If you or someone you care for is considering Kisunla®, it might feel overwhelming. Terms like "anti-amyloid therapy," "ARIA," "PET scans," or "modest slowing" can be confusing regarding their impact on daily life.
This guide aims to be clear, honest, and grounded. It explains what Kisunla is, findings from significant studies, what treatment involves in real life, and how to align this therapy with personal goals. It's not meant to persuade but to inform and support shared decision-making.
What is Kisunla (donanemab)?
Kisunla® is the brand name for Donanemab, an antibody developed by Eli Lilly. It's approved for early symptomatic Alzheimer’s disease, specifically for:
People with mild cognitive impairment (MCI) due to Alzheimer’s disease, or
People with very mild Alzheimer’s dementia
Kisunla is part of a newer class of treatments called disease-modifying therapies, aiming to slow the disease process rather than just treat symptoms like memory loss or confusion.
How Kisunla works (in plain language)
Alzheimer’s disease involves abnormal proteins in the brain, such as amyloid-beta, which forms sticky plaques years before memory symptoms appear.
Kisunla is designed to:
Attach to specific amyloid plaques
Help the immune system clear amyloid from the brain
Reduce amyloid burden over time
Importantly, removing amyloid does not repair damaged brain cells. The goal is to slow further injury, allowing more time in earlier, more independent stages.
Who Kisunla is for—and who it is not
Who may be considered
Kisunla is intended for a carefully selected group of people:
With early Alzheimer’s symptoms (MCI or mild dementia)
Objective evidence of amyloid on testing (PET scan, spinal fluid, or validated blood biomarkers)
A brain MRI that meets safety criteria
Ability to attend frequent visits and monitoring
Who is usually not a candidate
Kisunla is generally not recommended for:
Moderate or advanced dementia
Cognitive changes without confirmed amyloid pathology
Significant bleeding risk in the brain
Inability to safely undergo MRI monitoring
Individuals whose goals do not align with infusion-based care
Eligibility reflects where the biology of the disease is most responsive, not a judgment about worth or effort.
The landmark study behind Kisunla
Our understanding of Kisunla comes from a significant phase 3 clinical trial called TRAILBLAZER‑ALZ 2, published in August 2023 in JAMA.
This study is considered one of the most rigorous Alzheimer’s trials to date.
Who was studied
1,736 participants, ages 60-85
All had early symptomatic Alzheimer’s disease
All had positive amyloid PET scans
Participants were grouped by tau burden (another Alzheimer’s protein that reflects disease stage)
How the study worked
Participants were randomly assigned to receive Kisunla or placebo
Treatment lasted about 72 weeks
Cognitive, functional, and biological outcomes were tracked
Brain MRIs were done regularly for safety
What the study showed—without hype
Slowing, not stopping
Across multiple measures, Kisunla:
Slowed cognitive and functional decline
Did not improve memory
Did not stop Alzheimer’s disease
Did not reverse damage
The benefit was most pronounced in people with lower or medium tau burden, indicating earlier disease biology.
What “slowing” actually means
On average, Kisunla delayed progression by:
Several months on standardized cognitive and functional scales
Roughly 4-7 months, depending on the outcome measure
For many families, this translates to:
More time managing daily tasks independently
Delayed need for increased supervision
Extended time for planning, travel, or meaningful activities
For others, the change may feel subtle.
Why biomarkers matter so much
An important lesson from Kisunla research is that biology matters more than symptoms alone.
Amyloid
Must be present for Kisunla to work
Confirmed by PET scan, spinal fluid, or blood testing
Tau
Reflects how far the disease has progressed
People with high tau burden showed less benefit
This helps explain why timing is critical
This biomarker-guided approach represents a shift toward precision medicine in Alzheimer’s care.
The “treat-to-target” model: a major difference
Unlike many long-term medications, Kisunla uses a treat-to-target strategy.
What this means
Infusions are given every four weeks
Amyloid levels are periodically reassessed
Treatment may be paused or stopped once amyloid is cleared below a threshold
Amyloid re-accumulation is typically slow
Why this matters
Some patients may not need indefinite treatment
Exposure to risk may be limited
Monitoring remains essential even after stopping
This approach is unusual in neurodegenerative disease care and has important implications for patients and caregivers.
Safety: understanding ARIA without alarm
The most significant risk associated with Kisunla is Amyloid-Related Imaging Abnormalities (ARIA).
What is ARIA?
