Tag Archives for Maria C. Carrillo

A close look on “Facts and Figures” about Alzheimer’s

Published in RINewsToday on April 3, 2023

For over five years, Janet Bryant, 65, has been a caregiver for her 67-year-old husband, Paul, who suffers from Alzheimer’s disease. Their daughter, Alison, and husband Ryan, living in the condo above her parents, step in to assist with caregiver duties when needed. 

“It’s often a long day when you’re caring for someone with dementia,” says Janet, who handles all financial, medical and household tasks. Even when Paul helps out with a few tasks he must be closely supervised, she says. And you must be watchful. “A few weeks ago, Paul was trying to make a cup of tea, and put the metal tea kettle in the microwave, causing the handle to burst into flames. I disabled the microwave and now I make him his tea. His wife of 47 years says he can’t be left alone, and gets lost in their small condo. 

Janet acknowledges that the long day often continues into night, as Paul has trouble finding the bathroom or tries to roam around. 

Janet’s experiences as a caregiver taking care of a loved one with Alzheimer’s disease is not uncommon. The newly released Alzheimer’s Disease Facts and Figures reports that 6.7 million people aged 65 and over, like Paul, are living with Alzheimer’s or other dementias in the United States — it’s one of the costliest conditions to society and is projected to reach $345 billion, a $24 billion increase from a year ago. By 2050 these costs could rise to nearly $1 trillion.

In 2022, like Janet, more than 11 million caregivers provided unpaid care for people with Alzheimer’s or other dementias, providing an estimated 18 billion hours of unpaid assistance — a contribution valued at $339.5 billion, noted Facts and Figures.

Taking a look at Facts and Figures

The Alzheimer’s Association’s 2023 Facts and Figures report (the first released in 2007) provides an in-depth look at the latest national and state-by-state statistics on Alzheimer’s disease prevalence, mortality, caregiving, dementia care workforce and costs of care. 

Alzheimer’s disease is not a normal part of aging; it’s a devastating cognitive disorder that will be the number 1 killer by 2050. This year’s Fact and Figures findings indicate that 1 in 3 seniors dies with Alzheimer’s or another dementia. This devastating disorder also kills more than breast cancer and prostate cancer, combined. Between 2000 and 2019, deaths from heart disease have decreased by 7.3% while deaths from Alzheimer’s disease have increased by 145%.  

Researchers found that while only 4 in 10 Americans talk to their physician right away when experiencing early memory or cognitive loss, 7 in 10 would want to know if they have Alzheimer’s disease if it could allow for earlier medical treatment. 

This year’s report also examines the capacity of the medical specialty workforce essential for diagnosis, treatment and ongoing care for people living with Alzheimer’s and all other types of dementia. The shortage of dementia care specialists could soon become a crisis for Alzheimer’s disease care, warn the researchers, especially with the recent FDA accelerated approval of new treatments targeting the underlying biology of Alzheimer’s disease, which is reframing the health care landscape for people with early-stage Alzheimer’s or MCI due to Alzheimer’s disease.

Caring for those living with Alzheimer’s or other dementias poses special challenges, the report noted. As dementia symptoms worsen, caregivers can experience increased emotional stress (59%), depression, anxiety, chronic stress, and new or exacerbated health problems. Additionally, caregivers often experience depleted income and finances due to disruptions in employment, and paying for health care or other services for both themselves and those with dementia.

While recent advancements in treatment of early-stage Alzheimer’s, including mild cognitive impairment (MCI) due to Alzheimer’s disease, are providing hope to millions living with memory loss and early cognitive decline, the latest Fact and Figures finds too often individuals with memory concerns, and their doctors, are not discussing the issue, missing a critical first step toward diagnosis and potential treatment.

“Providing the best possible care for Alzheimer’s disease requires conversations about memory at the earliest point of concern and a knowledgeable, accessible care team that includes physician specialists to diagnose, monitor disease progression, and treat when appropriate,” said Maria C. Carrillo, Ph.D., chief science officer of the Alzheimer’s Association, in a statement announcing the release of the 128-page report.

“For the first time in nearly two decades, there is a class of treatments emerging to treat early-stage Alzheimer’s disease. It’s more important than ever for individuals to act quickly if they have memory concerns or experience symptoms.”

An accompanying special report, The Patient Journey in an Era of New Treatments, offers new insights from patients and primary care physicians (PCPs) on current barriers that impede earlier discussion of cognitive concerns. Focus groups reveal many people with subjective cognitive decline (self-reported memory concerns) do not discuss cognitive symptoms with their health care providers. Previous special reports have indicated many people believe their experiences are related to normal aging, rather than a potential diagnosable medical condition.

