Alzheimer’s Disease Therapy Provides Patients With Hope

(BPT) - (In Partnership with Eli Lilly and Company)

Are you forgetting your words or losing your train of thought more than usual? Memory and thinking issues can be easily dismissed as signs of normal aging, though they could point to a more serious disease. Experts believe excessive amyloid plaque buildup may cause changes in the brain that make it difficult to do things such as retain new information, remember important dates or find the right words or names.

According to the Alzheimer's Association, 6.9 million Americans aged 65 or older are living with Alzheimer's dementia in 2024. While symptoms may be recognizable, patients may avoid reaching out to their doctors or even hide symptoms due to fear of the stigma associated with Alzheimer's disease. But Carole, 72, says that not letting herself or others dismiss her symptoms as normal aging was critical to get the diagnosis and help she needed.

"Try to stay positive," Carole advises folks who notice memory and thinking issues. "Be honest with yourself. There's help out there, but you have to sometimes seek it out yourself."

Subtle changes speak volumes

After decades of living, working, and raising kids in Kentucky, Carole and her husband Hank decided to spend their golden years in the Sunshine State. They moved to Punta Gorda, Florida, and have been enjoying retirement there for the past 11 years.

As the years passed by, Hank noticed changes in his wife. Carole began regularly repeating herself without realizing it and misplacing items around their home. Having helped care for his mother and Carole's, who both faced the challenges of Alzheimer's disease, he was familiar with some of the early signs and symptoms of the disease. Hank also knew Carole's family history with the disease meant she had an increased chance of developing it herself.

"All of a sudden, you're seeing this person is struggling to get some things done that would have just been no big deal," said Hank. "One of the key things to managing Alzheimer's disease is recognition. You just have to get in there and be supportive of your loved ones."

Self-advocacy paves a brighter future

It is estimated that about one-third of people with MCI due to Alzheimer's disease progress to a later stage within five years. Once Hank recognized the symptoms, he knew it was important to ask Carole's doctor for a cognitive screening because diagnosing Alzheimer's disease earlier has the potential to provide an opportunity for advanced care planning in collaboration with your doctor. With the availability of disease-modifying treatments and the potential to slow disease progression, an early diagnosis may allow patients to continue to do the things they enjoy for a longer time.

When Hank gently voiced his concerns about her behavior, the couple decided Carole needed to see her doctor as soon as possible. After a visit to her doctor – who said Carole's symptoms were normal for her age – Carole began doing additional research. While Carole's symptoms can be associated with normal aging, she remembered her symptoms were different than her mother's.

With Hank's support, Carole continued seeking out testing options and potential therapies. Eventually she was diagnosed with early symptomatic Alzheimer's disease and was accepted into a late-phase clinical trial for Kisunla™ (donanemab-azbt) injection for IV infusion (350 mg/20 mL). Kisunla is an amyloid-targeting therapy the FDA approved to treat early symptomatic Alzheimer's disease (mild cognitive impairment or mild dementia stage of disease) with confirmed amyloid pathology.

"I just thought, wow, I'm so lucky to get into a clinical trial," Carole said. "And it helped me. It gave me hope."

SELECT SAFETY INFORMATION

Kisunla can cause Amyloid-Related Imaging Abnormalities, or "ARIA." ARIA is a common but serious side effect that does not usually cause any symptoms, but can be serious. ARIA can be fatal. ARIA is most commonly seen as temporary swelling in an area or areas of the brain that usually goes away over time. Some people may also have spots of bleeding on the surface of or in the brain and infrequently, larger areas of bleeding in the brain can occur. Please see Indication and Safety Summary with Warnings below for additional safety information for Kisunla.

Carole's Treatment Journey

During the 18-month study, Carole and Hank say her cognitive health appeared to remain steady. Carole credits her early diagnosis of Alzheimer's disease, optimism and hope to her self-advocacy and treatment with Kisunla. In the 18-month study, Kisunla slowed the progression of memory and thinking issues that are due to early symptomatic Alzheimer's disease compared to placebo.

Kisunla is a therapy that has been shown in clinical studies to reduce amyloid plaques. Kisunla is an important advancement, since doctors can consider stopping Kisunla treatment based on the reduction of amyloid plaques to minimal levels on amyloid positron emission tomography (PET) imaging. That means some patients might not have to go in for infusions for an unlimited period of time*. [*Please note: Kisunla is administered every 4 weeks through IV infusion for 30 minutes. The long-term clinical benefit of Kisunla after stopping treatment has not been studied.]

Today, Carole spends most of her time with family. Carole and Hank have two children, one in Atlanta and one in Baltimore, and two grandchildren. When she isn't with extended family, Carole largely spends most of her time with Hank at home in Florida or traveling to her favorite destinations like the Great Smokey Mountains.

"Things might be different if I didn't first admit I had this problem or tried to get help or hadn't been in the study," she said.

