The newest FDA-approved treatments for Alzheimer’s disease represent a genuine turning point in how medicine approaches the condition. For the first time, patients and families have access to therapies that do more than manage symptoms — they target the underlying biology of the disease itself. As of early 2026, two drugs have received full FDA approval for slowing Alzheimer’s progression: lecanemab (brand name Leqembi), approved in July 2023 and since expanded with new dosing options, and donanemab (Kisunla), approved in July 2024.
Both work by clearing beta-amyloid plaques from the brain and are intended for people in the early stages of the disease — mild cognitive impairment or mild dementia with confirmed amyloid buildup. This article walks through what these treatments are, how they differ, who qualifies, what the risks look like, and how the older generation of Alzheimer’s drugs fits into the picture. It also covers the practical shifts happening right now — including a new self-injectable form of lecanemab approved in August 2025 that patients can administer at home — and what’s coming down the pipeline in the months ahead.
Table of Contents
- What Are the Newest FDA-Approved Treatments for Alzheimer’s Disease?
- How Does Lecanemab (Leqembi) Work and What’s Changed Recently?
- What Is Donanemab (Kisunla) and How Does It Compare to Leqembi?
- Who Qualifies for These New Alzheimer’s Treatments — and Who Doesn’t?
- What Are the Safety Risks of the New Anti-Amyloid Drugs?
- Where Do the Older Alzheimer’s Drugs Fit In Now?
- What’s Next in Alzheimer’s Treatment?
- Conclusion
- Frequently Asked Questions
What Are the Newest FDA-Approved Treatments for Alzheimer’s Disease?
The two newest FDA-approved Alzheimer’s treatments are lecanemab (Leqembi) and donanemab (Kisunla). Both belong to a class called anti-amyloid monoclonal antibodies. The core idea behind them is that Alzheimer’s disease is driven in part by the accumulation of beta-amyloid protein into plaques between neurons. These drugs bind to and help clear those plaques, with the goal of slowing how fast the disease progresses — not reversing damage already done, but buying time. Lecanemab, developed by Eisai and Biogen, received its original FDA approval in July 2023 under the accelerated pathway, then full traditional approval later that same year. Donanemab, developed by Eli Lilly, followed with full approval on July 2, 2024.
In clinical trials, donanemab showed approximately 35% slower disease progression over 18 months compared to placebo — translating to roughly a 4.5 to 7.5 month delay on clinical measurement scales. These numbers sound modest, but for families watching a loved one decline, slowing that decline even partially carries real weight. It’s worth being precise about what “approved for early Alzheimer’s” means. These drugs are not for people in the moderate or severe stages of the disease. They are for individuals who still have mild symptoms — people who may be having memory problems and functional difficulties but can still live relatively independently. Diagnosis must be confirmed with evidence of amyloid plaques, typically through a PET scan or spinal fluid analysis, which adds both cost and complexity to who can realistically access them.
How Does Lecanemab (Leqembi) Work and What’s Changed Recently?
Lecanemab targets a specific form of amyloid aggregation called protofibrils, which are thought to be particularly toxic to neurons. It binds to these structures and triggers their clearance through the immune system. When it was first approved, the treatment required an intravenous infusion every two weeks — a significant time and logistics burden for patients, many of whom are elderly and may not live near major medical centers. That changed in January 2026, when the FDA approved a maintenance dosing schedule allowing infusions every four weeks instead of two, after an initial treatment period. Then, more significantly, on August 29, 2025, the FDA approved LEQEMBI IQLIK — a subcutaneous formulation that patients or caregivers can self-inject at home once weekly.
This is a substantial shift. Instead of arranging transportation to an infusion clinic, sitting for an IV, and building a biweekly schedule around appointments, eligible patients can administer the drug themselves. For people in rural areas or those with limited mobility, this changes the practical calculus of treatment considerably. Looking further ahead, Eisai has filed a supplemental application for a subcutaneous autoinjector that would also cover the starting dose — not just the maintenance phase. The FDA accepted that application under Priority Review, with a decision expected by May 24, 2026. If approved, the entire lecanemab treatment course could eventually be manageable without a single IV infusion.
What Is Donanemab (Kisunla) and How Does It Compare to Leqembi?