Taking a close look at Rhode Island

The number of people aged 65 and over with Alzheimer’s and other dementia continues to increase in Rhode Island, from 24,000 in 2020, and expected to climb to 27,000 by 2025.  That’s an estimated 12.5% increase.  Fifty-two percent of Rhode Island caregivers report having one chronic condition, 41% say they are depressed and 11% rate their health as poor. 

Currently there are 36,000 unpaid caregivers in the Ocean State providing about 51 million total hours of uncompensated care (valued at over $1.29 million).  

The cost of health care continues to skyrocket to care for those with Alzheimer’s and other dementias.  The state’s Medicaid program spends over $470 million, with the projected cost to increase by 20.1% by 2025. 

Two years ago, there were 33 practicing Geriatricians in Rhode Island. By 2050, a 48.5% increase of this medical specialty will be needed to meet the patient care demands. Three years ago, there were 7,410 Health and Personal Care Aides providing care. By 2030, an increase of direct care workers by 27.5% will be needed to provide personal care. 

Implications for Rhode Island lawmakers, state officials

Donna McGowan Executive Director of the RI Chapter of the Alzheimer’s Association expects the release of the latest Alzheimer’s Disease Facts and Figures to educate state policy makers about the impact of Alzheimer’s on their own communities and districts, specifically the number of Rhode Islanders living with Alzheimer’s or related dementia, and the number of caregivers who provide for them. 

“Further, along with personal discussions, the report will help them to understand the reality that many of their constituents are hesitant to seek a medical diagnosis, or even support it. And the report will highlight for policy makers the crisis that is the shortage of workers in the Alzheimer’s and related dementia professional caregiving field,” notes McGowan.

As the 2023 Alzheimer’s Disease Facts and Figures indicates, a growing number of caregivers have approached the Rhode Island chapter to access programs and services, says McGowan. Last fiscal year, approximately 4,600 individuals contacted the Rhode Island chapter to access programs and services which equated to an “8% overall increase over the previous fiscal year,” she said.  

According to McGowan, this year they are tracking approximately a 16% increase in individuals contacting their helpline, totaling approximately 5,336 individuals accessing programs and services. 

“With the report showing we may not have sufficient specialist capacity to deal with the projected increase in Rhode Islanders with ADRD, there is a critical need to provide Rhode Island primary care practices with the training needed to care for persons with dementia and their caregivers,” says Maureen Maigret, Policy Advisor for Senior Agenda Coalition of RI (SACRI), who also serves on the state’s Advisory Council on Alzheimer’s Disease and Care and a member of The Care Transformation Collaborative (CTC).  Fortunately, the CTC, in partnership with the Rhode Island Department of Health, is offering such training now through the state’s Geriatric Education Center. 

“And with a projected need for close to a 30% increase in home health aides and personal care attendants, the workforce shortage will worsen dramatically if we fail to increase direct care staff wages and expand training staff to care for persons with ADRD,” warns Maigret, noting that this is why SACRI is advocating for funding to increase direct care staff wages to a minimum of $20 an hour. 

“As the prevalence of people living with dementia continues to increase in Rhode Island, the health system and long-term care continuum will be challenged by the findings highlighted in this report,” says Nancy Sutton, MS, RD, the Rhode Island Health Department’s (RIDOH) Chief, Center for Chronic Care and Disease Management. “RIDOH, the Rhode Island Alzheimer’s Disease and Related Disorders Advisory Council, and our many partners are committed to continuing efforts to educate the public on the importance of speaking to a healthcare provider about memory concerns, she said.

Sutton says, “with the support of federal funding, resources such as a Brain Health Toolkit are being developed to support health system partners in their engagement in conversation with patients and caregivers about the importance of early detection and navigating complex systems of care and community resources to support people living with dementia.”

“We know that age is a big risk factor for Alzheimer’s Disease and Related types of Dementia (ADRD),” said the RI Office of Healthy Aging (OHA) Director Maria Cimini. “As Rhode Islanders age if they or their caregivers are concerned about memory loss, we encourage them to talk to their physicians and get connected to resources through the Point, 401-462-4444 or through myoptionsri.gov to help navigate this journey.” 

