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

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Senators Seek to Identify Subpar Nursing Homes

Last month, U.S. Senators Bob Casey (D-PA) and Pat Toomey (R-PA) succeeded in prodding the Centers for Medicare and Medicaid Services (CMS) to publicly release the April listing of underperforming nursing homes across the nation that require closer regulatory scrutiny but are not receiving any. Before CMS released the listing of candidates to the Special Focus Facility (SFF) program, the federal agency, charged with overseeing the care and quality in nursing homes, had not publicly identified these troubled facilities.

Less than 6 percent (88 facilities) out of more than 15,700 nursing homes nationwide are participants of the SFF program. CMS publicly identifies these facilities to the public. But an additional 2.5 percent (or approximately 400 facilities) qualify as candidates for the program because of having a “persistent record of poor care” but are not selected because of limited resources at CMS, according to a 26-page report, “Families’ and Resident’s Right to Know: Uncovering poor care in America’s Nursing Homes,” released in June 2019 by Pennsylvania’s two U. S. senators.

Nursing homes that are part of the SFF program have 12 to 18 months to correct any deficiencies and have two clean CMS surveys. If a facility fails to meet that target, it is are subject to increased regulatory enforcement, including being dropped from the Medicare and Medicaid programs.

Calls for Transparency

On March 4, 2019, Casey and Toomey wrote to CMS requesting information on its oversight of nursing homes in the SFF program. In that letter, the Senators requested the federal agency to provide the names of the 400 SFF candidates, calling for details about programs operations, scope and overall effectiveness. On May 3, 2019, CMS provided a written response and two weeks later, on May 14, the Senators received the listing of SFF candidates for April 2019. The names of these SFF candidates were not made public until Cassy and Toomey forced the issue by releasing this information in their report on June 5.

In CMS administrator Seema Verna’s May 14 letter to the two senators, Rhode Island-based participants and candidates in the SFF program were identified. They are: Charlesgate Nursing Center (SFF Candidate); Hebert Nursing Home (SFF Candidate); Oak Hill & Rehabilitation Center (SFF); St. Elizabeth Manor East Bay (SFF Candidate); and Tockwotton on the Waterfront (SFF Candidate).

In responding to the senators, Verma said that regardless of whether a nursing home is part of the SFF program, “any facility that performs poorly on surveys and continues to jeopardize residents’ health and safety will be subject to CMS enforcement,” which includes civil money penalties, denial of payment for new admissions or termination from the Medicare and Medicaid programs. Verma also stressed that in addition to her agency’s regulatory oversight, its Nursing Home Compare website has been improved to include “new, more reliable sources for obtaining staffing and resident census data, as well as including more claims-based quality measures.”

“Regardless of participation in the SFF program, any facility that performs poorly on surveys and continues to jeopardize residents’ health and safety will be subject to CMS enforcement remedies, such as civil money penalties, denial of payment f-or new admissions, or termination,” adds Verma.

Casey and Toomey believe that the list of SFF candidates is information that must be publicly available to individuals and families seeking nursing care for their loved ones. For that reason, the Senators have released the April 2019 list of SFF candidates and are continuing to work with CMS to make future lists public.

Through the release of the SFF candidate list and the Senate report, which details preliminary findings from surveys and public information about these candidate facilities, the Senators aim to provide Americans and their families with the transparency and information needed to choose a nursing home that would provide quality care to a loved one.

CMS Inquiry Identifies Issues

Casey and Toomey’s CMS inquiry into the SFF program put the spotlight on several issues. It became apparent to the two senators that a nursing home’s participation in the SFF program was not easily understandable to the public or would-be residents and their families. It became clear that CMS’s Nursing Home Compare, the agency’s online website, was not consistently updated to reflect any changes in the SFF program. “For example, in March 2019, the small icon used to indicate that a facility is an SFF participant was not on the webpage of five of the 17 newly-added SFF participants,” noted the Senate report. Most important, CMS’ website did not identify SFF candidates.

According to the released Senate report, only CMS and the state regulatory agency in which the nursing home is located and the facility itself, had knowledge of who is an SFF candidate. While CMS requires every nursing home to notify residents and its community of its regulatory SFF participant designation, these requirements do not apply to SFF candidates.

