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- The quick answer: what are the two FDA-approved medications?
- “Slow” is not “stop”: what the evidence actually shows
- Medication #1: Leqembi (lecanemab)
- Medication #2: Kisunla (donanemab)
- Leqembi vs. Kisunla: a plain-English comparison
- What makes someone a good candidate?
- Costs, coverage, and the “healthcare logistics” reality
- What to ask a neurologist or memory clinic
- Important safety note (non-negotiable)
- : Real-world experiences families commonly report
- Conclusion
For decades, Alzheimer’s treatment felt like bringing a squirt gun to a five-alarm fire: helpful for symptoms,
but not exactly changing the trajectory. Now, the conversation has shifted. In the United States, two
FDA-approved anti-amyloid medicinesgiven in carefully monitored medical settingshave been shown to
modestly slow cognitive and functional decline for some people in the early stages of Alzheimer’s disease.
That’s not a cure. It’s not a “memory reset.” But it is a meaningful new option for certain patients who meet
specific medical criteria.
This article breaks down what these two medications are, who they’re for, what “slowing” really means,
the safety and monitoring realities (yes, MRIs are part of the deal), and what patients and families commonly
experience in real life while navigating treatment.
The quick answer: what are the two FDA-approved medications?
As of now, the two FDA-approved disease-modifying therapies that are commonly described as “slowing Alzheimer’s”
are:
- Leqembi (generic name: lecanemab)
- Kisunla (generic name: donanemab)
Both target amyloid-beta, a protein that can build up into plaques in the brainone of the hallmark features
of Alzheimer’s. Both are intended to be started in people with mild cognitive impairment (MCI) due to Alzheimer’s
or mild Alzheimer’s dementia (often called “early Alzheimer’s”), and both require confirmed amyloid pathology
(usually via amyloid PET imaging or cerebrospinal fluid testing).
“Slow” is not “stop”: what the evidence actually shows
When people hear “slows Alzheimer’s,” it’s easy to imagine a dramatic before-and-after. In clinical trials, the benefits
are better understood as less decline over time compared with placebomeasured using standard scales that track memory,
thinking, and daily function. Think of it like reducing the steepness of a downhill slope. You’re still going downhill, but
(for some patients) at a slower pace.
Why early stage matters
These medicines were studied in early symptomatic Alzheimer’swhen there’s enough brain function left to preserve and
enough disease activity to target. Starting too late (moderate to severe dementia) hasn’t been shown to provide the same
benefit, and could add risk without clear payoff.
Why amyloid confirmation matters
Alzheimer’s-like symptoms can come from many causes (vascular changes, medication side effects, depression, thyroid issues,
sleep apnea, and more). These drugs are designed for Alzheimer’s disease with evidence of amyloidso clinicians typically confirm
amyloid before treatment, rather than guessing based on memory tests alone.
Medication #1: Leqembi (lecanemab)
Leqembi (lecanemab) is an anti-amyloid monoclonal antibody. It received FDA accelerated approval in early 2023 and was
later converted to traditional approval after confirmatory trial evidence supported clinical benefit.
Who it’s for
Leqembi is intended for adults with Alzheimer’s disease in the MCI or mild dementia stagespecifically the population
studied in clinical trials. It’s not meant as a general “memory booster” and it is not approved for prevention in people with no symptoms.
How it’s given
Leqembi treatment typically begins as an intravenous (IV) infusion given on a schedule laid out in prescribing information.
After an initial course, maintenance dosing options may include a less frequent IV schedule andmore recentlyan FDA-approved
subcutaneous autoinjector for maintenance dosing in appropriate patients, which can reduce the burden of frequent infusion-center visits.
What “benefit” looked like in trials
In a large randomized trial of people with early Alzheimer’s disease, lecanemab was associated with a statistically significant
reduction in decline compared with placebo over 18 months. Researchers also observed reductions in amyloid markers, consistent with
the drug’s mechanism.
The big safety issue: ARIA (and why MRIs come with the territory)
Leqembi carries a boxed warning for amyloid-related imaging abnormalities (ARIA), which can include brain swelling (ARIA-E)
and small brain bleeds or related findings (ARIA-H). Many ARIA cases cause no symptoms and are found only on MRIbut serious events can occur.
