Donanemab is a monoclonal antibody for the treatment of early-stage Alzheimer’s disease, marketed under the brand name Kisunla®.

This medication specifically targets certain forms of beta-amyloid found in plaques that accumulate in the brain and promotes their removal. In this way, Donanemab aims to modify the course of the disease and slow cognitive and functional decline, rather than acting solely on its symptoms.

Kisunla® is authorised in Europe for adult patients with mild cognitive impairment or mild dementia due to Alzheimer’s disease, with confirmed amyloid pathology, who have no copies or only one copy of the ApoE ε4 allele.

For this reason, not everyone with Alzheimer’s disease can receive Donanemab. Before starting treatment, a specialist assessment is essential to confirm the diagnosis and determine whether the patient meets the established clinical, biological and safety criteria.

This new medication for Alzheimer’s disease is specifically indicated for certain patients who are in the early symptomatic stages of the disease and have confirmed beta-amyloid accumulation.

The indication for Kisunla® in Europe also depends on ApoE genotype: it may be given to patients who are non-carriers of ApoE ε4 or who have a single copy of this allele. Therefore, genetic testing forms part of the assessment before treatment.

Among other aspects, the assessment prior to treatment with Donanemab makes it possible to:

· Confirm that the patient has mild cognitive impairment or mild dementia due to Alzheimer’s disease.

· Confirm the presence of beta-amyloid pathology using a validated test.

· Determine the ApoE ε4 genotype.

· Perform a brain MRI to identify potential risk factors or contraindications.

· Assess the patient’s medical history, current medication and other factors that may affect the safety of treatment.

Appropriate patient selection is essential to determine whether Donanemab is indicated and to individually assess the balance between its potential benefits and risks.

Kisunla® (donanemab) is administered by intravenous infusion once every four weeks in a healthcare setting and under the supervision of professionals experienced in the diagnosis and treatment of Alzheimer’s disease.

One characteristic of this treatment is that its duration is linked to the clearance of beta-amyloid plaques. Treatment may be continued until their clearance is confirmed using a validated test, with a maximum treatment duration of 18 months.

The Donanemab dosing regimen involves a gradual increase in dose during the first few months: 350 mg is administered for the first dose, 700 mg for the second, 1,050 mg for the third, followed by 1,400 mg every four weeks.

Treatment also requires a specific monitoring protocol using brain MRI scans. In addition to having a recent MRI scan before starting treatment, follow-up scans are performed before certain doses during the first few months, when monitoring for potential adverse effects is particularly important. These include amyloid-related imaging abnormalities (ARIA), which can cause brain swelling or small areas of bleeding in the brain. Specialist monitoring enables these abnormalities to be detected and, when necessary, treatment to be interrupted, modified or discontinued.

What does Alzheimer’s treatment with Donanemab involve?

Treatment with Donanemab (Kisunla®) involves much more than the periodic administration of a medication. Patient selection, confirmation of the diagnosis, monitoring of amyloid burden and surveillance for potential adverse effects require a specialised and coordinated approach throughout the entire treatment process.

Are Donanemab and Kisunla® the same?

Yes. Donanemab is the active substance and Kisunla® is the brand name of the medication. Therefore, both terms refer to the same treatment for Alzheimer’s disease.

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Is Donanemab approved in Spain?

Yes. Kisunla® (donanemab) has had a valid marketing authorisation in the European Union since September 2025, meaning that it is also authorised in Spain for the indication and patient population established by the European health authorities.

Its authorisation does not necessarily mean that the medication is already available at all centres. barnaclínic+ plans to introduce Donanemab shortly and can provide interested patients with information about its availability and assess whether they meet the criteria for treatment.

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Is Donanemab funded by the Spanish National Health System?

Currently, Kisunla® is not funded by the Spanish National Health System (SNS). This should not be confused with its authorisation: Donanemab has European authorisation for certain patients with early-stage Alzheimer’s disease, but it is not currently included in public funding through the SNS.

At barnaclínic+, you can request information about private access to Donanemab in Spain, its availability and the process required to determine whether a patient may be eligible for treatment.

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Does Donanemab cure Alzheimer’s disease?

No. Donanemab does not cure Alzheimer’s disease or restore cognitive abilities that have already been lost. Its aim is to modify the course of the disease and slow its progression in certain patients with early-stage Alzheimer’s disease.

For this reason, early diagnosis and the appropriate identification of potential candidates are particularly important.

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What is the mechanism of action of Donanemab?

Donanemab is a monoclonal antibody that binds to beta-amyloid found in plaques in the brain. This binding promotes the activation of microglial cells, which help remove amyloid deposits.

The reduction of these plaques is the mechanism through which Kisunla® aims to slow the cognitive and functional decline associated with Alzheimer’s disease.

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What is the dose of Donanemab?

Treatment uses a gradual dose escalation of Donanemab. The European dosing regimen establishes 350 mg for the first administration, 700 mg for the second and 1,050 mg for the third. Thereafter, 1,400 mg is administered every four weeks.

The doses are administered by intravenous infusion and treatment must be given under specialist medical supervision.

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How long does Donanemab treatment last?

Donanemab treatment has a maximum duration of 18 months, although it may be stopped earlier if amyloid plaque clearance is confirmed according to the established criteria.

This allows the duration of treatment to be adapted to each patient’s biological response, always under the assessment of the specialist team.

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What tests are required before starting Donanemab?

Before starting treatment, it is necessary to confirm the diagnosis of Alzheimer’s disease and the presence of amyloid pathology, determine the ApoE genotype and have a recent brain MRI scan.

The patient’s medical history, current medication and other potential risk factors must also be assessed to determine whether Kisunla® is indicated and can be administered safely.

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What monitoring is required during treatment?

Donanemab treatment requires particularly intensive monitoring with brain MRI scans during the first few months. The European product information establishes MRI monitoring before the second, third, fourth and seventh doses, as well as additional scans when clinically indicated.

The main objective is the early detection of potential amyloid-related imaging abnormalities (ARIA).

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What are the possible side effects of Donanemab?

Among the side effects of Donanemab that require particular monitoring are amyloid-related imaging abnormalities (ARIA), which may include brain swelling and small areas of bleeding in the brain. Infusion-related reactions and other adverse effects may also occur.

Some ARIA abnormalities may not cause symptoms, which is why follow-up MRI scans are a fundamental part of the Kisunla® safety monitoring protocol.

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How much does Donanemab cost in Spain?

The cost of Donanemab treatment in Spain should be assessed by considering the entire care pathway rather than the medication alone. The initial assessment, diagnostic tests, intravenous infusions, duration of treatment, and medical and neuroimaging monitoring all form part of the treatment process.

barnaclínic+ will provide a Treatment Plan with information about Donanemab treatment, which you will be able to request through this page.

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Can you buy Donanemab in Spain?

Donanemab is not a medication that can be purchased directly for administration at home. Kisunla® is a prescription medication and is administered by intravenous infusion under medical supervision.

In addition, before accessing the medication, a specialist must determine whether the patient meets the established clinical, biological, genetic and safety criteria for treatment.