⃣ Amyloid detection
2️⃣ Tau pathology detection
3️⃣ Treatment safety risk

Why Blood Biomarkers Are Becoming Important

Historically the pathway was:

Symptoms
→ cognitive testing
→ amyloid PET

Now many programs use:

Symptoms
→ blood biomarker panel
(Aβ42/40 + p-tau)
→ PET confirmation only if positive

This reduces cost and speeds triage.

A Useful Mental Model

You can think of the Alzheimer biomarker sequence like this:

Amyloid starts accumulating

Tau pathology develops

Neurodegeneration begins

Cognitive symptoms appear

Leqembi is targeting the first step in that chain.

If you're building your Squarespace learning page

One helpful section could be titled:

Biological Markers of Alzheimer’s Disease

Subsections:

• Amyloid biomarkers
• Tau biomarkers
• Neurodegeneration markers
• Genetic risk modifiers

This structure mirrors the ATN research framework used in Alzheimer’s science.

If you'd like, I can also show you something that will be extremely useful for someone in your role:

A very clear table of what most real-world Leqembi programs require for eligibility, including typical cognitive scores, MRI findings, and exclusion criteria. It’s one of the things that tends to be surprisingly variable across programs.

Biomarkers used in Alzheimer’s diagnosis and treatment eligibility

Subsections:

Tau biomarkers

  • p-tau217

  • p-tau181

Amyloid biomarkers

  • Aβ42/40 ratio

  • amyloid PET centiloids

Genetic risk modifiers

  • APOE genotype

For each include:

  • what it measures

  • why it matters

  • typical thresholds

  • role in treatment workflow

Tau biomarkers

  • What it reflects

    Phosphorylated tau-217 reflects tau pathology driven by amyloid deposition.

    High levels are strongly associated with:

    • amyloid plaques

    • Alzheimer’s disease pathology

    • progression from MCI to AD

    Many studies show p-tau217 correlates extremely well with amyloid PET positivity.

    In a clinical workflow

    Programs may use it to:

    Patient with cognitive complaints

    Blood biomarker panel

    p-tau217 elevated?

    High likelihood of AD pathology

    Proceed to amyloid confirmation (PET or CSF)

    RESEARCH

    • Janelidze et al., Nature Medicine 2020

    • Palmqvist et al., JAMA 2020

    • Karikari et al., Lancet Neurology 2020

    Key search phrase: plasma p-tau217 amyloid PET correlation

    These papers show diagnostic accuracy often >90% for amyloid positivity.


    What it measures

    Why it matters

    Typical thresholds

    Role in treatment workflow

  • This is an earlier blood biomarker but still widely used.

    What it reflects

    Similar to p-tau217 but slightly less specific.

    Elevated p-tau181 is associated with:

    • amyloid pathology

    • tau accumulation

    • progression to Alzheimer’s disease

    Clinical role

    Some programs use either p-tau217 or p-tau181 depending on lab availability.

    Generally:

    ptau217 > ptau181 in diagnostic accuracy

    But p-tau181 is still extremely useful.

    Research starting points

    Search:

    plasma ptau181 Alzheimer diagnostic accuracy

    Key paper:

    • Thijssen et al., Nature Medicine 2020

    What it measures
    Why it matters
    Typical thresholds
    Role in treatment workflow

Amyloid biomarkers

  • This is a genetic risk modifier, not a diagnostic biomarker.

    Why programs care about it

    APOE ε4 carriers have higher risk of ARIA (amyloid-related imaging abnormalities), the main safety issue with Leqembi.

    ARIA risk increases roughly:

    Genotype & ARIA risk

    • E2/E3lower

    • E3/E3moderate

    • E3/E4higher

    • E4/E4highest

    Many programs offer APOE testing before treatment so patients understand the risk.

    However: APOE genotype does NOT determine eligibility, only risk counseling.

  • This is one of the most important blood screening markers.

    What it reflects

    Amyloid beta 42 decreases in the bloodstream when it is being deposited in plaques in the brain.

    So the ratio of Aβ42 to Aβ40 decreases when amyloid plaques are present.

    Lower ratio = more likely amyloid pathology.

    Typical interpretation/lab ranges:

    Ratio Interpretation

    • ≥0.17 likely negative

    • 0.15-0.169 intermediate

    • ≤0.15 likely amyloid positive

    Clinical workflow

    Blood testing can screen patients:

    Cognitive complaint

    Blood biomarker panel

    Low Abeta 42/40 ratio

    High likelihood of amyloid pathology

    Confirm with PET or CSF

    This approach helps reduce unnecessary PET scans.

    What it measures
    Why it matters
    Typical thresholds
    Role in treatment workflow

  • Centiloid is a standardized scale for amyloid PET results.

    It converts PET tracer signal into a common numeric scale so results can be compared across studies.

    Approximate interpretation

    Centiloids Meaning

    <10 amyloid negative

    10-20 borderline

    20 amyloid positive

    ~50+ moderate-high plaque burden

    Clinical trials for anti-amyloid therapies generally require clear amyloid positivity.

    What it measures
    Why it matters
    Typical thresholds
    Role in treatment workflow

Genetic risk modifiers

  • What it measures

    Why it matters

    Typical thresholds

    Role in treatment workflow

  • What it measures

    Why it matters

    Typical thresholds

    Role in treatment workflow