Donanemab, sold as Kisunla, takes a somewhat different approach. It also targets amyloid plaques, but it specifically binds to a modified form of amyloid called pyroglutamate amyloid, which is found in more mature plaques. One notable feature of donanemab’s trial design was that treatment was discontinued in patients whose amyloid burden dropped below a certain threshold — suggesting the drug could be used on a finite course rather than indefinitely. This is a meaningful distinction from lecanemab, which currently requires ongoing administration. In practice, donanemab is given as a once-monthly IV infusion, compared to lecanemab’s original biweekly schedule. For patients weighing the burden of treatment, once monthly is considerably easier to manage.
The approval was specifically for early symptomatic Alzheimer’s in patients with confirmed amyloid plaques, mirroring lecanemab’s indication. However, the clinical trial population for donanemab included a specific analysis showing that patients with lower levels of another protein called tau — a marker of neurodegeneration — had more robust responses to the drug. For families trying to choose between the two, there is no direct head-to-head trial. The comparison has to be made across separate studies with somewhat different populations and endpoints. Physicians will typically consider individual patient factors: amyloid load, tau burden, tolerance for infusion frequency, access to monitoring, and the availability of the drug through insurance. Both carry a similar safety profile, which brings up a critical point about what monitoring these treatments require.
Who Qualifies for These New Alzheimer’s Treatments — and Who Doesn’t?
Qualifying for lecanemab or donanemab is not simply a matter of having an Alzheimer’s diagnosis. The eligibility criteria are specific and the screening process is involved. Candidates must be in the early symptomatic phase — mild cognitive impairment or mild Alzheimer’s dementia — and must have amyloid confirmed in the brain. This typically requires either a PET scan or a cerebrospinal fluid analysis through a lumbar puncture. Neither test is routine, and PET scans for amyloid are expensive and not universally covered by insurance, though Medicare has expanded coverage for amyloid PET in the context of these treatment decisions. There are also exclusion criteria that eliminate some patients entirely.
People taking blood thinners have an elevated risk of the serious bleeding complications associated with these drugs. Patients who carry two copies of the APOE4 gene — a major genetic risk factor for Alzheimer’s — face higher rates of brain swelling and bleeding on these drugs, and some physicians are cautious about treating them, or require additional informed consent and monitoring protocols. Individuals with certain cardiovascular conditions or prior strokes may also be excluded depending on clinical judgment. The practical reality is that many Alzheimer’s patients will not qualify, either because they are diagnosed too late, lack access to the required diagnostic imaging, or have complicating medical factors. A person whose diagnosis comes at the moderate stage has already missed the window these drugs are designed for. This is one reason why earlier diagnosis and broader access to amyloid testing matters more than ever — the drugs are only useful if patients can reach them in time.
What Are the Safety Risks of the New Anti-Amyloid Drugs?
Both lecanemab and donanemab carry a significant and well-documented safety concern called ARIA — Amyloid-Related Imaging Abnormalities. ARIA comes in two forms: ARIA-E involves fluid and swelling in the brain (edema), while ARIA-H involves small bleeds (microhemorrhages and superficial siderosis). Many cases of ARIA are asymptomatic and detected only on the required MRI monitoring scans. But in some patients, ARIA produces symptoms including headaches, dizziness, visual disturbances, nausea, confusion, and in rare cases, more serious neurological events. In clinical trials, ARIA occurred in a substantial proportion of treated patients. With donanemab, approximately 24% of patients experienced ARIA-E, and 31% experienced ARIA-H of any severity. Most resolved without permanent consequences, but a small number of patients in trials experienced serious or life-threatening events.
Three deaths in the donanemab trial were considered possibly related to ARIA, though causality in individual cases is difficult to establish definitively. These figures are not hidden — they are part of the prescribing information — but they require frank conversation between physicians and patients before starting treatment. Because of these risks, both drugs require regular MRI monitoring, particularly in the early phase of treatment. This adds another logistical layer. Patients must have access to MRI facilities and must adhere to the monitoring schedule. If ARIA is detected, dosing may be paused or stopped depending on severity. This is not a set-it-and-forget-it treatment; it demands active medical partnership throughout the course of therapy.
Where Do the Older Alzheimer’s Drugs Fit In Now?
The arrival of anti-amyloid therapies does not make the older generation of Alzheimer’s drugs obsolete. Cholinesterase inhibitors — donepezil, rivastigmine, and galantamine — remain in wide use across all stages of Alzheimer’s. They work by inhibiting the breakdown of acetylcholine, a neurotransmitter involved in memory and cognition, which helps manage symptoms even if they don’t touch the underlying disease process.
