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alzheimers

Banner Alzheimer’s Institute partners with Novartis

Jessica Langbaum, Ph.D.

Jessica Langbaum, Ph.D.

Researchers from the Banner Alzheimer’s Institute (BAI) today announced a partnership with Novartis in a pioneering medical trial to determine whether two investigational anti-amyloid drugs—an active immunotherapy and an oral medication—can prevent or delay the emergence of symptoms of Alzheimer’s in people at particularly high risk for developing the disease at older ages.

The five-year APOE4 trial will involve more than 1,300 cognitively healthy older adults, ages 60 to 75, at high risk of developing symptoms of Alzheimer’s because they inherited two copies of the apolipoprotein E (APOE4) gene—one from each parent. About 2 percent of the world’s population carries two copies of this gene and one in four people carry one copy of the APOE4 gene, which is strongly linked to late-onset Alzheimer’s.

The trial—subject to regulatory authority approval—will begin in 2015 at approximately 60 sites in Europe and North America, including BAI’s headquarters in Phoenix, Ariz. Participants will receive either the active immunotherapy or the oral medication or a placebo.

The study is partially funded by a $33.2 million grant commitment from the National Institutes of Health (NIH), part of the U.S. Department of Health and Human Services, awarded in 2013, and
more than $15 million in philanthropic and in-kind contributions by Banner Alzheimer’s Foundation. It is part of the Alzheimer’s Prevention Initiative (API), an international collaboration led by BAI to accelerate the evaluation of promising prevention therapies.

Today’s announcement of the partnership with Novartis, a Swiss pharmaceutical company, and the selection of the drugs to be studied, represent a dramatic investment in novel approaches to Alzheimer’s prevention research.

“We hope Novartis’s substantial investment of resources and expertise will lead to a significant breakthrough in Alzheimer’s research,” said Dr. Pierre N. Tariot, study director for BAI, an arm of Banner Health, one of the largest nonprofit healthcare systems in the United States. “We are taking clinical trials to a critical new stage. This approach shifts the research paradigm from trying to reverse disease damage to attacking and preventing its cause, years before symptoms could surface.”

The active immunotherapy is aimed at triggering the body’s immune system to produce antibodies that attack different forms of the amyloid protein, which many researchers have suggested plays a critical role in the development of Alzheimer’s. The oral medication is a BACE (beta-secretase1) inhibitor, designed to prevent the production of different forms of the amyloid protein.

The two drugs, which will be tested separately, are intended to stop the accumulation of amyloid in ways that differ from the anti-amyloid antibody therapies now being tested in API’s Autosomal Dominant Alzheimer’s Disease (ADAD) trial in Colombia, and in two other prevention trials. The drugs are being introduced even before amyloid accumulates in some of the participants’ brains. The trial will increase the chance of finding treatments that will prevent, slow or delay the loss of memory and other cognitive abilities associated with Alzheimer’s.

The new study marks the second major trial associated with API. In 2012, NIH announced the long-term ADAD study of cognitively healthy individuals who are destined to develop Alzheimer’s at an unusually early age because of their genetic history. The $100 million study—funded by NIH, BAI and Genentech, a biotechnology company—is focused on approximately 300 members of an extraordinarily large family from Colombia who share a rare genetic mutation that typically triggers Alzheimer’s symptoms around age 45.

The ADAD study, a partnership of BAI, Genentech and the University of Antioquia in Colombia, is evaluating the amyloid antibody agent crenezumab.

“There are no guarantees that any of these investigational treatments will prevent the clinical onset of Alzheimer’s disease,” said Dr. Eric M. Reiman, one of the study directors for BAI. “But we are grateful for these opportunities to find out.”

The APOE4 and ADAD trials will be critical in determining whether anti-amyloid treatments are likely to show benefit for Alzheimer’s. Both trials include the best-established cognitive and biological measures of the disease, and a strategy that might make it possible to substantially shorten the time needed to conduct future prevention trials. Both trials also include precedent-setting agreements for the sharing of study data and biological samples after the studies conclude.

Volunteers for the APOE4 study will receive either active immunotherapy injections or a BACE inhibitor in pill form or a placebo. Participants will be recruited via multiple venues, including the Alzheimer’s Prevention Registry website created by BAI in 2012. The registry (www.endALZnow.org) currently has more than 37,000 potential volunteers and is aiming to recruit more than 250,000.

The APOE4 study’s new website, which will launch in 2015, will create a platform to explain the study, register potential participants and provide disclosure information and consent forms. Volunteers who meet the study criteria will be asked to mail a sample of their genetic material (such as a cheek swab) to a laboratory. The volunteers will learn the results of that test in the context of possibly enrolling in the trial.

