How to Protect Yourself From COVID-19, Flu, and RSV This Fall

Respiratory viruses, such as influenza and respiratory syncytial virus (RSV), tend to pick up during fall. On top of that, COVID-19 is still circulating, with cases increasing in recent weeks. To fight off what some are calling a “tripledemic” of all three viruses, state and federal health officials are urging people to protect themselves with vaccines.

In an interview, Bernard Camins, MD, Professor of Medicine (Infectious Diseases), and Jennifer Duchon, MD, Associate Professor of Pediatrics (Newborn Medicine), at the Icahn School of Medicine at Mount Sinai, provided additional background about vaccines that will be available this fall.

COVID-19

COVID-19 cases and hospitalizations are not as high as they used to be at the height of the pandemic. But hospitalization counts—which are still being reported—have risen in recent weeks.

“We can’t just forget about COVID-19 yet,” says Dr. Camins.

On Monday, September 11, the U.S. Food and Drug Administration (FDA) cleared updated COVID-19 vaccines for use that are formulated to more closely target currently circulating variants. The FDA approved the Pfizer and Moderna vaccines—known as “messenger RNA” or “mRNA” vaccines for the type of technology they use—for people 12 and over. It granted emergency use authorization to the same vaccines for people six months to 11 years old.

On Tuesday, September 12, a panel of the Centers for Disease Control and Prevention (CDC) voted to recommend the updated vaccines for everyone six months and older. The CDC recommended that most people get one dose of the new vaccine, at least two months after their most recent vaccine dose. People who are immunocompromised, and parents of young children, should consult their doctor for recommended dosing.

Dr. Camins said the updated COVID-19 shots from Pfizer and Moderna are monovalent vaccines—meaning they are designed to target a single variant of SARS-CoV-2, the virus that causes COVID-19—but are expected to provide broad protection against the other currently dominant circulating variants of SARS-CoV-2 as well. He said patients should check with their primary care doctor’s office or local pharmacy to find out how and when they can get the new vaccines.

“Based on past developments, it could be within a matter of days for the shots to be available to the public once the recommendation is made,” says Dr. Camins.

The number of people hospitalized due to COVID-19 has been rising steadily in the city in August. Source: NYC Department of Health and Mental Hygiene

RSV

The respiratory syncytial virus commonly causes mild, cold-like symptoms in most healthy adults and goes away after a few days. However, for infants and older adults with pre-existing heart disease or lung disease, RSV can cause severe disease. This year, new vaccines are available for these vulnerable groups.

“RSV is ubiquitous,” says Dr. Duchon. “You can try to prevent it, but even then options are limited. While parents can practice good hand hygiene and stay away from other sick people, babies often have siblings who go to school or go to daycare.”

Most of the deaths or severe disease—typically lower-respiratory-tract disease—from RSV occur in infants ages 0 to 6 months, says Dr. Duchon.

In July, the FDA approved Beyfortus™ (nirsevimab-alip), marketed by Sanofi in the United States, for use in infants entering their first RSV season and up to 24 months of age for those in vulnerable groups. In August, the FDA approved Abrysvo™, from Pfizer, as a maternal vaccine to protect infants from birth through six months of age. Beyfortus is administered directly to infants after they are born, while Abrysvo is given to mothers at 32 weeks through 36 weeks of gestation.

ACIP has recommended that Beyfortus be given to all infants younger than 8 months born during—or entering—their first RSV season, typically fall through spring. For children 8 to 19 months who are at increased risk of severe RSV disease, such as those who are immunocompromised, a second dose is recommended.

Abrysvo has yet to receive ACIP recommendation, though news reports have stated that meeting could likely occur in September.

~1-3%

of children under 12 months of age in the U.S. are hospitalized each year due to RSV

~60,000-120,000 hospitalizations and ~6,000-10,000 deaths

among adults 65 years of age and older are due to RSV

Source: CDC

It is possible that the ACIP could recommend Abrysvo on top of Beyfortus. “We are hoping that the infant vaccine will help prevent severe disease, and that the maternal vaccine will add an additional layer of protection,” says Dr. Duchon. However, she notes that given how the clinical trials were set up, the expert panel will likely examine the data closely and deliberate on the messaging.

“This could be a shared decision-making situation between a mother and her doctor,” Dr. Duchon adds.

For older adults, the FDA approved Arexvy™ as a vaccine for people ages 60 and older, in May. “Particularly for people with  heart or lung disease, RSV can exacerbate their conditions,” says Dr. Camins.