Aside from CMS recently updating its Nursing Home Compare webpage to more clearly indicate which nursing homes are SFF participants, it lacks details about the SFF program. There is no information explaining the reason for a facility’s participation in the program, the length of time it has been in the program or whether it has fixed the care issue. Most important, CMS does not include information on facilities that routinely cycle in and out of the SFF program, says the Senate report.

“There are few decisions more serious or life-altering than that of choosing a nursing home. I am pleased that CMS has taken the work that I have done with Senator Toomey seriously and is heeding our call to release the list of nursing facilities that are nominated to the Special Focus Facility program,” said Casey. “Our bipartisan work will ensure that families have all the information at their fingertips when choosing a nursing home. Now we must work in a bipartisan fashion to ensure the SFF program is working properly and that CMS has the funding it needs to improve underperforming nursing homes nationwide,” he says.

Adds, Toomey, “Ensuring that families have all the information they need about a nursing home will improve the quality of care at facilities across the country.”

Bills Passed to Assist Rhode Island’s Seniors, Disabled

Printed in the Woonsocket Call on July 7, 2019

With the dust settling after the adjournment of the Rhode Island General Assembly’s 2019 legislative session on June 30, 2019, Rhode Island Governor Gina Raimondo halfheartedly signed the state’s 2020 fiscal year $9.9 billion budget into law.

The newly enacted budget closes a $100 million budget gap while avoiding new taxes for businesses, fully funding the state’s education aid formula, continuing to phase-out the car-tax, maintaining fiscal support for municipalities. And, State lawmakers did not forget older Rhode Islanders and disabled persons, putting tax dollars into programs assisting them.

Included in the state budget signed by Raimondo is $499,397 to fund the Rhode Island Livable Home Modification Grant Act that was introduced by Rep. Joseph M. McNamara, D-Warwick, Cranston and Sen. Walter S. Felag Jr., D -Bristol, Tiverton, Warren.

The grant allows eligible homeowners and renters to retrofit their residence to nationally recognized accessibility standards and receive 50 percent of the total sum spent, up to $5,000, to retrofit their existing residence.

The intent of this state program is to assist older Rhode Islanders and disabled persons to stay safely in their homes longer rather than being admitted to costly nursing homes, which costs taxpayers millions of dollars each year in Medicaid costs. With the graying of state’s population, there is a need for housing that is safe and adapted to the needs of their older occupants. (The Livable Home Modification Grant Application and Post-Retrofit Claim form can be found at http://www.gcd.ri.gov.)

Meanwhile, aging advocates gave the thumbs-up to Rhode Island lawmakers who eliminated a sunset provision in the state budget for a program that provides fare-free bus passes to low-income seniors and elderly Rhode Islanders, making this program permanent.

Awaiting the Governor’s Signature

The General Assembly passed legislation (S 0691A, H 6219), introduced by Senator Frank S. Lombardi, D-Cranston and Rep. Evan P. Shanley, D-Warwick, that would help caregivers to build onto their houses to provide space for relatives. The measure now moves to the governor’s office for consideration.

The passed legislation expands the definition of “family member” for purposes of zoning ordinances to include child, parent, spouse, mother-in-law, father-in-law, grandparents, grandchildren, domestic partner, sibling, care recipient or member of the household.

Under the legislation, the appearance of the home would remain that of a single-family residence with an internal means of egress between the home and the accessory family dwelling unit. If possible, no additional exterior entrances would be added. Where additional entrance is required, placement would generally be in the rear or side of the structure.

This legislative session, State lawmakers also approved legislation sponsored by Sen. Adam J. Satchell D- West Warwick and Rep. Robert E. Craven, D- North Kingstown, to establish a formal process recognizing “supported decision making,” a structure of support for disabled or aging individuals.

The legislation, which now heads to the governor’s desk, establishes a system of personal support that is less restrictive than guardianship to help individuals maintain independence while receiving assistance in making and communicating important life decisions. It is aimed at providing an alternative with more self-determination for individuals who are aging or who have developmental or intellectual disabilities.

