June 7, 2021: A Historic Day


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On June 7, 2021, the FDA approved Biogen drug aducanumab, the first-ever disease-modifying therapy for early stage Alzheimer’s disease. Through the years, we have never let go of hope, but this feels like a true turning point. As pointed out in the UsAgainstAlzheimer’s (UsA2) press release below, with the approval of this first drug, the second, third, fourth, and beyond, should follow at a more rapid pace.

UsAgainstAlzheimer’s AlzTalks – June 9

To hear the latest, be sure to register for UsA2’s June 9th (4pm ET) AlzTalks. Click HERE to register.

Meryl Comer will moderate a discussion that will include one of Biogen’s top leaders as well as George Vradenburg, Chairman & Co-Founder of UsAgainstAlzheimer’s, Russ Paulsen, Chief Operating Officer of UsA2, and advocates Jim and Geri Taylor. Geri lives with Alzheimer’s disease and participated in the Clinical Trial for this therapy.

UsAgainstAlzheimer’s Press Release

Washington, D.C. (June 7, 2021) – UsAgainstAlzheimer’s issued the following statement from George Vradenburg, chairman and co-founder, on the Food and Drug Administration’s decision to approve Biogen’s aducanumab, the first disease-modifying therapy for early-stage Alzheimer’s. 

“This first disease-slowing drug is a dramatic turning point in the fight against Alzheimer’s. Hope will replace despair for many families in the early stages of the disease. 

“By delaying the progression for people in the early stages of the disease, this drug therapy promises to give people more time to live independently and perform daily activities longer.  

“We believe that FDA’s approval of aducanumab will have a positive ripple effect on pharmaceutical innovation far beyond this one drug. To get to the best-in-class drug – and ultimately a cure – there must be a first-in-class drug such as aducanumab. This approval will spark additional investment by other companies in disease-modifying treatments and therapies. With approval of this first drug, drugs 2, 3, 4 will follow, and at a faster pace.  

“We are very concerned about the ability of patients to gain access to aducanumab, particularly those on Medicare fee-for-service without supplemental insurance. And, shockingly, Medicare does not reimburse patients for the expensive PET scans important to determine whether someone is appropriate for this drug. We intend to work with Biogen and Medicare to make access to this drug affordable for every American who needs it.

“After so many disappointments in potential treatments, the Alzheimer’s community now knows this deadly enemy has finally been engaged. At long last, science and time are on our side. Patients in the early stages of the disease will engage with their physicians to learn what can be done, with early detection, to slow their cognitive decline and this disease. 

“Because aducanumab is for people in the early stages of the disease, it will be important for people to learn whether it is right for them. Our new BrainGuide™ platform empowers people with the knowledge and confidence to take the best next steps in managing their own or a loved one’s brain health. BrainGuide is free and easy to access at mybrainguide.org or at 855-BRAIN-411.”

Source: https://www.usagainstalzheimers.org/press/usagainstalzheimers-hails-fda-approval-aducanumab-first-disease-modifying-therapy-early-stage

Lisa Genova’s Comments on the Approval of Aducanumab

Lisa Genova is a Neuroscientist, a #1 international & NY Times Bestselling Author, and a TED speaker. Her comments below can be found on Instagram. Be sure to follow Lisa at https://www.instagram.com/authorlisagenova/.

“Today, the FDA approved Aducanumab, the very FIRST disease-modifying treatment for Alzheimer’s disease.

“Aducanumab is a monoclonal antibody that clears a protein called beta-amyloid from the brain. If you’ve watched my TED talk, you’ll remember that uncleared amyloid can stick to itself, forming amyloid plaques. If the accumulation of amyloid plaques reaches a tipping point, this will trigger a molecular cascade that results in neuron death and a kind of dementia we call Alzheimer’s.

“Think of amyloid plaques below the tipping point as a lit match. After the tipping point, the brain is set on fire.

“This drug blows out the match.

“Aducanumab is currently approved for people with early-stage Alzheimer’s (lit match, brain not yet on fire) who have had a positive PET scan confirming the presence of beta-amyloid in their brains. Dosing will be by infusion, once a month. Not ideal, but a very exciting and hopeful beginning.

“This historic approval will also likely accelerate the development, approval, and reimbursement of biomarkers and simple blood tests for Alzheimer’s. In the near future, we won’t need to rely on PET scans or lumbar punctures to identify the early signs of Alzheimer’s—tests that the vast majority of folks will never have because they’re too expensive, too invasive, and not accessible.

“Much like getting your cholesterol levels checked for heart disease, we’ll soon have a blood test that measures your brain’s relative risk of becoming ablaze with Alzheimer’s. And then, again much like we do for heart disease, we’ll come up with a plan to lower that risk—through diet, exercise, managing stress, getting enough sleep, staying socially and cognitively active, and now, possibly adding a drug that clears beta-amyloid (like statins do with cholesterol).