Older people in that vulnerable group should speak with their health provider on whether they should take the vaccine, especially as RSV season approaches, says Dr. Camins.

Influenza

The influenza virus season from fall 2022 to spring 2023 was marked by an early peak in November and December last year, according to the CDC. When the 2023-2024 flu season will peak is hard to pinpoint, but the CDC issued a recommendation in August for people to receive their flu shots in September or October.

“We are starting to see some influenza A cases here in our  health system, which has a connection to how influenza A and B trends might play out through fall and winter,” says Dr. Camins. It is not a prediction of an early or bad flu season by any means, but he recommends that unless contraindicated, everyone older than six months of age take the flu shot.

The annual flu vaccine has been updated with a new formula, as is common, to target strains most likely to circulate this season. Anyone six months and older is recommended to receive it, according to the CDC.

Last year, the City Department of Health and Mental Hygiene encouraged people to receive both their flu shots and COVID-19 shots together, where possible. Officials have been urging a similar message for New Yorkers to be caught up on their routine vaccinations.

“Even if you’re not at high risk for complications from the flu, getting the vaccine may prevent you from getting sick, or even if you do get sick, your symptoms will be milder if you take the shot than if you didn’t,” says Dr. Camins. “Everyone should be getting the flu vaccine.”

Tips to Ease Back-To-School Anxiety

As the back-to-school season approaches, it’s not uncommon for young children to experience butterflies in their stomachs. Back-to-school feelings of anxiety are a natural and often healthy response to change.

The team at the Mount Sinai Parenting Center at Mount Sinai Kravis Children’s Hospital has developed some simple and effective ways to help your child learn how to get through the discomfort of uncertainty. Remember your job as a parent is not to spare your child the anxiety, it is to help them prepare for, sit with, and manage their feelings of anxiety.

The Mount Sinai Parenting Center Team:

  • Blair Hammond, MD, Co-Founding Director for the Mount Sinai Parenting Center and pediatrician in the Department of Pediatrics
  • Aliza Pressman, PhD, Co-founder, Mount Sinai Parenting Center, and Assistant Clinical Professor, Pediatrics, Icahn School of Medicine at Mount Sinai
  • Mariel Benjamin, LCSW, Director of Programs, Mount Sinai Parenting Center

Here are 10 simple tips to make the process smoother for both you and your child:

  • Create a Routine: Start by establishing a consistent daily routine a few weeks before school begins. Set regular mealtimes, playtimes, and bedtimes. Predictability provides some certainty in an uncertain experience. Click here to watch a special video about sticking to consistent morning and bedtime routines.
  • Feelings: Get Hold of Our Own Feelings and All Are Welcome: Make sure you have support managing some of the anxiety that comes with watching kids try new things and feel new feelings. Model and remind your child that there are no “bad” feelings and that feelings serve to give us information. Let them know it makes sense to feel a little nervous with new experiences. Share your own stories of first-day jitters from your childhood, showing them that many people feel this way.
  • Keep Sleep Sacred: Help make sure your child is getting enough sleep. A tired brain is more vulnerable to anxiety and has fewer resources to call on the tools that will help them manage their anxiety.
  • Play “School” at Home: Incorporate pretend play to familiarize your child with the idea of school. Take turns playing the teacher and student, using stuffed animals or dolls as classmates. This playful approach can ease their fear of the unknown.
  • Explore the School Together: Arrange a visit to the school before the first day. Walk around the campus, visit classrooms, and playgrounds. Let your child ask questions and share their thoughts. Familiarity can ease their apprehensions.
  • Get Creative with Supplies: Involve your child in choosing their school supplies, backpack, and lunchbox. Letting them make decisions empowers them and creates excitement about the upcoming adventure.
  • Positive Stories and Imagery: Read age-appropriate books or tell stories about positive school experiences. Use positive imagery and stories to help your child envision a happy and exciting school day.
  • Practice Separation: If separation anxiety is a concern, practice short separations at home. Leave them with a trusted caregiver for a brief period and gradually extend the time. This can help them build confidence in being apart. Remember not to sneak out, but to explicitly state when you will be away and when you will be reunited.
  • Encourage Friendship Building: Arrange playdates with potential classmates or neighbors. Familiar faces on the first day can make a big difference in how comfortable your child feels.
  • Teach Relaxation Techniques: Simple techniques like taking deep breaths or holding a soft toy can help soothe anxious feelings. Practice these techniques together so they can use them when needed.

