FDA-Approved Treatments for Alzheimer’s Disease

New FDA Approved Alzheimer’s Treatments

Recent Updates and Regulatory Approvals

The U.S. Food and Drug Administration (FDA) has approved several medications for the treatment of individuals with early-stage Alzheimer’s disease. Below are recent updates on FDA-approved therapies, including information on indications, administration, clinical trial findings, and important safety considerations. These summaries are provided for educational purposes and are not a substitute for medical advice.

April 30, 2026 – FDA Approves Dextromethorphan-bupropion (Auvelity) for Management of Agitation

Alzheimer’s Disease has far-reaching consequences that go beyond cognitive impairment and may be associated with neuropsychological signs including agitation. Agitation in Alzheimer’s Disease may present as excessive motor activity, verbal aggression, restlessness, pacing, and emotional lability. The impact of agitation on people with Alzheimer’s disease as well as families and caregivers can be considerable as it is often unpredictable and can escalate quickly.

Unfortunately, agitation in people with Alzheimer’s disease can also be difficult to manage and often contributes significantly to caregiver burden and reduced quality of life. While behavioral interventions remain the recommended first-line treatment for agitation in Alzheimer’s disease, medications are sometimes necessary when symptoms become severe or distressing. Recently, dextromethorphan-bupropion (sold under the trade name Auvelity) was approved by the U.S. Food & Drug Administration (FDA) for the treatment of agitation associated with Alzheimer’s disease, becoming the second FDA-approved medication for this purpose and the first non-antipsychotic option. The antipsychotic medication brexpiprazole (sold under the trade name Rexulti) is also FDA-approved for agitation in Alzheimer’s Disease.

Dextromethorphan-bupropion is a daily medication that requires gradual increase in dose over several weeks to reach an effective dose. It combines dextromethorphan, a compound that works on the brain’s N-methyl-D-aspartate (NMDA) and sigma-1 receptors, with the antidepressant drug bupropion, which increases the availability of dextromethorphan by inhibiting its metabolism. These combined effects are thought to influence neurotransmitter systems involved in mood, behavior, and emotional regulation. The FDA approval was based on randomized clinical trials that showed improvement in agitation symptoms on dextromethorphan-bupropion compared to placebo, as well as reduced risk of relapse among study participants who continued treatment compared to those who discontinued therapy.

Clinically, dextromethorphan-bupropion may represent an important alternative treatment option for patients in whom antipsychotic medications are contraindicated or poorly tolerated. Because it has a different mechanism of action from antipsychotics, dextromethorphan-bupropion may offer a safer or more tolerable option for patients who have experienced extrapyramidal symptoms, sedation, or other adverse effects related to antipsychotic therapy. Despite its potential advantages, dextromethorphan-bupropion still carries important safety considerations. It includes a boxed warning for antidepressant-associated suicidal thoughts and behaviors in young people, and it may lower seizure threshold, can increase blood pressure, and may precipitate mania or hypomania in susceptible patients, so thoughtful patient selection and monitoring remain important.

April 30, 2026 – FDA Approves Dextromethorphan-bupropion (Auvelity) for Management of Agitation

Alzheimer’s Disease has far-reaching consequences that go beyond cognitive impairment and may be associated with neuropsychological signs including agitation. Agitation in Alzheimer’s Disease may present as excessive motor activity, verbal aggression, restlessness, pacing, and emotional lability. The impact of agitation on people with Alzheimer’s disease as well as families and caregivers can be considerable as it is often unpredictable and can escalate quickly.

Unfortunately, agitation in people with Alzheimer’s disease can also be difficult to manage and often contributes significantly to caregiver burden and reduced quality of life. While behavioral interventions remain the recommended first-line treatment for agitation in Alzheimer’s disease, medications are sometimes necessary when symptoms become severe or distressing. Recently, dextromethorphan-bupropion (sold under the trade name Auvelity) was approved by the U.S. Food & Drug Administration (FDA) for the treatment of agitation associated with Alzheimer’s disease, becoming the second FDA-approved medication for this purpose and the first non-antipsychotic option. The antipsychotic medication brexpiprazole (sold under the trade name Rexulti) is also FDA-approved for agitation in Alzheimer’s Disease.

