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 therapyIf 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 PETNow many programs use:
Symptoms
→ blood biomarker panel
(Aβ42/40 + p-tau)
→ PET confirmation only if positiveThis 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 appearLeqembi 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 measuresWhy 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 CSFThis 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