Back-to-school feelings of anxiety in young children is a natural part of growing up. By implementing these tips, you can help your child transition with ease and excitement.

Your support and understanding play a crucial role in making this new experience a positive one. With your guidance, your child can step into the classroom with confidence and enthusiasm.

Here’s What to Know About the First Approved Pill Treatment for Postpartum Depression

On Friday, August 4, 2023, the U.S. Food and Drug Administration (FDA) approved Zurzuvae(zuranolone), developed by pharmaceutical firms Biogen and Sage Therapeutics, to treat postpartum depression. The treatment is a pill taken once daily for 14 days, and is the first oral treatment approved for this condition.

“We’re happy there’s attention for a disease that has not gotten much attention thus far,” says Veerle Bergink, MD, PhD, Director of the Women’s Mental Health Program, and Professor of Psychiatry, and Obstetrics, Gynecology and Reproductive Science at the Icahn School of Medicine at Mount Sinai. Zurzavae had received Fast Track and Priority Review designations from the FDA, deemed as having potential to address a serious unmet need.

Veerle Bergink, MD, PhD (left) and Kimberly Mangla, MD (right)

Postpartum depression occurs often enough in mothers, yet the public’s understanding of it remains limited, says Kimberly Mangla, MD, Clinical Director of the Women’s Mental Health Program at Icahn Mount Sinai. “I’m glad we have an additional, possibly effective treatment for patients, and hopefully it will raise conversations and awareness of postpartum depression resources and treatment options,” she adds.

Drs. Bergink and Mangla explain what postpartum depression is, and how Zurzuvae could potentially treat it.

What is postpartum depression?

Postpartum depression can appear similar to other forms of clinical depression, with symptoms that include general low mood, lack of enjoyment, low energy, and low motivation, says Dr. Mangla. But there are unique aspects, such as difficulty bonding with the baby.

Postpartum depression is also different from what is commonly called “baby blues,” which is a common phenomenon of feeling overwhelmed, tearful, or being “hormonal,” notes Dr. Mangla. Baby blues tend to go away after two weeks. “What would be alarming might be feelings of hopelessness, suicidality, or a complete disconnect from the baby that aren’t necessarily a component of baby blues—those are reasons to seek support for what might be postpartum depression,” Dr. Mangla says.

While regulatory or insurance entities might define postpartum depression as occurring within four weeks after delivery, experts in the field—clinicians and researchers—agree that onset can be highly variable, even up to 12 months after delivery, says Dr. Bergink.

“From a psychological or physiological point of view, we know that it could take half a year for a woman’s hormones and immune system to go back to normal,” says Dr. Bergink. “And we have heard women say it could take up to a year before they feel like the person they were before delivery, and psychologically used to the new state of being a mother.”

What is Zurzavae, and how does it work?

Many current antidepressants work by targeting the serotonin system, but this drug works by targeting the gamma-aminobutyric acid receptor GABAA. While there are other drugs in this class of antidepressants, this is the first one approved for postpartum depression, says Dr. Bergink.

How common is postpartum depression?

One in Eight

or about 13 percent of women, have symptoms of depression after birth of baby.

>15 percent

of women in NYC experience depression symptoms after childbirth.

One in Five

women were not asked about depression during a prenatal visit.

>50 percent

of pregnant women with depression were not treated.

Source: Centers for Disease Control and Prevention

However, it is important to note that while this differs from serotonergic antidepressants, there have been no comparative studies done to demonstrate that Zurzavae is any better or worse than other antidepressant treatments out there, she points out. It is also unknown to what extent there is an antidepressant effect beyond the sedative effect, she adds.

What treatment options had been available for postpartum depression?

If the depression is not so severe, options include support therapy, such as cognitive behavioral therapy or psychotherapy, says Dr. Bergink. If it is more severe, then the doctor might consider using antidepressants, such as selective serotonin reuptake inhibitors (SSRIs).

How might Zurzavae differ from other antidepressants?

The way the drug has been marketed is that it works more rapidly than SSRIs, says Dr. Mangla. “Whether or not that’s true, and whether or not that benefit is sustained, we still have no idea,” she says, “but it would be wonderful to have a medication that starts working in three days instead of a few weeks.”

There are still some open questions clinicians might have with Zurzuvae at this point, notes Dr. Bergink. These include its effect on women who are breastfeeding, and whether the drug will keep depression away long beyond the study period, which was 45 days, she says.

What sources of support can mothers experiencing depression seek?