Under the bill (2019-S 0031A, 2019- H5909), Rhode Islanders would be able to designate another person, or a team of people, as a supporter who would help them gather and weigh information, options, responsibilities and consequences of their life decisions about their personal affairs, support services, medical or psychological treatment, education and more. The supporter would also help the individual communicate the person’s wishes to those who need to know.

The legislation creates a legal form that establishes the agreement between individuals and their supporters, and designates the types of decisions with which the supporter is authorized to help. The bill establishes that decisions made with support under such an agreement are legally valid, and allows supporters to assist with the accessing of an individual’s confidential health and educational records.

It also requires that any other person who is aware that an individual is being abused, neglected or exploited by their supporter is obligated to report that abuse to the proper authorities.

Protecting Rhode Island’s Seniors and Disabled from Financial Exploitation

Sen. Valarie J. Lawson, D-East Providence and Rep. Joe Serodio’s D-East Providence, legislation (2019-0433A, 2019-H 6091A), “Senior Savings Protection Act,” was passed by the General Assembly and now heads to the Governor’s desk for signature.

The act would require certain individuals to report the occurrence or suspected occurrence of financial exploitation of persons who are age 60 and over or those with a disability between the ages of 18 and 59 years old.

According to the legislation, if a qualified individual, a person associated with a broker-dealer who serves in a supervisory, compliance or legal capacity, believes that financial exploitation is taking place, or being attempted, the individual must notify Rhode Island’s Department of Business Regulation and Division of Elderly Affairs, and law enforcement. The individual may also alert immediate family members, legal guardians, conservators, or agents under a power of attorney of the person possibly being financially exploited.

The legislation also calls for the Department of business Regulation and the Division of Elderly Affairs to develop websites that include training resources to assist in the prevention and detection of financial exploitation against Rhode Island’s seniors and disabled.

Combating Alzheimer’s Disease

With the number of persons with Alzheimer’s Disease expected to increase in the coming years, the General Assembly approved bills to better support Rhode Islanders affected by debilitating mental disorder and to protect against elder abuse. There are an estimated 23,000 Rhode Islanders age 65 and older living with Alzheimer’s disease. In just six years, the number is expected to increase to 27,000.

The Rhode Island General Assembly approved legislation (S 20223, 2019-H 5178) sponsored Sen. Cynthia A.Coyne, D-Barrington, Bristol, East Providence, and House Majority Leader K. Joseph Shekarchi, D-Warwick, to establish a program within the Department of Health dedicated to Alzheimer’s disease, and create a 13-member advisory council that would provide policy recommendations, evaluate state-funded efforts for care and research and provide guidance to state officials on advancements in treatment, prevention and diagnosis. The bill is based on legislation signed into law last year in Massachusetts.

The legislation requires the Department of Health to assess all state programs related to Alzheimer’s, and maintain and annually update the state’s plan for Alzheimer’s disease. It would also require the Department of Health to establish an Alzheimer’s disease assessment protocol specifically focused on recognizing the signs and symptoms of cognitive impairments, and appropriate resource information for effective medical screening, investigation and service planning. The legislation would also require caseworkers working with the Department of Elderly Affairs to become familiar with those protocols. Additionally, the legislation would require a one-time, hourlong training on diagnosis, treatment and care of patients with cognitive impairments for all physicians and nurses licensed in the state.

Most importantly, adoption of the legislation would enable Rhode Island to qualify for federal funding that is available to help states with their efforts to support those with Alzheimer’s disease.

Also gaining final Rhode Island General Assembly approval was legislation (2019-S 0302A, 2019-H 5141) sponsored by Sen. Coyne and Rep. Joseph M. McNamara, D-Warwick, Cranston, to allow the spouses or partners of patients residing in Alzheimer’s or dementia special care unit or program to live with them, even if they do not meet the requirements as patients-themselves.

Finally, Sen. Coyne, who lead the Senate’s Special Task Force to Study Elderly Abuse and Financial Exploitation, successfully spearheaded an effort this session to pass legislative proposals to beef up the state’s efforts to combat elder abuse, that is growing and vastly under reported. For details, go to herbweiss.wordpress.com, to access the June 30 commentary, “Senate Task Force Calls for Action to Combat State’s Growing Elder Abuse.”