Memantine, approved for moderate to severe Alzheimer’s, works through a different mechanism involving glutamate regulation and can be used alone or in combination with cholinesterase inhibitors. These drugs are often the first line of treatment for newly diagnosed patients, particularly those who don’t meet criteria for the anti-amyloid therapies. For patients with moderate or severe disease — the majority of people living with Alzheimer’s — the older drugs remain the only approved pharmacological options available. A person diagnosed years ago who has progressed beyond the early stage is not a candidate for lecanemab or donanemab, but may still benefit meaningfully from donepezil or memantine in terms of day-to-day function and quality of life.
What’s Next in Alzheimer’s Treatment?
The period from 2023 to 2026 has been the most active in Alzheimer’s drug approval history, and the momentum shows no sign of stopping. Beyond the pending May 2026 decision on lecanemab’s subcutaneous starter dose, researchers are exploring next-generation approaches including anti-tau therapies, combination treatments, and drugs aimed at inflammation and synaptic protection. The amyloid hypothesis has driven the current wave of approvals, but many researchers believe targeting tau — which accumulates inside neurons as tangles — will be necessary to achieve more substantial disease modification.
There is also broader work underway to make existing approved treatments more accessible. The shift toward subcutaneous dosing and home administration is as much about healthcare system capacity as it is convenience — infusion centers face real constraints, and a treatment that can be given at home reduces those bottlenecks. Genetic and biomarker-based patient selection continues to refine who is most likely to benefit, which should improve outcomes over time as clinical practice matures around these new drugs.
Conclusion
The Alzheimer’s treatment landscape has changed more in the past three years than in the preceding two decades. Lecanemab and donanemab represent the first approved therapies that can meaningfully slow the disease’s progression, not just manage its symptoms. Lecanemab in particular has expanded rapidly, moving from biweekly IV infusions to monthly maintenance dosing and now a once-weekly home injection, with further delivery options pending in 2026. Donanemab offers a once-monthly alternative with its own distinct clinical profile.
Neither is a cure, and neither is appropriate for everyone — but for patients caught early, they represent a real clinical option that did not exist a few years ago. For families navigating these decisions, the most important steps are early diagnosis and a frank conversation with a neurologist who specializes in memory disorders. Amyloid confirmation, genetic testing for APOE4, and a thorough review of medical history are all part of determining whether these treatments are viable. The older symptomatic drugs remain valuable tools as well, particularly for the many patients who don’t qualify for the newer therapies. This is a field moving quickly, and staying informed — through physicians, Alzheimer’s research centers, and reputable patient advocacy organizations — is increasingly part of managing the disease.
Frequently Asked Questions
Are lecanemab and donanemab covered by Medicare?
Medicare has expanded coverage for these drugs following their traditional FDA approval, including coverage for the required amyloid PET scans in the context of treatment decisions. However, coverage details, copays, and prior authorization requirements vary, and patients should verify with their specific Medicare plan or supplemental insurer.
Can someone in the moderate stage of Alzheimer’s start one of these new treatments?
No. Both lecanemab and donanemab are approved specifically for early symptomatic Alzheimer’s — mild cognitive impairment or mild dementia. Patients who have progressed to moderate or severe stages are not eligible candidates for these drugs.
What does it mean to have amyloid “confirmed” before starting treatment?
Confirmation typically requires either a PET scan that shows amyloid plaques in the brain, or a lumbar puncture (spinal tap) to analyze cerebrospinal fluid for amyloid and tau protein levels. A standard clinical diagnosis of Alzheimer’s is not sufficient on its own for these therapies.
How serious is ARIA, and should it prevent someone from trying these drugs?
ARIA ranges from asymptomatic findings on MRI to, in rare cases, serious neurological events. Most cases are mild and resolve with monitoring or temporary dose pauses. However, people with certain risk factors — such as two copies of the APOE4 gene or those on blood thinners — face higher risk and should discuss this carefully with their neurologist before starting treatment.
Is the subcutaneous form of lecanemab (LEQEMBI IQLIK) available now?
Yes. The FDA approved the once-weekly subcutaneous self-injection formulation of lecanemab on August 29, 2025. A separate autoinjector for the starting dose is still under FDA review, with a decision expected May 24, 2026.
Do these new drugs work for all types of dementia?
No. Lecanemab and donanemab are specifically approved for Alzheimer’s disease with confirmed amyloid pathology. They are not approved or indicated for other forms of dementia such as vascular dementia, Lewy body dementia, or frontotemporal dementia.