Dextromethorphan-bupropion is a daily medication that requires gradual increase in dose over several weeks to reach an effective dose. It combines dextromethorphan, a compound that works on the brain’s N-methyl-D-aspartate (NMDA) and sigma-1 receptors, with the antidepressant drug bupropion, which increases the availability of dextromethorphan by inhibiting its metabolism. These combined effects are thought to influence neurotransmitter systems involved in mood, behavior, and emotional regulation. The FDA approval was based on randomized clinical trials that showed improvement in agitation symptoms on dextromethorphan-bupropion compared to placebo, as well as reduced risk of relapse among study participants who continued treatment compared to those who discontinued therapy.

Clinically, dextromethorphan-bupropion may represent an important alternative treatment option for patients in whom antipsychotic medications are contraindicated or poorly tolerated. Because it has a different mechanism of action from antipsychotics, dextromethorphan-bupropion may offer a safer or more tolerable option for patients who have experienced extrapyramidal symptoms, sedation, or other adverse effects related to antipsychotic therapy. Despite its potential advantages, dextromethorphan-bupropion still carries important safety considerations. It includes a boxed warning for antidepressant-associated suicidal thoughts and behaviors in young people, and it may lower seizure threshold, can increase blood pressure, and may precipitate mania or hypomania in susceptible patients, so thoughtful patient selection and monitoring remain important.

August 29, 2025 – FDA Approves New Maintenance Options for Leqembi

The FDA approved new maintenance treatment options for Leqembi (lecanemab) for individuals with early Alzheimer’s disease who have completed 18 months of initial therapy.

Data from the CLARITY AD clinical trial and its open-label extension showed that stopping treatment led to gradual return of amyloid in the brain, while continuing treatment helped maintain amyloid reduction and clinical benefit.

On January 26, 2025, the FDA approved a maintenance schedule of IV Leqembi every 4 weeks following the initial every-2-week dosing period.

On August 29, the FDA approved LEQEMBI® IQLIK™, a once-weekly subcutaneous injection that can be self-administered at home. This option offers a more convenient alternative to IV infusion. Mild injection-site reactions (such as redness or itching) may occur.

As with all amyloid-targeting therapies, side effects such as brain swelling or bleeding (ARIA) can occur. These events are most common during the first six months of treatment and are not expected to increase during the maintenance phase. Rates of ARIA are similar between IV and subcutaneous formulations.

Individuals completing initial Leqembi treatment should discuss maintenance options with their clinician to review risks, benefits, and whether continued therapy is appropriate.

Updated prescribing information is available here.

Find updated prescribing information for maintenance treatment here.

August 29, 2025 – FDA Approves New Maintenance Options for Leqembi

The FDA approved new maintenance treatment options for Leqembi (lecanemab) for individuals with early Alzheimer’s disease who have completed 18 months of initial therapy.

Data from the CLARITY AD clinical trial and its open-label extension showed that stopping treatment led to gradual return of amyloid in the brain, while continuing treatment helped maintain amyloid reduction and clinical benefit.

On January 26, 2025, the FDA approved a maintenance schedule of IV Leqembi every 4 weeks following the initial every-2-week dosing period.

On August 29, the FDA approved LEQEMBI® IQLIK™, a once-weekly subcutaneous injection that can be self-administered at home. This option offers a more convenient alternative to IV infusion. Mild injection-site reactions (such as redness or itching) may occur.

As with all amyloid-targeting therapies, side effects such as brain swelling or bleeding (ARIA) can occur. These events are most common during the first six months of treatment and are not expected to increase during the maintenance phase. Rates of ARIA are similar between IV and subcutaneous formulations.

Individuals completing initial Leqembi treatment should discuss maintenance options with their clinician to review risks, benefits, and whether continued therapy is appropriate.

Updated prescribing information is available here.

Find updated prescribing information for maintenance treatment here.

