Alzheimer’s disease medicines typically help reduce and manage symptoms. They do not treat the cause of Alzheimer’s disease. Kisunla offers a new approach to treat early Alzheimer’s disease. It targets the root cause of Alzheimer’s to help slow how quickly symptoms worsen.
How Does Kisunla Work for Alzheimer’s Disease?
Alzheimer’s disease is a brain disorder that develops slowly over time. You may know it as a condition that causes memory loss in older adults. With Alzheimer’s disease, parts of the brain responsible for memory, understanding, language, attention, reasoning, and judgment become damaged. In Alzheimer’s, brain cells build up a toxic substance called amyloid.
You may hear that Alzheimer’s disease is a type of dementia. Dementia is a general term that refers to problems with thinking clearly that make it harder to live daily life. Alzheimer’s disease mainly affects older adults but can also occur in people under 65 years old.
Doctors divide Alzheimer’s into stages based on how severe the symptoms are. The stages are presymptomatic (no symptoms yet), mild cognitive impairment, and dementia. The dementia stage is further divided into mild, moderate, and severe stages.
Your symptoms depend on the stage of the disease. Early on, short-term memory loss is usually the first symptom. As Alzheimer’s disease gets worse, it may cause problems with daily tasks like meal preparation, navigation, and money management. In the later stages, people may have symptoms that affect the mind. Some psychological effects of later stages of Alzheimer’s include a lack of caring or interest, withdrawal from social interactions, or agitation and seeing things that are not real.
There is no cure for Alzheimer’s disease, but treatments can help manage symptoms. Kisunla is a newer treatment that works to slow down how fast Alzheimer’s progresses. It contains an antibody called donanemab-azbt, which targets and clears amyloid from the brain. By doing this, Kisunla may help slow down the damage Alzheimer's disease causes to the brain.
Beta-amyloid is a naturally occurring protein that is linked to Alzheimer’s disease. People with Alzheimer’s have high levels of beta-amyloid, and it clumps between brain cells. When it clumps together, it becomes hard for brain cells to work properly and talk to each other.
At first, the parts of the brain involved in memory are damaged. Later, other areas of the brain involved in thinking, reasoning, and remembering are affected. In advanced stages of Alzheimer's, the person becomes unable to communicate and requires care from others.
How Do I Use Kisunla?
Kisunla is given through an intravenous (IV) infusion, which is an injection into your bloodstream that takes about 30 minutes. You will receive Kisunla at a hospital or clinic, and a health care provider will give you the IV.
You will start with 700 milligrams (mg) every four weeks for three doses. After that, your health care provider will increase your dose to 1,400 mg every four weeks. Before you receive Kisunla, your health care provider will order a special brain scan called tau positron emission tomography (PET). The tau PET scan checks for buildups of amyloid in your brain.
Your health care provider may stop treatment with Kisunla if you have a drop in amyloid buildup to very low levels.
What Are Other Unique Considerations to Be Aware Of?
Before you start and during your treatment, your health care provider will order magnetic resonance imaging (MRI) tests to check for a serious side effect of Kisunla called ARIA. ARIA stands for amyloid-related imaging abnormalities. This happens when medicines like Kisunla cause unusual changes in brain MRI images. ARIA does not always cause symptoms. In rare situations, people may develop side effects like:
- Headache
- Confusion
- Vomiting
- Vision changes
- Balance problems
Sometimes, symptoms of ARIA may be serious. ARIA usually goes away within four months after a reduction in your dose or after you stop the medicine.
Some symptoms of ARIA are similar to those of a stroke. To help your health care provider know if your symptoms are from Kisunla or a stroke, they need to know all the medicines you take. Always carry a list of your medicines.
Some people may be at higher risk of ARIA and serious problems such as swelling of the brain (edema) or bleeding in or around the brain. About 15% of people with Alzheimer’s disease have two copies of a gene called apolipoprotein E ε4 (ApoE ε4), which increases their risk of ARIA and severe effects. Before you start Kisunla, your health care provider will order a genetic test to check your risk of getting ARIA.
How Was Kisunla Studied for Alzheimer’s Disease?
A clinical study was done to see whether Kisunla is effective for treating Alzheimer’s disease. Everyone in the study was diagnosed with early-stage Alzheimer’s, which includes mild cognitive symptoms or mild dementia. Brain scans showed a buildup of a substance called amyloid, which is linked to the development of Alzheimer’s disease. The study enrolled patients from many countries, including the U.S.
Researchers randomly grouped the people in the study into two groups. One group received Kisunla, and the other received a placebo (a dummy medicine that has no effect). The people studied switched to the placebo group if their brain scans showed improvement after week 24, 52, or 76 of the study. The study lasted for 72 weeks, and the people in it were monitored until week 76.