At OHA, we have worked to build comfort and capacity among physicians through a recent Alzheimer’s Disease Programs Initiative (ADPI) grant with the focus of expanding the Dementia-Capable Home and Community Based Services which include outreach and education of primary care/direct service providers in identification, diagnosis, referral, and care planning process for ADRD and to provide services supportive of individuals living with dementia and their family caregivers within the statewide Aging and Disability Resource Center. OHA and its partners developed a provider resource tool to assist providers with referring patients with cognitive symptoms and family caregivers to services; and it also provides guidance to providers in conducting care planning, and billing for dementia-related services. That resource can be found here: https://oha.ri.gov/resources/oha-resource-center.

For a copy of the 2023 Alzheimer’s Disease Fact and Figures, go to: https://www.alz.org/alzheimers-dementia/facts-figures.

For a copy of the accompanying special report, The Patient Journey in an Era of New Treatments, to https://www.alz.org/media/Documents/alzheimers-facts-and-figures-special-report.pdf.

The Alzheimer’s Association’s  24/7 Helpline clinicians guide callers to financial assistance programs that may help pay for respite or a needed break. Caregivers will also find programs and services offered by this organization, too. For details, go to https://www.alz.org/ri.

Controversial move by CMS limits coverage for new Alzheimer’s drug, Aduhelm 

Published in RINewsToday on April 25, 2022

Earlier this month, amid the pleas of the Alzheimer’s Association, the National Committee to Protect Social Security and Medicare, and other aging advocacy groups, the Centers for Medicare & Medicaid Services (CMS) made its final decision to limit their Medicare coverage of the controversial Alzheimer’s drug, ADUHELM® , for only those Medicare recipients participating in clinical studies overseen by the National Institutes of Health (NIH) or in other approved clinical trials.

When releasing its decision on April 7, CMS noted from the onset, the federal agency “ran a transparent, evidence-based process that incorporated more than 10,000 stakeholder comments and more than 250 peer-reviewed documents into the determination” to make its decision.

Calls for More Rigorous Studies

According to CMS, over 6 million older Americans are believed to have Alzheimer’s, and this prevalence is expected to rise to 14 million by 2060, barring effective interventions. CMS stated that effective treatments are needed, and because of the early, but promising, evidence and the immense burden of this devastating disease on the Medicare population, the agency is finalizing Medicare coverage, calling for rigorous studies approved by the U.S. Federal Drug Administration (FDA) and NIH to help answer whether this class of drugs improves health outcomes for patients.

“Science, evidence, and stakeholder input led our team of career civil servants and clinicians through this national coverage determination process. There is potential for promise with this treatment; however, there is not currently enough evidence of demonstrating improving health outcomes to say that it is reasonable and necessary for people with Medicare, which is key consideration for CMS when making national coverage determination, said Dr. Lee Fleisher, CMS Chief Medical Officer and Director of the Center for Clinical Standards and Quality, in a statement announcing CMS’s regulatory payment decision.

“In arriving at this final decision, we looked at the unique circumstances around this class of treatments and made a decision that weighed the potential for patient benefit against the significance of serious unknown factors that could lead to harm,” added Fleisher. “If a drug in this class shows evidence of clinical benefit through the traditional FDA approval process, then CMS will provide broad access and ensure the results from the rigorous trials are generalizable for people with Medicare participating in a CMS-approved study, such as a registry,” she said, noting that this decision was made to provide CMS flexibility to respond quickly to providing coverage for any new drugs in this class showing a clinical benefit. 

Biogen, a biotechnology company that manufacturers ADUHELM®m , was quick to give its opinion about CMS’s final decision about coverage of this drug. The Cambridge, Massachusetts based company charged that “this unprecedented decision effectively denies all Medicare beneficiaries access to ADUHELM®m , the first and only FDA approved therapy in a new class of Alzheimer’s drugs. It may also limit coverage for any future approved treatment in the class. These coverage restrictions, including the distinction between accelerated approval and traditional approval, have never been applied to FDA-approved medicines for other disease areas.”

When additional data from this new class of treatments become available, Biogen urged CMS to reconsider its final decision for all FDA-approved amyloid-beta targeting therapies. The company says that it is carefully considering its options and will provide updates as the company further evaluates the business impact of this decision.

Creating Unnecessary Barriers to Care 

Calling the CMS decision wrong, the Chicago-based Alzheimer’s Association expressed deep disappointment, charging that it has essentially ignored the needs of people living with Alzheimer’s disease. “CMS has created unnecessary barriers for individuals with Alzheimer’s disease. Patients with Alzheimer’s, a fatal disease, should have FDA approved treatments covered by Medicare just as those facing other diseases do,” said Harry Johns, Alzheimer’s Association chief executive officer. 

