Could New Alzheimer’s Treatments Help You or a Loved One Stay Independent Longer? What to Know in 2025

In 2025, the most significant advancement in treating Alzheimer’s disease in the United States is the approval of Kisunla (donanemab-azbt) by the FDA in July 2024.

Kisunla, along with Leqembi (lecanemab), offers a new approach through anti-amyloid monoclonal antibody therapies. These therapies have been found to slow—but not cure—disease progression in adults at the earliest symptomatic stages of Alzheimer’s. They have demonstrated measurable, although modest, benefits and carry notable safety risks. Use of these drugs is limited to select patient groups based on specific criteria.

Understanding Kisunla (Donanemab) Approval and Its Mechanism

Kisunla is approved for adults with early symptomatic Alzheimer’s disease, including those with mild cognitive impairment or mild dementia. It is not intended for individuals with moderate or late-stage Alzheimer’s, and it does not restore lost memory or function. As an anti-amyloid monoclonal antibody, Kisunla is designed to bind to and promote the removal of amyloid plaques—protein clusters in the brain that are associated with Alzheimer’s progression.

Administration and Treatment Duration

Infusion: Kisunla is administered through intravenous infusion in a medical setting.
Schedule: Treatment begins with 700 mg infusions every four weeks for the first three doses, followed by 1400 mg every four weeks.
Personalized Duration: Treatment may continue for up to 72 weeks (approximately 18 months), though periodic PET brain scans may indicate whether therapy can be stopped earlier if sufficient amyloid reduction is observed. Some clinical trial participants completed treatment in six months.
Monitoring: Ongoing brain imaging (often MRI) is necessary to monitor for potential side effects.

Eligibility Criteria for Current Alzheimer’s Therapies

To be considered for these therapies, patients generally need to meet the following criteria:

Mild Cognitive Impairment or Mild Dementia Stage: Approval is limited to individuals in the early stages of Alzheimer’s, as reflected in clinical studies.
Evidence of Amyloid Pathology: Confirmation of amyloid plaques through PET imaging is required.
Genetic Factors: Testing for the APOE-4 gene is recommended because people with two copies face a higher risk for certain side effects.
Specialist Evaluation: Decisions about therapy are guided by a specialist team who will evaluate the balance of potential benefits and risks.

What to Know About Expected Outcomes

Kisunla and Leqembi are not curative and do not reverse the effects of Alzheimer’s disease. Rather, these drugs have demonstrated the ability to modestly slow cognitive and functional decline.

Findings from Clinical Trials

Slower Decline: Kisunla was associated with a 22–35% slower decline in memory and everyday abilities compared to placebo after approximately 18 months of treatment.
Functional Differences: In clinical trials, people at the mild cognitive impairment stage maintained independence for an average of about eight months longer compared to those not treated with the drug, based on group averages. For those already requiring some assistance, the delay in reaching further dependence was measured at up to 19 months, also on average in the studied group.
No Recovery of Lost Abilities: Individuals in these studies did not regain previously lost skills, but some were able to maintain their level of functioning for a longer period.

Potential Impact on Daily Life

Reported benefits may include: - Extended time managing daily activities such as financial tasks, meal preparation, or driving. - Delayed need for assisted living or more intensive care support. - Additional time for planning among families and caregivers.

These effects are based on group averages from studies, and individual experiences will vary.

Safety, Side Effects, and the Need for Monitoring

Safety Profile and Noted Risks

All anti-amyloid antibodies, including Kisunla, carry a boxed warning for amyloid-related imaging abnormalities (ARIA):

ARIA: This includes risks of brain swelling or bleeding, sometimes presenting with symptoms such as headaches, confusion, or seizures; at other times, these changes are only detected through brain imaging.
- ARIA occurred in approximately 13–25% of participants in clinical trials.
- The risk is higher in individuals with two copies of the APOE-4 gene.
Infusion Reactions: These can include chills, nausea, changes in blood pressure, flushing, or shortness of breath.
Severe Allergic Reactions: Rare but potentially serious.

Monitoring and Screening Requirements

Genetic Testing: Screening for APOE-4 gene variants is recommended before starting therapy to assess ARIA risk.
Ongoing Imaging: Regular MRI scans are required for patient safety monitoring.
Specialist Oversight: This therapy is administered in centers with expertise in Alzheimer’s treatments.

A Look at Kisunla in Context with Other Treatments

Leqembi (lecanemab) is another recently approved therapy in the same class:

Infusion Frequency: Kisunla is administered once a month and may be stopped early based on amyloid clearance, while Leqembi is administered every two weeks and is typically continued indefinitely.
Treatment Duration: Kisunla treatment generally ranges from six to 18 months; Leqembi is usually given on an ongoing basis.
Costs: The list price for Kisunla is approximately $32,000 per year (total cost depends on duration); Leqembi’s list price is about $26,500 per year.
Monitoring: Both therapies require MRI scanning, and both have comparable risks for ARIA.

Access, Costs, and Insurance Considerations

Insurance Coverage: For eligible patients, Medicare typically covers 80% of drug and related costs after deductibles, provided treatment occurs at qualifying centers and data collection requirements are met. Medicaid and commercial insurance coverage can vary.
Patient Expenses: Out-of-pocket costs may reach several thousand dollars annually, depending on insurance details and the number of required infusions.
Access Barriers: Access to these therapies may be limited by the requirement for specialized infusion centers and frequent imaging, particularly in rural or under-resourced communities.
Available Options: As of 2025, there are no newly approved oral medicines for Alzheimer’s, nor FDA-approved therapies for moderate or late-stage disease outside of these infusion treatments.

Ongoing Limitations and Open Questions

Despite progress in 2025, certain limitations remain:

Not a Cure: These therapies have been shown to slow, but not stop or reverse, Alzheimer’s progression.
Potential Safety Concerns: There is a risk of ARIA and other serious reactions, though these remain uncommon.
Representation in Research: Clinical trials have primarily enrolled white, relatively healthy adults, and more data is needed on effects in diverse populations.
Cost and Accessibility: The financial burden and need for complex infrastructure may hinder widespread adoption.
Unknown Long-Term Impacts: Long-term safety and efficacy data are still being collected.

The Role of Shared Decision-Making

Choosing whether to start Kisunla or a similar therapy involves:

Detailed discussions with healthcare providers who specialize in memory and dementia care.
Assessing medical eligibility, individual goals, willingness to accept risks, and the feasibility of ongoing medical monitoring and costs.
Including caregivers in planning and decision-making processes for comprehensive support.

In 2025, Kisunla and Leqembi represent significant developments for early-stage Alzheimer’s treatment in the US. These therapies may help eligible individuals maintain independence for longer periods but require careful evaluation, monitoring, and ongoing specialist involvement. The decision to use these treatments is highly individualized, with ongoing research expected to further inform their long-term role in care.

Sources

Disclaimer: All content, including text, graphics, images and information, contained on or available through this web site is for general information purposes only. The information and materials contained in these pages and the terms, conditions and descriptions that appear, are subject to change without notice.

Lifestyle