“Today marks an exciting, massively important step in the battle against Alzheimer’s.“

Source: Lisa Genova via Instagram

Approval of Aducanumab Highlights the Need for Health Equity

While we celebrate the FDA’s approval of the first disease-modifying therapy for early-stage Alzheimer’s, we must not lose sight of the work required to ensure aducanumab and future drugs are available to ALL who need them. Without proper focus on this critical issue, current disparities in health care are only likely to widen as new treatments emerge.

In order for aducanumab to work, early diagnosis is critical. In fact, drugs like this are most successful when started before patients begin showing signs of dementia. Key diagnostics include brain imaging (PET scan) and spinal taps, both requiring high-cost specialty care that is out of the reach of many minority patients; further, Medicare does not reimburse for PET imaging.

Black people are twice as likely and Hispanic people are 1.5 times more likely than white people to have Alzheimer’s or other dementias. The wealth gap is evident in many areas and certainly, health care is one of the most significant. We must make sure the cost of diagnostics and therapies are within reach of every single American who needs them.

To learn more about how health care inequity affects many Black and Latinx families, please read this article about Sonia Cardona and her primary caregiver, daughter Daisy Duarte. Ms. Cardona developed young-onset Alzheimer’s in her 50’s and was misdiagnosed for at least five years despite a very obvious family history.

Source: https://www.statnews.com/2021/06/04/aducanumab-alzheimers-drug-approval-would-likely-deepen-racial-inequities-in-dementia-care/

UsAgainstAlzheimer’s National Alzheimer’s Summit: Don’t Miss It!


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Due to COVID-19, this year’s UsAgainstAlzheimer’s National Summit is a FREE virtual experience jam packed with outstanding speakers and topics!

The event will be held Oct 19-21, and you can attend all sessions, or choose the ones that interest you the most. Registration is still open; just visit http://www.usa2summit.org to register – you don’t want to miss this fantastic conference!

Marilyn’s Legacy is honored to be an ambassador for the 2020 Summit.

10/25/20 UPDATE: All sessions are now available to view on demand at https://www.usa2summit.org/.

Happy 84th Birthday, Mom.


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On October 12, 2020, my mom would have celebrated her 84th birthday. When I see healthy, vibrant seniors around that age, I can’t help but imagine what Mom would have been like if Alzheimer’s hadn’t gotten in the way.

In the eight years since her death, we’ve come a long way in terms of shining the light on this disease and bringing it out of the shadows. While a certain level of stigma still exists, people are talking much more openly about their personal experiences, many families are asking for help, and progress is being made in terms of the general public understanding the importance of early diagnosis.

Although we don’t always hear about it, encouraging work is being done in research labs across America and the world. I recently attended a Cure Alzheimer’s Zoom call and heard leading researcher Dr. Rudy Tanzi discuss many studies currently underway. That call served as a reminder that forward progress is being made each and every day. Hope is alive.

Back in 2016, I founded Marilyn’s Legacy because I wanted to keep my mom’s memory alive, and I needed a way to give purpose to everything we had been through. I needed to know something positive resulted from the suffering Mom endured. Because of our many generous supporters, in five years of existence, over $19,000 in donations have been directed to UsAgainstAlzheimer’s, the Cure Alzheimer’s Fund, The Ohio State University Alzheimer’s Fund in Neurology, the HFC (formerly Hilarity for Charity) Caregiver Respite Grant Program, and the National Church Residences Hospice Caregiver Support Program (earmarked for dementia families). I’m very proud of what we’ve accomplished, but there is always more to do.

Families of the over 5 million Americans current living with Alzheimer’s and other forms of dementia are facing challenges the likes of which many cannot fathom.  No two days are the same and it is an experience that defies all logic.

Losing a lifetime of memories would certainly be horrendous on its own, but that merely scratches the surface when it comes to these diseases. Severe agitation, paranoia, verbally and physically abusive behaviors, delusions, hallucinations, loss of ability to speak, inability to manage the activities of daily living,  and eventually inability to swallow – as time goes on, these symptoms and others can become commonplace.

As we mark Mom’s 84th birthday, we hope you might consider making a one-time or recurring tax-deductible contribution to this, our 5th annual giving campaign. To do so, please visit  http://marilynslegacy.org/donate

Other ways to help:

Amazon Smile. When shopping Amazon, please use our Amazon Smile link:  http://smile.amazon.com/ch/81-1813012.  By your taking this simple action, Amazon will make a donation to Marilyn’s Legacy and it won’t cost you a dime! Bookmark our link and use it each time you shop!

Alzheimer’s Semipostal Stamp.  Thanks to the tireless efforts of advocates Kathy Siggins and Lynda Everman, the Alzheimer’s stamp has returned. Before being withdrawn in 2017, the stamp had generated over $1.0 million for NIH supported research. Stamps are available for purchase at most post offices, online at https://store.usps.com/store/product/buy-stamps/alzheimers-S_564204 and by phone at 1-800-STAMP-24. Get yours today! For additional information, please check out this fantastic blog post by Carlen Maddux.

Share this post. A quick share of this post to your social media channels is a great way to help spread the word!

Thank you for taking the time to visit The Long and Winding Road. We’re grateful for your support! May you and yours remain safe and healthy during the coming weeks and months.