Notably, CMS has said in its decision the only way for patients to access the first approved FDA treatment targeting amyloid in those living with Alzheimer’s is to enroll in a clinical trial. While we note CMS has expanded where those clinical trials may take place, in reality this remains an unnecessary and never before imposed barrier to access an FDA-approved treatment, says Johns.

“People living with MCI, Alzheimer’s disease and other dementia deserve the same access to therapies given to those living with other conditions like cancer, heart disease and HIV/AIDS. They deserve the opportunity to assess if an FDA-approved treatment is right for them,” said Joanne Pike, Dr.P.H., Alzheimer’s Association president. “Drugs that treat people in the early stages of Alzheimer’s could mean more time for individuals to actively participate in daily life, have sustained independence and hold on to memories longer,” she said.

According to the Alzheimer’s Association, CMS has incorporated one of its recommendations into the final rule. “Importantly, CMS has decided to utilize a registry for future treatments granted full FDA approval. The Alzheimer’s Association registry will play an important role in collecting and analyzing real-world data. This registry will monitor and report clinical and safety endpoints for patients treated with FDA-approved AD therapies, including accompanying diagnostics, to track the long-term outcomes associated with these therapies in real-world settings. Similar successful registries in heart disease and cancer have enabled researchers, clinicians, health systems and payers to track the long-term performance of therapies using a large, real-world evidence dataset,” the advocacy group says. 

The Alzheimer’s Association also expressed strong concern about the immediate impact CMS’s decision will have on Alzheimer’s and dementia research and innovation. “The agency’s decision to essentially reject the Accelerated Approval Pathway for monoclonal antibodies targeting amyloid for the treatment of Alzheimer’s disease is broad overreach. Accelerated approval is a pathway created by Congress and utilized by FDA to allow for earlier approval of drugs that treat serious conditions, and that fill an unmet medical need. Alzheimer’s is a deadly disease with no survivors,” stated the advocacy group.

“The decision by CMS is a step backward for families facing Alzheimer’s disease,” said Maria C. Carrillo, Ph.D., Alzheimer’s Association chief science officer. “Years of increased research funding has led to more progress and innovation than ever before, but today’s decision may halt this progress as developers question if there is a pathway forward to coverage,” she said.

Calls for Reducing Cost of Medicare Part B Premiums

Max Richtman, President and CEO of the National Committee to Preserve Social Security and Medicare, calls on CMS to “swiftly reduce the hefty 2022 Medicare Part B premium increase ($21.60 per month), now that the agency has made its final decision to limit coverage of the controversial Alzheimer’s drug, ADUHELM®m, to patients in clinical trials.” 

“The spike in Medicare Part B premiums was partly based on the drug’s exorbitant cost (originally priced at $56,000 per year) and the potential expense of wider coverage,” says Richtman, noting that the agency is still “reviewing” Part B premiums, under previous direction from HHS Secretary Xavier Becerra. “Medicare beneficiaries struggling to pay their bills need relief from this year’s premium increase as soon as possible, warns Richtman. .

“The Aduhelm controversy highlights the urgent need for Medicare to be able to negotiate drug prices with Big Pharma. If the price of Aduhelm had been negotiated, it is unlikely that it would have impacted Medicare premiums so dramatically in the first place,”  adds Richtman, 

For a fact sheet on Medicare coverage policy for monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease, visit https://www.cms.gov/newsroom/fact-sheets/medicare-coverage-policy-monoclonal-antibodies-directed-against-amyloid-treatment-alzheimers-disease.

To read the final NCD CED decision memorandum, visit https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=305.

AAIC 2019 Concludes, Researchers Share Findings to Combat Alzheimer’s disease

Published in the Woonsocket Call on July 20, 2019

Thousands of the world’s leading professionals, involved in dementia care and neuroscience research, came at the Los Angeles Convention Center from July 13 to July 18, 2019, to attend the Alzheimer’s Association International Conference® to learn about the findings of the latest Alzheimer’s disease clinical trial and a government-driven public/private initiative to speed them up.

AAIC® is considered to be the largest and most influential international meeting with a mission to advancing dementia research. Every year, AAIC® brings together the world’s leading basic science and clinical researchers, next-generation investigators, clinicians and the care research community, to share research findings that’ll lead to methods of preventing, treating, and improving the diagnosis of Alzheimer’s disease.

“It is clear, and has been for some years that the (Alzheimer’s) field needs to explore other options, and diversify the portfolio of targets. A renewed energy has been brought about by a fivefold increase in Alzheimer’s research funding at the federal level. These gains will propel already-established efforts by the National Institute on Aging, Alzheimer’s Association and others to diversify (therapeutic) targets,” said Maria C. Carrillo, Ph.D., Alzheimer’s Association chief science officer, in a July 17 statement publicizing research findings from the international conference.