That’s why clinicians use baseline and follow-up brain imaging as part of treatment safety.
Risk isn’t evenly distributed. People who carry certain APOE ε4 genotypesespecially those with two copieshave higher ARIA risk,
and the FDA has emphasized genetic testing as part of risk discussion and decision-making with patients.
Practical takeaway for families
- Expect baseline testing (to confirm amyloid and assess MRI suitability).
- Expect scheduled MRIs early in treatmentand sometimes extra MRIs if symptoms show up.
- Expect shared decision-making: benefits, risks, your health history, and your goals all matter.
Medication #2: Kisunla (donanemab)
Kisunla (donanemab) is another anti-amyloid monoclonal antibody approved by the FDA for Alzheimer’s disease in adults. Like lecanemab,
it is intended for treatment initiation in early symptomatic stages (MCI or mild dementia), and it is administered under medical supervision.
Who it’s for
The FDA approval specifies use in patients with mild cognitive impairment or mild dementia stage of Alzheimer’s diseasethe same general
early-stage window where these anti-amyloid therapies have been studied.
How it’s given (and a unique feature: potentially stopping when amyloid is reduced)
Kisunla is administered as an IV infusion every four weeks. A distinctive aspect of Kisunla’s prescribing approach is that clinicians may
consider stopping dosing once amyloid plaques have been reduced to minimal levels based on amyloid PET imaging, reflecting how dosing
was handled in key studies.
What “benefit” looked like in studies
In clinical studies of early symptomatic Alzheimer’s disease, donanemab was associated with slower cognitive and functional decline compared with placebo.
As with lecanemab, the effect is best described as a modest slowingpotentially meaningful at the individual level, but not a reversal of disease.
Safety and monitoring: ARIA is also a central concern
Kisunla also carries a boxed warning for ARIA. Because ARIA can be asymptomatic yet clinically important, treatment programs commonly include a baseline MRI
and follow-up MRIs at specified times, plus additional imaging if symptoms suggest ARIA.
Notably, the FDA has also approved labeling updates that adjust dosing to help reduce ARIA risk, reflecting ongoing efforts to make therapy safer and easier
to manage in real-world practice.
Leqembi vs. Kisunla: a plain-English comparison
| Feature | Leqembi (lecanemab) | Kisunla (donanemab) |
|---|---|---|
| What it targets | Amyloid-beta (anti-amyloid antibody) | Amyloid-beta (anti-amyloid antibody) |
| Who it’s for | Early Alzheimer’s (MCI or mild dementia) with confirmed amyloid | Early Alzheimer’s (MCI or mild dementia) with confirmed amyloid |
| How it’s given | IV infusion initially; maintenance options may include less frequent IV and/or subcutaneous autoinjector | Monthly IV infusion |
| Monitoring | Baseline + scheduled MRIs; extra MRI if symptoms occur | Baseline + scheduled MRIs; extra MRI if symptoms occur |
| Key safety concern | ARIA (brain swelling/bleeding findings) | ARIA (brain swelling/bleeding findings) |
| Can treatment stop? | Ongoing therapy with defined maintenance approaches | May consider stopping after amyloid is reduced to minimal levels on PET |
What makes someone a good candidate?
In real clinical practice, eligibility is more than “has memory issues.” Many centers use a step-by-step approach to protect safety and
match treatment to the patients most likely to benefit.
Common requirements
- Early symptomatic stage: MCI due to Alzheimer’s or mild Alzheimer’s dementia.
- Confirmed amyloid pathology: usually amyloid PET or CSF testing.
- MRI compatibility: because monitoring depends on MRI imaging.
- Risk review: history of brain bleeding, stroke risks, and certain medications may affect suitability.
APOE ε4 testing: helpful, not destiny
APOE ε4 status doesn’t decide your future like a villain in a superhero movie. But it can meaningfully affect ARIA risk with this drug class.
Many clinicians recommend APOE ε4 testing so patients and families can make an informed decision with eyes wide open.
Costs, coverage, and the “healthcare logistics” reality
The science is only half the story. The other half is: can you realistically access and sustain treatment?
Anti-amyloid therapy often involves infusion visits (at least initially), MRI appointments, specialist follow-up, and sometimes PET imaging.