“This web research platform creates a powerful tool for any additional Alzheimer’s research,” said Jessica Langbaum, Ph.D., co-director of the study at BAI. “This infrastructure enables us to create more than just a single drug trial, but rather a template for testing a variety of treatments for many years to come.”

Volunteers who are selected will receive genetic counseling, as will others who are not chosen but who seek more information on their vulnerability. “We are keenly aware of the extreme sensitivity and emotional impact of disclosing genetic information,” Dr. Langbaum said. Volunteers accepted into the trial will already know they are at high risk, while others may learn of a lesser but still increased risk. For both of these groups, BAI will be providing more detailed information and genetic counseling in person, by phone or possibly through video-conferencing or telemedicine.

“We are excited about the chance to partner with Novartis, which has a longstanding commitment to the fight against Alzheimer’s and promising investigational treatments. They will conduct this study in a way that will be helpful to all stakeholders in the field,” said Dr. Tariot.

“We are now coming to believe that attacking Alzheimer’s disease, before clinical signs of memory loss and cognitive impairment become evident, may provide our best chance for effective therapies,” says Dr. Neil Buckholtz, Director of the Division of Neuroscience at the NIA. “These studies will be important in helping to determine if and how that can be done.”

Alzheimer’s is a debilitating and incurable disease that affects as many as 5 million Americans age 65 and older, according to a number of estimates. Without the discovery of successful prevention therapies, the number of U.S. cases is projected to nearly triple by 2050.

alzheimers

Fundraiser launched for Banner Alzheimer’s Institute

Banner Alzheimer’s Foundation, the philanthropic resource for Phoenix-based Banner Alzheimer’s Institute (BAI), announced that it is the grateful beneficiary of a yearlong fundraising initiative from Visiting Angels Scottsdale.

Contributions from the non-medical home care services provider catering to seniors, including those with Alzheimer’s disease and other dementias, will support Alzheimer’s prevention research via the foundation’s $40 million The BAI Breakthrough campaign.

The fundraising endeavor with Visiting Angels Scottsdale includes donating 3 percent of the company’s operating revenues from memory care services over a 12-month period to Banner. The initiative will result in a donation of up to $25,000.

“About 70 percent of our patients are living with Alzheimer’s disease or struggle with another memory issue,” explained Mark Aspenson, executive director of Visiting Angels Scottsdale. “Seeing firsthand the impact Alzheimer’s has on our patients and their loved ones compelled us to help support Banner Alzheimer’s Institute in its quest to end this heartbreaking disease.”

Visiting Angels Scottsdale began allocating revenues from its memory care services to apply toward the one-year commitment on May 1.

“In philanthropy, there are often ‘natural partners’ brought together by a shared commitment to making things better,” said Andy Kramer Petersen, president and CEO of Banner Alzheimer’s Foundation. “The tremendous work Visiting Angels Scottsdale does each day to help care for and improve quality of life for those touched by Alzheimer’s aligns so closely with the mission and vision of BAI. We’re honored to call Visiting Angels Scottsdale a partner.”

Learn more about The BAI Breakthrough and ways to support Banner Alzheimer’s Institute at www.BannerAlz.org/WaysToGive or by calling Banner Alzheimer’s Foundation at (602) 747-4483 (GIVE).

alzheimers

Flinn Awards $2M to Banner Alzheimer’s Institute

Banner Alzheimer’s Foundation, the philanthropic resource for Phoenix-based Banner Alzheimer’s Institute (BAI), part of the nonprofit Banner Health, received $2 million in grant funding from the Flinn Foundation, a privately endowed, philanthropic grantmaking organization in Arizona.

Aligning with the Flinn Foundation’s mission to advance biosciences in the state, the grant is an investment in BAI’s groundbreaking Alzheimer’s prevention research. Specifically, the funds will support activities related to the Alzheimer’s Prevention Initiative. A global Alzheimer’s prevention research endeavor spearheaded by scientists and physicians at BAI, the Alzheimer’s Prevention Initiative has been described by the director of the National Institutes of Health as a “cornerstone in the national plan to address Alzheimer’s disease.”

“The Flinn Foundation is an invaluable part of the fabric of Arizona’s philanthropic community, investing in organizations and programs with a track record for advancing research, civic leadership, and arts and culture in our state,” noted Andy Kramer Petersen, president and CEO of Banner Alzheimer’s Foundation. “We are honored that they recognize the tremendous potential of the Alzheimer’s Prevention Initiative and value the work being done at BAI.”

