Brain Health & Memory

Kisunla (Donanemab) for Treating Alzheimer’s Disease

A new medication for the treatment of Alzheimer’s disease called donanemab (branded Kisunla) has been approved by the FDA and is being offered to patients at University Hospitals. Donanemab has shown significant promise in clinical trials and may be a treatment option for patients with mild cognitive impairment and mild dementia due to Alzheimer’s disease.

Talk to Your Neurologist

If you or a loved one have been diagnosed with Alzheimer’s disease, ask your neurologist if donanemab might be an appropriate treatment option.

Find a Doctor

For more information on the Donanemab infusion program, call Rebecca DiFranco at 216-464-6203.

Donanemab is not a cure for Alzheimer’s disease, and there is no evidence this or any other treatment can restore or reverse lost memories or cognitive function. However, in eligible patients, donanemab may slow progression of the disease, enhance their ability to participate in daily life and allow them to live independently longer.

How Does Donanemab Work?

People with Alzheimer’s disease have an abnormal buildup of plaques in their brain that contain a protein called beta-amyloid. Donanemab is an intravenous medication designed to target and remove these plaques.

The second drug therapy after Lecanemab to obtain FDA approval to address the potential underlying cause of Alzheimer’s, donanemab therapy has the potential to slow cognitive and functional decline if started in the early stages of the disease. The medication is administered every four weeks through IV infusion, each infusion lasting about 30 minutes. Patients are monitored after each infusion, usually for around 30 minutes, to see if they have any negative reactions to the drug.

Who Is Eligible For Donanemab Therapy?

Patients with symptoms of early Alzheimer’s disease and the confirmed presence of beta-amyloid plaques in the brain may be eligible for treatment with donanemab. The therapy has not been tested on people with advanced Alzheimer’s or those without clinical symptoms. Early symptoms of Alzheimer’s may include:

Mild cognitive impairment (forgetfulness and confusion)
Mild dementia (difficulty performing familiar tasks)

Although there is no single diagnostic test to confirm Alzheimer’s disease, physicians may use a variety of approaches to help them make a diagnosis and determine if treatment with donanemab might be appropriate.

Tests and procedures for diagnosing Alzheimer’s disease may include:

Comprehensive personal and family medical history
Mental status tests
Physical and neurological exams
Blood tests
Spinal tap to remove a sample of cerebrospinal fluid for testing
MRI of the brain
PET scan of the brain to look for the presence of beta-amyloid plaques

Donanemab Treatment FAQ

What Are Potential Side Effects of Donanemab?

Donanemab can have side effects, some of which are serious. Potential side effects include:

Infusion reactions such as changes in blood pressure or breathing, fever, chills, headache, rash and hives. These side effects are usually not severe and can be managed with medications such as antihistamines, anti-inflammatory medications or steroids.
Allergic reactions such as swelling of the face, lips, mouth or tongue. These reactions can be serious and may result in discontinuation of therapy.
Amyloid-related imaging abnormalities (ARIA), which may include brain bleeding, swelling or a combination of both, can be seen on a brain MRI. ARIA symptoms can include headaches, visual changes, dizziness, nausea and confusion. In rare instances, ARIA may be life-threatening. Prior to beginning donanemab therapy, patients will be tested for a specific genetic factor that may increase their risk for ARIA.

Patients approved to receive donanemab therapy will be carefully monitored at set intervals as determined by their physician. Subsequent brain MRIs, EKGs and lab tests will be obtained periodically to monitor for ARIA and other serious side effects of treatment.

Who Is Not a Candidate for Donanemab Therapy?

For some people, the risks of donanemab therapy may outweigh the benefits. Doctors will likely look for other ways to manage the disease if a patient has any of the following risk factors:

Existing brain bleeds, brain swelling or other major brain pathology.
Any serious health issue that may be affected by donanemab.
Uncontrolled bleeding disorder.
Immunological disease that requires treatment with systemic medications.
Serious hypersensitivity to donanemab.
A history of seizures.
Inability to have an MRI.
Stroke or transient ischemic attack (TIA) within the last year.

Is Donanemab Covered by Insurance?

Because donanemab is a new medication, coverage will vary among insurance providers, including Medicare and Medicaid. Patients should talk to their provider to determine coverage before beginning treatment