July 2, 2024 – FDA Approves Donanemab (Kisunla™)

On July 2, 2024, the FDA approved donanemab, developed by Eli Lilly and marketed as Kisunla™, for individuals with early symptomatic Alzheimer’s disease, including mild cognitive impairment and mild dementia stages, with confirmed amyloid plaques.

Donanemab is an amyloid-targeting therapy administered as a once-monthly IV infusion. Clinical trial data showed approximately 35% slower disease progression over 18 months compared with placebo, corresponding to a 4.5–7.5 month delay on clinical scales. Amyloid plaque levels were reduced by an average of 61% at 6 months, 80% at 12 months, and 84% at 18 months.

Serious adverse events were uncommon but occurred slightly more often in the treatment group. Amyloid-related imaging abnormalities (ARIA) were observed and require regular MRI monitoring before and during treatment. ARIA is typically managed by stopping therapy but can be serious in rare cases.

Individuals interested in donanemab or other approved treatments should consult their healthcare provider to determine eligibility and appropriateness.

The Cleveland Alzheimer’s Disease Research Center (CADRC) supports continued therapeutic development. For more information, contact contact@clevelandadrc.org
or 1-833-311-2372.

July 2, 2024 – FDA Approves Donanemab (Kisunla™)

On July 2, 2024, the FDA approved donanemab, developed by Eli Lilly and marketed as Kisunla™, for individuals with early symptomatic Alzheimer’s disease, including mild cognitive impairment and mild dementia stages, with confirmed amyloid plaques.

Donanemab is an amyloid-targeting therapy administered as a once-monthly IV infusion. Clinical trial data showed approximately 35% slower disease progression over 18 months compared with placebo, corresponding to a 4.5–7.5 month delay on clinical scales. Amyloid plaque levels were reduced by an average of 61% at 6 months, 80% at 12 months, and 84% at 18 months.

Serious adverse events were uncommon but occurred slightly more often in the treatment group. Amyloid-related imaging abnormalities (ARIA) were observed and require regular MRI monitoring before and during treatment. ARIA is typically managed by stopping therapy but can be serious in rare cases.

Individuals interested in donanemab or other approved treatments should consult their healthcare provider to determine eligibility and appropriateness.

The Cleveland Alzheimer’s Disease Research Center (CADRC) supports continued therapeutic development. For more information, contact contact@clevelandadrc.org
or 1-833-311-2372.

January 2023 – FDA Grants Accelerated Approval to Lecanemab (Leqembi®)

On January 6, 2023, the FDA approved lecanemab (Leqembi®) under the Accelerated Approval Program for individuals with mild cognitive impairment or mild dementia due to Alzheimer’s disease, based on amyloid reduction shown in the CLARITY AD trial.

In a study of nearly 1,800 participants, lecanemab slowed cognitive decline by 27% over 18 months compared with placebo. Approval was based on biomarker evidence, with continued studies required to confirm clinical benefit.

Amyloid-related imaging abnormalities (ARIA), including brain swelling or microbleeds, occurred in approximately 1 in 5 patients, highlighting the need for close clinical monitoring.

Patients considering lecanemab should discuss potential benefits and risks with their clinician, as responses and eligibility vary.

January 2023 – FDA Grants Accelerated Approval to Lecanemab (Leqembi®)

On January 6, 2023, the FDA approved lecanemab (Leqembi®) under the Accelerated Approval Program for individuals with mild cognitive impairment or mild dementia due to Alzheimer’s disease, based on amyloid reduction shown in the CLARITY AD trial.

In a study of nearly 1,800 participants, lecanemab slowed cognitive decline by 27% over 18 months compared with placebo. Approval was based on biomarker evidence, with continued studies required to confirm clinical benefit.

Amyloid-related imaging abnormalities (ARIA), including brain swelling or microbleeds, occurred in approximately 1 in 5 patients, highlighting the need for close clinical monitoring.

Patients considering lecanemab should discuss potential benefits and risks with their clinician, as responses and eligibility vary.

