Early Alzheimer’s Disease

Alzheimer’s Disease Treatment Offers Hope to Patients in the Early Stages of Disease

The Importance of Early Diagnosis and Treatment

The earlier Mild Cognitive Impairment (MCI) due to Alzheimer’s Disease (AD) and mild AD dementia are diagnosed and treated, the greater the opportunity for benefit [1].

Sponsored by and provided by Eisai and Biogen

Introduction

Last July, the U.S. Food and Drug Administration (FDA) issued a notable approval for LEQEMBI® (lecanemab-irmb), the first medicine to slow the rate of cognitive decline in certain patients with early Alzheimer’s disease (AD), a brain disorder that gets worse over time and affects memory, language, and thinking [1,2].

The Clinical Study

The treatment was tested in a large 18-month clinical study in patients with mild cognitive impairment (MCI) and mild dementia due to early AD. Even though you cannot stop AD from getting worse, with LEQEMBI, you can take steps to slow how fast it progresses [3]. That’s why identifying symptoms early on is so important [1].

Targeting the Underlying Cause

“In recent years, there have been significant treatment advancements for people living with Alzheimer’s disease,” said Diana Kerwin, MD, a geriatric care physician and founder of Kerwin Medical Center in Dallas. “LEQEMBI targets and removes plaques that build-up in the brain—an underlying cause of the devastating disease [4,5,6,7]. The symptoms of early AD are often confused with normal aging, and many people don’t speak up until symptoms have worsened [1]. By speaking to your doctor as soon as you see symptoms, you have a greater opportunity to manage and treat the disease [1].”

Potential Side Effects

LEQEMBI can cause serious side effects including amyloid-related abnormalities (ARIA), serious allergic reactions, and infusion-related reactions. Some people may have small spots of bleeding in or on the surface of the brain, sometimes fatal events with larger areas of bleeding have occurred. Ask your doctor about testing for a genetic risk factor that may cause an increased risk for ARIA. Tell your doctor the medicines you take, including if you take medications to reduce blood clots from forming such as antithrombotic medicines like aspirin. Some medicines can increase the risk for larger areas of bleeding in the brain. Most common side effects included infusion-related reactions, swelling in areas of the brain, and headache. These are not all the possible side effects of LEQEMBI [3].

Recognizing the Symptoms

KNOW THE SYMPTOMS

Early AD, when symptoms first start, is often known as mild cognitive impairment (MCI) due to AD or mild dementia [1]. MCI has tell-tale symptoms that can include repeating questions or forgetting appointments. With mild dementia, symptoms may be even more noticeable and include worsening memory and other cognitive function that impairs independent day-to-day activities, such as handling finances and paying bills [1]. One in three people with MCI due to AD will develop dementia due to AD within five years [1].

It can be difficult to distinguish early AD from the normal signs of aging and because this disease gets worse over time, getting an accurate diagnosis from a physician and discussing treatment options early on is important [1].

“Typically, with normal aging, people may struggle to remember names or come up with words for certain things, like forgetting where they placed their keys and then remembering a few minutes later,” Kerwin said. “With early AD, people may start to repeat questions. They might ask ‘What are we eating for dinner?’ You tell them, and then 15 minutes later, they ask again. Another sign is when people misplace items to the point where they can’t find them, or forget events, more than just once or twice. What’s more is they might have difficulty with judgment and problem-solving. When identifying a diagnosis, I’ll assess if symptoms have changed from the past, are consistent and are getting worse [1].”

Consulting with a Doctor

HOW YOUR DOCTOR CAN HELP

A doctor can assess a person’s cognitive function to determine an AD diagnosis. A cognitive exam may be performed to test memory, thinking, problem-solving, and other mental functions. Laboratory tests can rule out other conditions that cause symptoms similar to AD. A neurological exam can test reflexes, speech, and how your body is functioning [8].