ARIA refers to changes seen on brain MRI:
ARIA-E: swelling or fluid shifts
ARIA-H: small bleeds or blood residue
These changes are often not felt by the patient and are discovered only on scheduled MRI scans.
When symptoms occur
Possible symptoms include:
Headache
Confusion
Dizziness
Visual changes
Balance problems
New neurologic symptoms
Any new neurologic symptom during treatment requires prompt evaluation.
Who is at higher risk for ARIA
Risk is not the same for everyone.
Higher-risk groups include:
People with the APOE ε4 gene, especially those with two copies
Individuals with pre-existing brain microbleeds
People with uncontrolled blood pressure
Those receiving rapid dose escalation
Because of this, genetic testing and MRI screening are often part of the evaluation process.
How ARIA is managed
Most ARIA events:
Are mild to moderate
Resolve over weeks to months
Are managed by pausing or adjusting treatment
Severe cases are uncommon but can occur. This is why structured monitoring is not optional—it is the therapy.
Dosing evolution and improved safety
Early experience with Kisunla showed that slower dose escalation reduces ARIA risk.
As a result:
Modified titration schedules were studied
These schedules reduced ARIA-E frequency
Amyloid clearance remained effective
Regulatory labels were updated to reflect safer approaches
This evolution highlights how treatment protocols improve over time with real-world data.
What treatment looks like day-to-day
Infusion visits
Monthly IV infusions
Usually outpatient
Visits last several hours including observation
MRI monitoring
Baseline MRI before starting
Regular MRIs during early treatment
Additional MRIs if symptoms arise
Clinic follow-up
Ongoing cognitive and functional assessments
Review of goals and tolerability
Adjustments as needed
This is a care pathway, not a single intervention.
How Kisunla compares to other anti-amyloid therapies
Kisunla is one of several anti-amyloid antibodies. While details differ, they share key features:
Best suited for early disease
Modest slowing of decline
ARIA risk requiring MRI monitoring
Kisunla’s distinguishing features include:
Strong amyloid clearance
Treat-to-target stopping model
Robust tau-stratified trial data
Direct comparisons across trials should be interpreted cautiously.
Global access: why approval doesn’t always mean availability
United States
FDA approved in July 2024
Coverage expanded through Medicare registry pathways
Access depends on center capability
Europe
European authorization granted in 2025
Restricted to lower-risk genetic groups
Monitoring requirements emphasized
United Kingdom
National Institute for Health and Care Excellence (NICE) recommended against routine NHS use
Reason: high delivery and monitoring costs relative to benefit
This decision reflects system-level economics, not lack of biological effect
These differences highlight the tension between scientific progress and healthcare infrastructure.
What Kisunla does NOT do
It is just as important to be clear about limitations:
It does not cure Alzheimer’s disease
It does not restore lost memory
It does not eliminate the need for support
It does not replace lifestyle, safety, or caregiver planning
Kisunla is one tool, not a complete solution.
How to think about “modest benefit”
The word modest can feel discouraging, but context matters.
For a progressive disease:
Even small delays can mean preserved independence
Time gained may allow for life events, planning, or stability
Value varies greatly between individuals
There is no universally “right” response to these tradeoffs.
Caregiver perspective: what to expect
Caregivers often notice:
Increased appointment burden
Emotional strain during monitoring periods
Relief when stability is maintained
Uncertainty when results are subtle
Caregiver well-being matters and should be part of the decision process.
Common questions patients and families ask
"How soon will we notice a difference?"
Often, you won’t notice improvement. The goal is slower change over time.
"What if we stop?"
Stopping is reasonable if risks outweigh benefits or goals change.
"Can lifestyle still help?"
Yes. Sleep, exercise, vascular health, and engagement remain critical.
"What if we choose not to treat?"
That choice is valid. Supportive care remains essential and effective.
Shared decision-making: the most important step
Choosing Kisunla should involve:
Understanding the data
Clarifying personal goals
Weighing burden vs benefit
Revisiting the decision over time
Starting—or not starting—treatment can both be thoughtful, appropriate choices.
What this means going forward
Kisunla represents a real shift in Alzheimer’s care:
From symptom-only treatment
Toward biology-targeted intervention
With precision selection and monitoring
It also underscores a truth: progress in Alzheimer’s disease is incremental, not dramatic. Each step matters, but none stand alone.
Bottom line
Kisunla can meaningfully slow cognitive and functional decline for some people with early Alzheimer’s disease. It requires careful selection, close monitoring, and honest expectations. For many families, the value lies not in dramatic improvement, but in time—time preserved, time planned, and time lived with greater clarity.