Generally, a mom experiencing depression symptoms should talk to anyone who is in her support system, says Dr. Mangla. This could include friends and family, but also a primary care doctor who might be able to make a referral to a general psychiatrist.

“Because the treatment of depression in postpartum is so similar to treatment of depression outside of postpartum, the disease is often well treated by general practitioners or general psychiatrists,” says Dr. Mangla.

Seeking help from social workers can be useful too. There are many ways mothers can access social workers, including through a local health institution, or even via online resources, such as Postpartum Support International, notes Dr. Mangla.

“Postpartum depression is a very treatable condition,” says Dr. Bergink. “We should do all we can to help mothers feel comfortable about reaching out for support.”

What has Zurzuvae shown in clinical trials?

Zurzuvae was approved based on data from two randomized, placebo-controlled trials in postpartum depression.

Here are the efficacy and safety highlights:

  • Both studies achieved their primary endpoint: a significant mean reduction from baseline in the Hamilton Rating Scale for Depression (HAMD-17) total score, a 17-item questionnaire on depression symptoms compared to placebo.
  • In one study, Zurzuvae achieved a significant reduction in depressive symptoms as early as day three.
  • Most common side effects of patients on Zurzuvae included drowsiness, dizziness, diarrhea, fatigue, and urinary tract infection.
  • The FDA has included a warning on Zurzuvae’s label that instructs health care providers to advise patients that the drug causes driving impairment due to sedative effects, and patients should not engage in activities that require mental alertness until at least 12 hours after the 14-day treatment.

 

Living with Alopecia Areata: Five Coping Strategies to Help With the Emotional Toll

Benjamin Ungar, MD, Director of the Alopecia Center of Excellence at Mount Sinai, examines a patient.

Being diagnosed with alopecia areata, an autoimmune condition that affects millions of people in the United States, brings more than the physical challenges of hair loss. Your emotional state can be greatly influenced by the disease progression.

“The emotional toll of alopecia areata can be devastating, but there are strategies that can help you remain positive, manage your symptoms, and thrive,” says Emma Guttman, MD, PhD, a highly renowned expert in alopecia and other inflammatory skin diseases, and the Waldman Professor of Dermatology and Clinical Immunology, and System Chair of the Kimberly and Eric J. Waldman Department of Dermatology, at the Icahn School of Medicine at Mount Sinai.

For those who may be facing these challenges, Benjamin Ungar, MD, Director of the Alopecia Center of Excellence at Mount Sinai, offers five strategies for coping.

 

Learn about new treatments

Most importantly, keep hope alive by learning about new treatments in the pipeline for alopecia areata. Ask your dermatologist about newly approved and potential future treatments or get involved in clinical trials. Mount Sinai has two clinical trials enrolling adults and several more starting later in 2023 for adults and children with alopecia areata: one with Dupixent (dupilumab), a drug administered by injection, and Sotyktu (deucravacitinib), a pill. Contact your dermatologist or email our Clinical Research Program Director, Giselle Singer at giselle.singer@mssm.edu to see if you qualify for either trial.

 

Reduce and manage stress

Stress is a part of everyday life, and it can affect the cycles of hair loss and regrowth. Many people find that stress can contribute to worsening alopecia. Making healthy living habits a priority can help to relieve stress. Manage your stress with daily exercise, yoga, or daily meditative practice. Get at least seven to eight hours of sleep a night. Turn off notifications on your phone and other electronic devices when you are not working to help you disconnect and recharge. Learn to say no to unnecessary commitments and to create boundaries giving you the space for relaxation and self-care.

 

Be creative with accessories to build confidence

Stylish hats, scarves, or good quality wigs can express your creativity and boost your confidence as well as protect bare skin from the elements. Dealing with hair loss does not preclude looking and feeling your best.

 

Find support.

You are not alone. There are many support groups that can help you connect with other people who are dealing with the same challenges you are facing. These groups can help you manage your feelings, provide a supportive network, and build your self-esteem to help you cope with the challenges ahead.

 

Seek help

Seek help from a professional counselor or therapist. If you are struggling, consider reaching out to a professional who can help treat anxiety or depression by working with you to develop coping strategies specific to your experience.

How to Keep Your Kids Safe This Summer and All Year Round: Tips From the ER

Summer is a time for kids to have fun, enjoy vacations, and especially their favorite outdoor activities. It’s also a time for parents to take notice, as many outdoor injuries and health hazards are preventable.