Your doctor will also need to check for the presence of amyloid plaques in the brain to confirm an AD diagnosis and determine which treatment is right for you. An amyloid positron emission tomography (PET) scan uses a special machine that takes pictures of your brain to check for amyloid plaque in the brain [1]. Another testing option is a cerebrospinal fluid (CSF) test that takes samples of the fluid around your brain and spinal cord. Both tests check for amyloid proteins that build up into amyloid brain plaque and can give your doctor specific insights into plaque buildup [1].

“This treatment option has really shifted the Alzheimer’s disease landscape for patients who are diagnosed early. That’s why it’s so important not to wait if you’re seeing changes,” Kerwin said. “We know a family history of AD is a major risk factor [1]. Nearly two in three people diagnosed are women, and Black and Hispanic people are at higher risk [1]. Speaking with your primary care doctor is an important first step [1]. They may refer you to a neurologist who can help confirm your diagnosis and help decide if LEQEMBI could be a treatment option for you.”

If you or someone you love is experiencing memory loss or problems with thinking, especially if you are noticing a regular pattern, it’s important to talk to your doctor about your concerns. Learn more about LEQEMBI, a treatment option for mild cognitive impairment or mild dementia due to AD, at LEQEMBI.com.

What is LEQEMBI?

LEQEMBI is a prescription medicine used to treat people with Alzheimer’s disease.

If you have serious allergic reactions to any of the ingredients in LEQEMBI, you should not be treated with LEQEMBI.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about LEQEMBI?

LEQEMBI can cause serious side effects including:

• ARIA (amyloid-related imaging abnormalities). There are usually no signs of ARIA. In rare cases, it can lead to serious complications
• ARIA can show up as swelling in parts of the brain or small spots of bleeding
• Larger areas of bleeding in the brain may occur, but this is uncommon
• ARIA usually goes away over time
• Most people with ARIA don’t have any symptoms. However, some people may notice:

• headache
• confusion that gets worse
• dizziness
• vision problems
• nausea
• problems walking
• seizures

Some people have a gene called ApoE4 that may increase the risk of ARIA. Talk to your healthcare provider about testing to see if you have this gene

Some medicines can increase the risk of larger areas of bleeding in the brain for people taking LEQEMBI. Talk to your healthcare provider to see if any of the medicines you’re taking increase this risk

Your healthcare provider will check for ARIA with MRI (magnetic resonance imaging) scans before you start LEQEMBI and during treatment

Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the symptoms listed above.

Before receiving LEQEMBI, tell your healthcare provider about all your medical conditions, including if you:

• are pregnant or plan to become pregnant. It is not known if LEQEMBI will harm your unborn baby. Tell your healthcare provider if you become pregnant during your treatment with LEQEMBI
• are breastfeeding or plan to breastfeed. It is not known if any of the ingredients in LEQEMBI pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while receiving LEQEMBI

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your healthcare provider if you take medicines to reduce blood clots from forming (including aspirin). Ask your healthcare provider for a list of these medicines if you are not sure.

Keep a list of the medicines you take. Show it to your healthcare provider and pharmacist when you get a new medicine.

What are the possible side effects of LEQEMBI?

LEQEMBI can cause serious side effects, including:

•   ARIA (amyloid-related imaging abnormalities) (see above)

•   Serious allergic reactions may happen during a LEQEMBI infusion. Tell your healthcare provider if you notice any of these symptoms during or after a LEQEMBI infusion:

• swelling of the face, lips, mouth, or tongue
• itchy bumps on the skin, also known as hives
• difficulty breathing  

•   Infusion-related reactions are common and can sometimes be serious. Tell your healthcare provider right away if you notice any of these symptoms during an infusion:

• fever
• flu-like symptoms (chills, joint and body aches, feeling shaky)
• nausea and/or vomiting
• dizziness or lightheadedness
• fast or slow heart rate, or feeling like your chest is pounding
• difficulty breathing or shortness of breath  

Your healthcare provider may give you medicines before your next infusion to lower the chance of having a reaction. 