The $2 million grant to BAI is the latest in a decades-long philanthropic relationship between the Flinn Foundation and Banner Health. Prior funding supported an array of community outreach and pediatric health care programs, the most notable being Banner School-Based Health Centers, a program delivering primary health care services to children and adolescents throughout the greater Phoenix area who lack health insurance and access to regular care.

To learn more about BAI, the Alzheimer’s Prevention Initiative, and corresponding local and global research efforts, visit www.BannerAlz.org. For more information about giving opportunities, please call Banner Alzheimer’s Foundation at (602) 747-4483 (GIVE).

Medical Technology - AZ Business Magazine January/February 2012

Banner Alzheimer’s Foundation Honor Lavidges

Banner Alzheimer’s Institute (BAI), and its nonprofit Banner Alzheimer’s Foundation, will present its 2013 “Powerful Mind Award” to Bill and Julie Lavidge at its annual fete and fund-raiser, “A Night to Remember,” on Saturday, Oct. 19 at the Musical Instrument Museum.

Bill Lavidge is CEO of The Lavidge Company (TLC), a full-service advertising, public relations, communications, consulting and interactive marketing agency. Bill and Julie serve as Vice Chairs of The BAI Breakthrough Campaign Cabinet, a $40 million fund-raising initiative to help fund groundbreaking Alzheimer’s research and support BAI’s nationally recognized care model for patients and families made possible by philanthropic investments from individuals, corporations and foundations. The campaign was launched in 2011. In addition, Julie Lavidge serves on the Banner Alzheimer’s Foundation Board of Directors and is a founding member of Women Inspiring Scientific Progress (WISP), a Phoenix-based community group dedicated to advancing Alzheimer’s research through education and advocacy.

Each year, BAI recognizes outstanding contributions from member volunteers and honors them with the Powerful Mind Award. Last year’s recipient was Gene D’Adamo, vice president of community relations for Republic Media, which operates The Arizona Republic and 12 News.

“We are proud to be involved in such a great organization like Banner Alzheimer’s Institute and are humbled to receive the Powerful Mind Award,” said Bill Lavidge. “The pioneering research being done at BAI is truly groundbreaking and inspiring. We believe there are many deserving candidates for this award and we are grateful for the recognition.”

The Breakthrough Campaign is a collaboration between a team of renowned scientists and clinicians and an outstanding group of individuals, corporations and foundations dedicated to funding the breakthrough that could change lives for generations to come.

“Bill and Julie exemplify the spirit of selflessness and dedication necessary to foster great change and even greater outcomes,” remarked Andy Kramer-Petersen, president and CEO of Banner Alzheimer’s Foundation. “The way they have, for years, rallied around the cause, given of their time and talents, and engaged others in the mission to end Alzheimer’s is admirable and most certainly a powerful reminder of the impact we can all make.”

More information about The BAI Breakthrough and the work being done at BAI can be found at www.banneralz.org.

Through its research and care, Banner Alzheimer’s Institute is dedicated to the goal of ending Alzheimer’s disease without losing another generation. It is helping to launch a new era of Alzheimer’s research – treatment and prevention at the pre-symptomatic stage – and to establish a new comprehensive model of care. Established in 2006 by Banner Health, one of the country’s largest nonprofit health care systems, BAI has a three-fold focus: to conduct revolutionary studies in the detection, treatment and prevention of Alzheimer’s; to set a national standard of patient and family care; and to forge scientific collaborations that bring together institutions and disciplines internationally.

alzheimers

NIH grants Banner Alzheimer’s Institute $33M

In collaboration with the National Institutes of Health (NIH), Banner Alzheimer’s Institute (BAI) announces a major prevention trial to evaluate a treatment in cognitively healthy older adults at the highest known genetic risk for developing Alzheimer’s disease at older ages. An NIH grant, expected to total $33.2 million, will support this research.

The study is part of the Alzheimer’s Prevention Initiative (API), an international collaboration led by BAI to accelerate the evaluation of promising but unproven prevention therapies. It will test an anti-amyloid treatment in about 650 adults, ages 60-75, who have two copies of the apolipoprotein E (APOE4) gene, the major genetic risk factor for late-onset Alzheimer’s. None of the participants will have impairments in memory or thinking at the time they enter the study.

“Once again, we are extremely grateful to the NIH for the opportunity to help accelerate the evaluation of treatments to prevent the clinical onset of Alzheimer’s and find ones that work as soon as possible,” said Dr. Eric M. Reiman, BAI Executive Director. “This trial will allow us to extend our work to individuals at greatest risk at older ages.”

The randomized, placebo-controlled trial, which will take place at BAI and other U.S. sites, will test the treatment’s ability to stave off the memory and thinking declines associated with Alzheimer’s. It will also assess the treatment’s effects on different brain imaging and cerebrospinal fluid measurements of the disease. The specific compound to be evaluated has not been decided.