Chris Strother, MD, and Lauren Zinns, MD, emergency medicine specialists at The Mount Sinai Hospital and associate professors in emergency medicine and pediatrics at the Icahn School of Medicine at Mount Sinai, share five key takeaways to help parents, caregivers, and families recognize and avoid common injuries and health hazards.

Young children are at a high risk of choking

  • Common things they choke on are hot dogs, grapes, and small round toys. Ensure that food is cut into small pieces and that young children are supervised when they are eating.
  • If your child is unable to cough or breathe while choking, call 911 first, then try these maneuvers:
    • For children younger than one year old: Place the infant face down on your arm resting on your thigh. With the palm of your other hand, give the baby five short, yet forceful, blows between the shoulder blades. If that is unsuccessful, place the infant on the back, put two of your fingers in the center of the chest below the nipples and press five times.  Continue five back blows and five chest thrusts until the foreign body is removed. Never place your finger inside the infant’s mouth as that could push the foreign body in further.
    • For children older than one year of age: Stand behind the child with your arms around the child’s waist. Make a fist and place it below the chest just above the navel.  Grab the fist with your other hand and push upward repeatedly until the food particle or toy is removed.

Click here for more information about how to help someone who is choking and for helpful illustrations.

Bug bites and insect stings can cause mild to severe allergic reactions in kids

  • Experts recommend bug spray on all exposed areas of skin, especially in the evenings when flying bugs are out the most, or in wooded areas where ticks are more likely to be found.
  • If your child has a tick, try to remove it as soon as possible.
  • Call your pediatrician if you notice a target-like lesion, as this could represent early signs of Lyme disease.
  • Mosquito bites will often cause a local allergic reaction at the site, this is usually not dangerous. If the area becomes very large, is very painful, or if your child develops a fever, the site might be infected. Call your pediatrician or go to the Pediatric Emergency Department.

Practice safety in the water

The American Academy of Pediatrics (AAP) reports that drowning is the single leading cause of death among children ages 1 to 4. Adult supervision is critical at all times.

  • Always swim with others.
  • Learn to swim at a young age and practice.
  • Wear a life jacket.
  • Be aware of weather conditions.
  • Make sure there is a lifeguard. If you aren’t watching the water, make sure someone else is watching for you, particularly with young children.
  • Here are more tips from the AAP.

Riding bikes and scooting can be great exercise

  • Wear a helmet when riding a bike or scooting. Accidents can happen fast.
  • Keep your bike “tuned up.” Make sure brakes work well and tires are inflated and in good condition.
  • Always obey traffic laws; ride with traffic if riding in the street.
  • Wear bright colors when in the street so cars can see you.

Heat awareness: Make sure to hydrate

  • Hydrate before and after you are in the heat. People don’t often think to drink before they go out, but it makes a huge difference to prevent dehydration.
  • Look for shade if possible, and take frequent breaks from activity to rest.
  • Sunblock is essential. Ensure that children are covered with sunscreen 30 SPF or greater to prevent burns, pain, and skin cancer later in life. Reapply frequently after swimming.

What Is Leqembi (lecanemab), and Will It Revolutionize Alzheimer’s Disease Treatment?

On July 6, the U.S Food and Drug Administration (FDA) granted traditional approval to Leqembi® (lecanemab), a drug developed by pharmaceutical firms Eisai and Biogen to treat Alzheimer’s disease. This decision converts the accelerated approval Leqembi received in January, following a confirmatory trial that demonstrated verified clinical benefit.

“Up until now, no one considered this a treatable disease,” says Mary Sano, PhD, Professor of Psychiatry and Director of the Alzheimer’s Disease Research Center at the Icahn School of Medicine at Mount Sinai. The full approval of lecanemab marks an exciting chapter for treating Alzheimer’s disease, providing physicians with more options. Cognitive specialists at Mount Sinai are now offering lecanemab as a treatment.

Mary Sano, PhD, Director of the Alzheimer’s Disease Research Center at the Icahn School of Medicine at Mount Sinai

What is lecanemab and how does it tackle Alzheimer’s disease? How might a patient access it at Mount Sinai? Dr. Sano explains why this drug will make a big impact in treating this condition, which is all too common among the aging.

What is lecanemab?

Lecanemab is a monoclonal antibody treatment that’s designed to reduce amyloid beta plaques in the brain. It is delivered as an intravenous infusion, over approximately one hour, once every two weeks.

“It is widely accepted that amyloid beta is a defining agent for Alzheimer’s disease,” says Dr. Sano. While the causes of Alzheimer’s disease are not fully known, accumulations of amyloid beta and other proteins such as tau tangles have been observed in patients, and are hypothesized to cause memory and functional loss.