June 2021 – FDA Approves Aducanumab (Aduhelm®) Under Accelerated Approval

On June 7, 2021, the FDA approved aducanumab (Aduhelm®) for Alzheimer’s disease through the Accelerated Approval Program. Aducanumab was shown to reduce amyloid plaques in the brain, a hallmark of Alzheimer’s disease, though its impact on symptoms and daily functioning remains under study.

Aducanumab is administered via IV infusion every four weeks and is intended only for individuals with mild cognitive impairment or mild dementia due to Alzheimer’s disease. It is not indicated for other forms of dementia.

ARIA was the most common side effect observed in clinical trials, requiring regular MRI monitoring during treatment. Access and clinical use required extensive coordination among clinicians, imaging services, and insurers.

Individuals and families were encouraged—and continue to be encouraged—to discuss appropriateness with a clinician experienced in Alzheimer’s disease care.

Who May Be Eligible for Aducanumab

Aducanumab should only be initiated in individuals with mild cognitive impairment or mild dementia due to Alzheimer’s disease, the population studied in clinical trials. It is not indicated for other types of dementia.

Treatment requires a prescription and close clinical monitoring by clinicians experienced in Alzheimer’s disease care. Whether aducanumab is appropriate depends on individual clinical factors and should be determined in consultation with a treating clinician.

Safety Considerations

Like all medications, aducanumab has potential side effects. The most common observed during clinical trials were amyloid-related imaging abnormalities (ARIA), which may include brain swelling or small areas of bleeding. Because of this risk, regular MRI monitoring is required during treatment.

Determining If Aducanumab Is Right for You

Aducanumab is administered via intravenous infusion every four weeks, a more complex process than previous Alzheimer’s treatments. Evaluation typically includes confirmation of amyloid plaques and assessment of disease stage.

Patients and families are encouraged to speak with their healthcare providers to determine whether aducanumab is an appropriate option based on individual circumstances, risks, and potential benefits.

June 2021 – FDA Approves Aducanumab (Aduhelm®) Under Accelerated Approval

On June 7, 2021, the FDA approved aducanumab (Aduhelm®) for Alzheimer’s disease through the Accelerated Approval Program. Aducanumab was shown to reduce amyloid plaques in the brain, a hallmark of Alzheimer’s disease, though its impact on symptoms and daily functioning remains under study.

Aducanumab is administered via IV infusion every four weeks and is intended only for individuals with mild cognitive impairment or mild dementia due to Alzheimer’s disease. It is not indicated for other forms of dementia.

ARIA was the most common side effect observed in clinical trials, requiring regular MRI monitoring during treatment. Access and clinical use required extensive coordination among clinicians, imaging services, and insurers.

Individuals and families were encouraged—and continue to be encouraged—to discuss appropriateness with a clinician experienced in Alzheimer’s disease care.

Who May Be Eligible for Aducanumab

Aducanumab should only be initiated in individuals with mild cognitive impairment or mild dementia due to Alzheimer’s disease, the population studied in clinical trials. It is not indicated for other types of dementia.

Treatment requires a prescription and close clinical monitoring by clinicians experienced in Alzheimer’s disease care. Whether aducanumab is appropriate depends on individual clinical factors and should be determined in consultation with a treating clinician.

Safety Considerations

Like all medications, aducanumab has potential side effects. The most common observed during clinical trials were amyloid-related imaging abnormalities (ARIA), which may include brain swelling or small areas of bleeding. Because of this risk, regular MRI monitoring is required during treatment.

Determining If Aducanumab Is Right for You

Aducanumab is administered via intravenous infusion every four weeks, a more complex process than previous Alzheimer’s treatments. Evaluation typically includes confirmation of amyloid plaques and assessment of disease stage.

Patients and families are encouraged to speak with their healthcare providers to determine whether aducanumab is an appropriate option based on individual circumstances, risks, and potential benefits.

Looking for More Info on Dementia and Alzheimer’s Disease?

contact@clevelandadrc.org

Looking for More Info on Dementia and Alzheimer’s Disease?

contact@clevelandadrc.org

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