Don't ignore the signs

If you or a loved one are experiencing memory or thinking issues, it's important to discuss these issues with your physician along with the potential for cognitive screening and other tests to help determine if the underlying cause of the memory and thinking issues could be due to early symptomatic Alzheimer's disease. Learn about treatment with Kisunla by visiting www.kisunla.lilly.com.

Lilly Support Services™ for Kisunla is a free support program committed to help patients navigating treatment with Kisunla. The program includes offerings such as coverage determination assistance, care coordination, nurse navigator support, and customized support and resources. For more information about Lilly Support Services and Kisunla, call 1-800-LillyRx (1-800-545-5979) or visit www.kisunla.lilly.com.

INDICATION AND SAFETY SUMMARY WITH WARNINGS

Kisunla™ (kih-SUHN-lah) is used to treat adults with early symptomatic Alzheimer's disease (AD), which includes mild cognitive impairment (MCI) or mild dementia stage of disease.

Warnings - Kisunla can cause Amyloid-Related Imaging Abnormalities or "ARIA." This is a common side effect that does not usually cause any symptoms, but serious symptoms can occur. ARIA can be fatal. ARIA is most commonly seen as temporary swelling in an area or areas of the brain that usually goes away over time. Some people may also have spots of bleeding on the surface of or in the brain and infrequently, larger areas of bleeding in the brain can occur. Although most people do not have symptoms, some people have:

• Headache
• Dizziness
• Nausea
• Difficulty walking
• Confusion
• Vision changes
• Seizures

Some people have a genetic risk factor (homozygous apolipoprotein E e4 gene carriers) that may cause an increased risk for ARIA. Talk to your healthcare provider about testing to see if you have this risk factor.

You may be at higher risk of developing bleeding in the brain if you take medicines to reduce blood clots from forming (antithrombotic medicines) while receiving Kisunla. Talk to your healthcare provider to see if you are on any medicines that increase this risk.

Your healthcare provider will do magnetic resonance imaging (MRI) brain scans before and during your treatment with Kisunla to check you for ARIA. You should carry information that you are receiving Kisunla, which can cause ARIA, and that ARIA symptoms can look like stroke symptoms. Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the symptoms listed above.

There are registries that collect information on treatments for Alzheimer's disease. Your healthcare provider can help you become enrolled in these registries.

Warnings - Kisunla can cause serious allergic and infusion-related reactions. Do not receive Kisunla if you have serious allergic reactions to donanemab-azbt or any of the ingredients in Kisunla. Symptoms may include swelling of the face, lips, mouth, or eyelids, problems breathing, hives, chills, irritation of skin, nausea, vomiting, sweating, headache, or chest pain. You will be monitored for at least 30 minutes after you receive Kisunla for any reaction. Tell your healthcare provider right away if you have these symptoms or any reaction during or after a Kisunla infusion.

Other common side effects

• Headache

Tell your healthcare provider right away if you have any side effects. These are not all of the possible side effects of Kisunla. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before you receive Kisunla, tell your healthcare provider:

• About all medicines you take, including prescription and over-the-counter medicines, as well as vitamins and herbal supplements. Especially tell your healthcare provider if you have medicines to reduce blood clots from forming (antithrombotic medicines, including aspirin).
• About all of your medical conditions including if you are pregnant, breastfeeding, or plan to become pregnant or breastfeed. Kisunla has not been studied in people who were pregnant or breastfeeding. It is not known if Kisunla could harm your unborn or breastfeeding baby.

How to receive Kisunla

Kisunla is a prescription medicine given through an intravenous (IV) infusion using a needle inserted into a vein in your arm. Kisunla is given once every 4 weeks. Each infusion will last about 30 minutes.

Learn more

For more information about Kisunla, call 1-800-LillyRx (1-800-545-5979) or go to kisunla.lilly.com.

This summary provides basic information about Kisunla. It does not include all information known about this medicine. Read the information given to you about Kisunla. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Kisunla. Your healthcare provider is the best person to help you decide if Kisunla is right for you.

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Kisunla^™ and Lilly Support Services are trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

PP-DN-US-0402 11/2024 ©Lilly USA, LLC 2024. All rights reserved.

References:

1. Porsteinsson AP, Isaacson RS, Knox S, et al. Diagnosis of early Alzheimer's disease: clinical practice in 2021. J Prev Alzheimers Dis. 2021;3(8):371-386.
2. Alzheimer's Association. 2024 Alzheimer's Disease Facts and Figures. Alzheimers Dement. 2024;20(5)
3. Wessels AM, Dennehy EB, Dowsett SA, et al. Meaningful clinical changes in Alzheimer disease measured with the iADRS and illustrated using the donanemab TRAILBLAZER-ALZ study findings. Neurol Clin Pract. 2023;13(2):e200127. doi:10.1212/CPJ.0000000000200127
4. Kisunla (donanemab-azbt). Prescribing Information. Lilly USA, LLC.
5. Kisunla (donanemab-azbt). Medication Guide. Lilly USA, LLC.

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