The drug has been approved for mild cognitive impairment (MCI) and mild dementia. Patients in this category are still able to perform daily tasks, such as driving or going to work, but might experience memory lapses, such as forgetting words or location of objects.

What does this drug mean for patients?

In the confirmatory clinical trial that helped lecanemab clinch its full approval, the drug showed a statistically significant reduction in cognitive decline compared to placebo.

What patients can expect is a slowing of cognitive and functional loss, says Dr. Sano. The outcomes measured in the study relate to instrumental activities that early-stage Alzheimer’s disease patients might struggle with—paying bills, banking, certain computer tasks.

“The demonstrated effect is modest, but it’s robust, seen across all measures,” she notes. Those benefits were seen at month three of treatment and persisted through month 18, at the end of the study.

“I don’t want to overstate that this is the be-all and end-all of treatment,” Dr. Sano adds. “I’m not telling you this is a huge effect and the person goes back to 100 percent normal. But until the lecanemab studies, we had other monoclonal antibodies and we’ve not seen such consistent benefits.”

How can I access lecanemab?

The Centers for Medicare and Medicaid Services (CMS) announced in early July that lecanemab is eligible for Part B coverage under Medicare. One of the requirements is documented evidence of amyloid beta plaque in the brain, which requires imaging.

“If you don’t have the presence of amyloid, this means this is a drug you cannot use, even if you are symptomatic with memory or other cognitive problems,” Dr. Sano says.

Side effects for lecanemab could include amyloid-related imaging abnormalities (ARIA), and take the form of either bleeding or swelling in the brain, or both. Some genetic factors, such as the apolipoprotein E (APOE) ε4 gene, may increase the risk of ARIA. Other factors, such as whether patients are on blood-thinning medications, should also be considered before accessing treatment. At Mount Sinai, each patient who is interested in lecanemab receives a personalized evaluation to determine eligibility and appropriate counseling.

There could be economic barriers to access, Dr. Sano notes. Lecanemab has been reported to cost $26,500 per year. Under traditional Medicare, patients could expect to pay a 20 percent copay for treatment, although that might be covered by a supplemental insurance plan. Eisai has also launched a patient assistance plan.

In addition to the drug, there are other associated costs, including positron emission tomography (PET) for amyloid imaging, infusion, and travel expenses. Coverage of those expenses depends on the insurance.

“We need to make sure underrepresented groups can access this treatment,” says Dr. Sano.

Will lecanemab change how we look at Alzheimer’s disease?

Prior to lecanemab, the prevailing view of patients diagnosed with MCI or mild dementia had been a wait-and-see approach, Dr. Sano says. Practitioners might be resistant to start an early-stage patient on active treatment, and similarly, patients who are highly functional might be reluctant to compromise their autonomy.

“There’s a barrier to changing our culture, but it’s clearly surmountable,” notes Dr. Sano. “The one difference we have to consider is this: people don’t stay in mild dementia forever. We need to change the culture to get this addressed early.”

What has lecanemab shown in clinical trials?

In a placebo-controlled, double-blind randomized study of 1,795 people, lecanemab showed a statistically significant and clinically meaningful reduction in decline of the Clinical Dementia Rating (CDR), a cognitive and functional measure based on patient and caretaker reports and the trial’s primary outcome. Key secondary outcomes included measurements of change in amyloid beta and other cognitive scales and measurements of daily living capabilities.

Here are the efficacy and safety highlights:

  • Lecanemab-treated patients demonstrated a 27 percent slowing of decline in CDR compared to those on placebo at 18 months.
  • Statistical significance for CDR was seen starting as early as six months, with the difference from placebo widening every three months.
  • On a 100-point Centiloids scale, with 0 being a patient with no amyloid beta and 100 being the average amount of plaque a mild-to-moderate Alzheimer’s disease patient might have, the lecanemab group saw reduced plaque burden of 55.5 at 18 months, whereas the placebo group saw an increase of 3.6.
  • Statistical significance for amyloid burden was achieved starting at three months.
  • The most common side effects in the lecanemab group were infusion effects, with 26.4 percent having experienced it. Of those, 96 percent were considered mild to moderate.
  • Other side effects include amyloid-related imaging abnormalities—which could occur from amyloid-targeting therapies—as well as headaches and falls. Serious adverse events were reported in 14 percent of the lecanemab group and 11.3 percent of the placebo group.