People in the study ranged from 59 to 86 years of age; 68% had low/medium tau level and 32% had high tau level; and 71% were ApoE ε4 carriers and 29% were ApoE ε4 noncarriers. Fifty-seven percent of the people in the study were female, 91% were White, 6% were Asian, 4% were Hispanic or Latino, and 2% were Black or African American.
To check if Kisunla was effective for Alzheimer’s disease, researchers compared the people’s scores on the integrated Alzheimer’s Disease Rating Scale (iADRS) before treatment and after 76 weeks. This score tracks Alzheimer’s disease progression and shows whether a treatment works better than a placebo. The iADRS combines two tests: one that measures memory and thinking skills called the ADAS-Cog (Alzheimer Disease Assessment Scale-13-item Cognitive subscale), and another that assesses daily tasks like meal preparation and personal hygiene, called the ADCS-iADL (Alzheimer Disease Cooperative Study-Instrumental Activities of Daily Living subscale).
Another score used in the study to measure Kisunla’s effectiveness was the Clinical Dementia Rating (CDR) scale. Health care providers use the CDR scale to see how much help someone with Alzheimer’s disease needs for daily activities like personal care, meal preparation, or money management.
What were the benefits?
Slower disease progression: After 76 weeks, some people who received Kisunla showed improvements in the four clinical assessment tools:
- Integrated Alzheimer’s Disease Rating Scale (iADRS)
- Alzheimer Disease Cooperative Study-Instrumental Activities of Daily Living subscale (ADCS-iADL)
- Clinical Dementia Rating (CDR)
- Alzheimer Disease Assessment Scale-13-item Cognitive subscale (ADAS-Cog)
These improvements mean Kisunla slowed down the progression of Alzheimer’s disease. In the clinical study, compared with a placebo, Kisunla slowed Alzheimer’s disease worsening by more than 20% on the iADRS and CDR scores. For about 47% of people who received Kisunla in the clinical study, the disease did not get worse at all. In comparison, only 29% of those who received the placebo had similar results.
Reduction in amyloid plaques: Some people who received Kisunla also had less amyloid buildup on brain scans at the end of the study. In the clinical study, about 76% of people had low levels of amyloid buildup at week 76. In comparison, only 0.3% of those who received the placebo had similar results.
How Long Does It Take for It to Work?
Kisunla starts to target amyloid in your brain after you receive your first dose. But it may take several months before you, your caregivers, and your health care provider notice your symptoms of Alzheimer’s disease have slowed down.
To see how well Kisunla is working for you, your health care provider will order tests to check how much amyloid you have on your brain scans. Your health care provider may also ask you or your caregivers questions about your daily life and symptoms while you are taking Kisunla.
How Can I Prevent and Manage Side Effects?
The most common side effects are changes in your brain scans, which experts call ARIA. ARIA stands for amyloid-related imaging abnormalities. You might not have symptoms of ARIA, and the only sign may be changes in how your brain looks on a magnetic resonance imaging (MRI) scan. In rare situations, ARIA can be linked to serious issues, including swelling (edema) of the brain or bleeding in or around the brain.
If your brain MRI shows signs of ARIA, your health care provider may adjust or stop your treatment with Kisunla. Your health care providers’ decision to continue or stop treatment depends on how severe the brain scan changes are and how severe your symptoms are, if you have any.
Another common side effect of Kisunla is a headache. In rare situations, a headache may be a symptom of ARIA. If you get a headache after receiving Kisunla, tell your health care provider right away.
These are not all the possible side effects of Kisunla. Talk with your health care provider if you are having symptoms that bother you. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What Kinds of Drug Interactions Can Happen?
Since Kisunla may cause ARIA with brain swelling or bleeding in or around the brain, researchers studied the effects of combining it with different blood thinners throughout the clinical trial.
There is no clear evidence that Kisunla and blood thinners increase the risk of ARIA with brain swelling (edema) or bleeding in the brain. The risk appears similar to Kisunla alone. But it is still important for your health care provider to evaluate the risks.
If you are already using Kisunla and need a blood thinner, your health care provider will carefully review your options. ARIA can sometimes cause symptoms similar to a stroke. Your health care provider will need to check if ARIA or something else caused your symptoms before you start blood clot medication.
If you have a higher risk of bleeding in the brain, your health care provider will also weigh the benefits and risks of Kisunla treatment for you.
This is not a complete list of interactions. Tell your health care provider about all the prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, or other supplements you take or have recently taken.