The most common side effects of LEQEMBI include:

• infusion-related reactions
• swelling in areas of the brain, with or without small spots of bleeding in or on the surface of the brain (ARIA)
• headache

These are not all the possible side effects of LEQEMBI. Call your doctor for more information and medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please read the accompanying full Prescribing Information including Boxed WARNING, and Medication Guide for LEQEMBI.

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[1] 2023 Alzheimer’s Disease Facts and Figures. Alzheimer’s Association. 2023. Accessed February 13, 2024. https://www.alz.org/media/Documents/alzheimers-facts-and-figures.pdf [2] FDA Converts Novel Alzheimer’s Disease Treatment to Traditional Approval. U.S. Food and Drug Administration. July 6, 2023. Accessed February 13, 2024. https://www.fda.gov/news-events/press-announcements/fda-converts-novel-alzheimers-disease-treatment-traditional-approval [3] LEQEMBI US Prescribing Information Under Traditional Approval. [4] Brendza RP, Bacskai BJ, Cirrito JR, et al. Anti-aβ antibody treatment promotes the rapid recovery of amyloid-associated neuritic dystrophy in pdapp transgenic mice. The Journal of Clinical Investigation. February 1, 2005. Accessed February 13, 2024. https://doi.org/10.1172/JCI23269.   [5] Ono K, Tsuji M. Protofibrils of amyloid-β are important targets of a disease-modifying approach for alzheimer’s disease. International Journal of Molecular Sciences. 2020;21(3). https://doi:10.3390/ijms2103095. [6] Söderberg L, Johannesson M, Nygren P, et al. Lecanemab, aducanumab, and gantenerumab — binding profiles to different forms of amyloid-beta might explain efficacy and side effects in clinical trials for alzheimer’s disease. Neurotherapeutics. 2023;20(1). https://doi:10.1007/s13311-022-01308-6. [7] Hartley DM, Walsh DM, Ye CP, et al. Protofibrillar intermediates of amyloid β-protein induce acute electrophysiological changes and progressive neurotoxicity in cortical neurons. The Journal of Neuroscience. 1999;19(20). https://doi:10.1523/jneurosci.19-20-08876.1999.   [8] 2022 Medical Tests for Diagnosing Alzheimer’s. Alzheimer’s Association. 2022. Accessed February 13, 2024.  https://www.alz.org/alzheimers-dementia/diagnosis/medical_tests.

SDGs, Targets, and Indicators

1. Which SDGs are addressed or connected to the issues highlighted in the article?

• SDG 3: Good Health and Well-being

The article discusses the approval of a medicine for the treatment of early Alzheimer’s disease, which is a brain disorder that affects memory, language, and thinking. This is connected to SDG 3, which aims to ensure healthy lives and promote well-being for all at all ages.

2. What specific targets under those SDGs can be identified based on the article’s content?

• Target 3.4: By 2030, reduce by one-third premature mortality from non-communicable diseases through prevention and treatment and promote mental health and well-being.

The article highlights the approval of a medicine that can slow the rate of cognitive decline in patients with early Alzheimer’s disease. This aligns with Target 3.4, which focuses on reducing premature mortality from non-communicable diseases and promoting mental health and well-being.

3. Are there any indicators mentioned or implied in the article that can be used to measure progress towards the identified targets?

• Indicator 3.4.1: Mortality rate attributed to cardiovascular disease, cancer, diabetes, or chronic respiratory disease.
• Indicator 3.4.2: Suicide mortality rate.

The article does not explicitly mention any indicators. However, the progress towards Target 3.4 can be measured using indicators such as the mortality rate attributed to non-communicable diseases (e.g., Alzheimer’s disease) and the suicide mortality rate, as mental health and well-being are also important aspects of the target.

Table: SDGs, Targets, and Indicators

SDGs	Targets	Indicators
SDG 3: Good Health and Well-being	Target 3.4: By 2030, reduce by one-third premature mortality from non-communicable diseases through prevention and treatment and promote mental health and well-being.	Indicator 3.4.1: Mortality rate attributed to cardiovascular disease, cancer, diabetes, or chronic respiratory disease. Indicator 3.4.2: Suicide mortality rate.

Source: cbsnews.com