Hundreds of Findings of Clinical Trials Shared

According to the Chicago-based Alzheimer’s Association, “a record number of scientific abstracts – more than 3,400 – were submitted to AAIC this year, including 229 abstracts with results from or descriptions of Alzheimer’s clinical trials. AAIC 2019 also spotlighted three clinical trials using innovative methods and targets.”

At AAIC 2019, attendees were updated about the activities of the Accelerating Medicine Partnership-Alzheimer’s Disease (AMP-AD), a partnership among government, industry, and nonprofit organizations (including the Alzheimer’s Association) that focuses on discovering, validating and accelerating new drug targets. The Alzheimer’s Association says that this $225 million research initiative is made possible through the highest-ever levels of U.S. federal funding for research on Alzheimer’s and other dementias, approved and allocated in the last five years.

“This is an example of how the government and private entities and researchers can work together [via AMP-AD funded studies] on providing the resources necessary to expand our abilities to test new drugs and find a treatment for Alzheimer’s disease, and, hopefully find a cure,” said Donna M. McGowan, Executive Director of the Alzheimer’s Association, Rhode Island Chapter. “Rhode Island has tremendous researchers, and they are at the forefront of this initiative. they need the tools to increase their scope of work.”

Adds Maria C. Carrillo, Ph.D., Alzheimer’s Association chief science officer, “It is clear, and has been for some years that the field needs to explore other options, other avenues, and diversify the portfolio of targets. A renewed energy has been brought about by a fivefold increase in Alzheimer’s research funding at the federal level, achieved largely due to efforts by the Alzheimer’s Association, the Alzheimer’s Impact Movement, and our ferocious advocates. These gains will propel already-established efforts by the National Institute on Aging, Alzheimer’s Association and others to diversify the portfolio of drug targets for the scientific community.”

The achievements of the AMP-AD Target Discovery Project were highlighted in a series of presentations by the leading AMP-AD investigators at AAIC 2019.

One study noted for the first time, 18-month results from an open-label extension of inhaled insulin in Mild Cognitive Impairment and Alzheimer’s including significant benefits for memory ad thinking, day to day functioning, and biological markers of Alzheimer’s.

Another described a newly-initiated 48-week Phase 2/3 clinical trial of a drug targeting toxic proteins released in the brain by the bacterium, P. gingivalis, generally associated with degenerative gum disease. Previous research findings identified the bacterium in brains of more than 90 percent of people with Alzheimer’s across multiple studies and demonstrated that infection may trigger Alzheimer’s pathology in the brain.

Can lifestyle Interventions Promote Brain Health?

There was also an update on the Alzheimer’s Association U.S. Study to Protect Brain health Through Lifestyle Intervention to Reduce Risk (U.S. POINTER) study, now up and running in multiple locations. The U.S. POINTER is a two-year clinical trial to evaluate whether intensive lifestyle interventions that target many risk factors for cognitive decline and dementia can protect cognitive function in older adults at increased risk for cognitive impairment and dementia. Researchers will compare the effects of two lifestyle interventions on brain health in older adults at risk for memory loss in the future. The U.S. POINTER is the first such study to be conducted in a large group of Americans across the United States.

The researchers say people age 60 to 79 will be randomly assigned to one of two lifestyle interventions. Both groups will be encouraged to include more physical and cognitive activity and a healthier diet into their lives and will receive regular monitoring of blood pressure and other health measurements. Participants in one intervention group will design a lifestyle program that best fits their own needs and schedules. Participants in the other intervention group will follow a specific program that includes weekly healthy lifestyle activities.

Laura Baker, Ph.D., associate professor of gerontology and geriatric medicine at Wake Forest School of Medicine, and one of the principal investigators of the U.S. POINTER study, said, “Lifestyle interventions focused on combining healthy diet, physical activity and social and intellectual challenges represent a promising therapeutic strategy to protect brain health.”

“U.S. POINTER provides an unprecedented opportunity to test whether intensive lifestyle modification can protect cognitive function in older Americans who are at increased risk of cognitive decline and dementia,” Baker added.

“We envision a future where we can treat and even prevent Alzheimer’s through a combination of brain-healthy lifestyle and targeted medicines, as we do now with heart disease,” Carrillo said. “We hope to prevent millions from dying with Alzheimer’s and reduce the terrible impact this disease has on families.”

For more details about research findings presented at AAIC 2019, http://www.alz.org/aaic