Medicare coverage (and why paperwork suddenly becomes a hobby)
Medicare coverage for anti-amyloid monoclonal antibodies has been tied to Coverage with Evidence Development (CED)meaning treatment is
covered when patients meet criteria and data are collected through approved registries or studies. That policy has shaped how clinics
enroll patients, document eligibility, and coordinate care.
Bottom line: many people do receive coverage, but they also encounter a system that demands eligibility documentation, consistent monitoring,
and structured follow-up. For families, it can feel like Alzheimer’s care plus a part-time job in scheduling.
What to ask a neurologist or memory clinic
If you’re considering either medication, these questions can turn a confusing appointment into a clear decision pathway:
- Am I (or is my loved one) in the stage these drugs were studied?
- How will we confirm amyloid? (PET, CSF, or another accepted method)
- What is our ARIA risk? Would APOE ε4 testing help our decision?
- What’s the MRI schedule? Where will MRIs be done, and how fast can results be reviewed?
- What symptoms should trigger an urgent call?
- How do you handle side effects? (Dose holds, extra imaging, ER guidance)
- What will insurance cover, and what will we pay?
Important safety note (non-negotiable)
This is educational information, not personal medical advice. These medications can carry serious risks and require careful selection and monitoring.
If you suspect Alzheimer’s disease or are exploring treatment, a clinician experienced in dementia care is the safest guide.
If urgent neurological symptoms occur (sudden confusion, new weakness, severe headache, seizures), seek emergency care.
: Real-world experiences families commonly report
Even when the science is clear, the lived experience is messyin a very human way. Families often describe the start of anti-amyloid treatment as a
strange combination of hope, caution, and calendar anxiety. Hope, because “we can do something” feels radically different from “we’ll watch and wait.”
Caution, because the consent discussions are detailed, and the side effects are not the kind you shrug off with ginger tea. And calendar anxiety,
because you suddenly have recurring appointments that could make a small airline jealous.
Many patients first arrive at this decision after months (or years) of subtle changes: repeating questions, getting lost on familiar routes, struggling
with finances or cooking steps, or feeling “off” in a way that’s hard to name. When testing confirms amyloid, families often feel a complicated relief.
It’s not good newsbut it is an answer. That answer opens doors to planning, services, and (for some) treatment.
Infusion day itself tends to become a routine. People pack snacks, chargers, and something comforting to dobecause sitting in a chair with an IV,
even in a friendly clinic, is still sitting in a chair with an IV. Some patients feel fine afterward; others report fatigue or flu-like symptoms.
Caregivers often learn to schedule lighter days after infusions “just in case,” especially early on.
The MRI schedule can feel like the emotional centerpiece. Families frequently describe a quiet tension in the days between the scan and the results,
because ARIA can be present without symptoms. When MRIs are normal, the relief is real. When there are changes, even mild ones, the experience can be
unsettling: dose holds, follow-up imaging, and careful monitoring can interrupt the “we’re finally doing something” momentum. That doesn’t necessarily
mean treatment endsit often means the team is doing what it’s supposed to do: catching safety issues early and responding thoughtfully.
Over time, many caregivers judge benefit less by test scores and more by everyday life: “Is she still making her own breakfast?” “Can he still manage
the remote without turning on the subtitles for the dog documentary?” “Are we having more good mornings than bad ones?” Because the goal isn’t perfection.
It’s preserving independence, routines, and connection for as long as possible.
Finally, families commonly emphasize that these medications don’t replace the basics. The best experiences usually happen when drug therapy is paired
with comprehensive care: managing blood pressure and diabetes, treating depression, improving sleep, supporting hearing and vision, building safe routines,
and getting caregiver help early instead of heroically late. In other words: the medication can be one important toolbut the “whole toolbox” is what
makes day-to-day life better.
Conclusion
Yesthere may be two FDA-approved medications that can slow Alzheimer’s disease progression in the early stages: Leqembi (lecanemab) and Kisunla (donanemab).
They represent a real shift toward disease-modifying treatment, but they come with real-world complexity: careful patient selection, confirmed amyloid,
MRI monitoring for ARIA, and practical planning around infusion and follow-up care. For the right patient, the payoff can be meaningful timemore months of
function, routine, and independence. The best next step is a specialized evaluation at a memory clinic or with a neurologist who can match the evidence
to the individual.