The trial will test what is often called the amyloid hypothesis, which suggests that accumulation of the protein amyloid in the brain plays a key role in the disease’s progression.  Major funding from philanthropy and industry will also support the trial, and its leaders expect to provide data and biological samples to the research community after the trial’s conclusion to help in the scientific fight against Alzheimer’s.
Individuals in the study will learn their APOE4 status. To help them prepare for this information, BAI has convened an expert committee to develop a comprehensive genetic testing and disclosure plan and to assess the impact of this disclosure during the trial.
“Under the National Plan to Address Alzheimer’s Disease, our goal is to prevent and effectively treat the disorder by 2025,” said Dr. Neil Buckholtz, of the National Institute on Aging, which leads Alzheimer’s research at the National Institutes of Health.  “We are delighted to support Dr. Reiman, Dr. Tariot and their team in this innovative clinical trial aimed at preventing the onset and progression of this devastating disease.”

The research is intended to complement API’s initial trial, which is primarily focused in Colombia and involves about 300 people from an extended family with a rare genetic mutation that typically triggers Alzheimer’s symptoms around age 45. That work also is focusing on an anti-amyloid therapy and its potential in slowing or blocking the disease while preserving cognitive abilities. The investigation, including a smaller U.S. companion study, dovetails with prevention trials that have been planned or started by other research groups during the past 16 months.
“We are now looking at potential treatments to prevent both the early and late onset forms of the disease,” said Dr. Pierre N. Tariot, BAI Director. “This kind of comprehensive approach could prove the tipping point in our long, arduous effort to find a way to end this devastating disease.”

The new trial will draw participants mainly from the Alzheimer’s Prevention Registry (www.endALZnow.org), an online community of people who are committed to helping in the fight against Alzheimer’s. The Registry provides regular updates on the latest scientific advances, as well as information on overall brain health. To overcome one of the biggest obstacles to clinical research, the Registry supports enrollment in a variety of Alzheimer’s prevention studies within members’ communities.

Alzheimer’s is a debilitating and incurable disease that affects more than 5.2 million Americans, with a new diagnosis every 68 seconds. Without the discovery of successful prevention therapies, the number of U.S. cases is projected to nearly triple by 2050.

alzheimers

NIH grants Banner Alzheimer's Institute $33M

In collaboration with the National Institutes of Health (NIH), Banner Alzheimer’s Institute (BAI) announces a major prevention trial to evaluate a treatment in cognitively healthy older adults at the highest known genetic risk for developing Alzheimer’s disease at older ages. An NIH grant, expected to total $33.2 million, will support this research.

The study is part of the Alzheimer’s Prevention Initiative (API), an international collaboration led by BAI to accelerate the evaluation of promising but unproven prevention therapies. It will test an anti-amyloid treatment in about 650 adults, ages 60-75, who have two copies of the apolipoprotein E (APOE4) gene, the major genetic risk factor for late-onset Alzheimer’s. None of the participants will have impairments in memory or thinking at the time they enter the study.

“Once again, we are extremely grateful to the NIH for the opportunity to help accelerate the evaluation of treatments to prevent the clinical onset of Alzheimer’s and find ones that work as soon as possible,” said Dr. Eric M. Reiman, BAI Executive Director. “This trial will allow us to extend our work to individuals at greatest risk at older ages.”

The randomized, placebo-controlled trial, which will take place at BAI and other U.S. sites, will test the treatment’s ability to stave off the memory and thinking declines associated with Alzheimer’s. It will also assess the treatment’s effects on different brain imaging and cerebrospinal fluid measurements of the disease. The specific compound to be evaluated has not been decided.

The trial will test what is often called the amyloid hypothesis, which suggests that accumulation of the protein amyloid in the brain plays a key role in the disease’s progression.  Major funding from philanthropy and industry will also support the trial, and its leaders expect to provide data and biological samples to the research community after the trial’s conclusion to help in the scientific fight against Alzheimer’s.
Individuals in the study will learn their APOE4 status. To help them prepare for this information, BAI has convened an expert committee to develop a comprehensive genetic testing and disclosure plan and to assess the impact of this disclosure during the trial.
“Under the National Plan to Address Alzheimer’s Disease, our goal is to prevent and effectively treat the disorder by 2025,” said Dr. Neil Buckholtz, of the National Institute on Aging, which leads Alzheimer’s research at the National Institutes of Health.  “We are delighted to support Dr. Reiman, Dr. Tariot and their team in this innovative clinical trial aimed at preventing the onset and progression of this devastating disease.”

The research is intended to complement API’s initial trial, which is primarily focused in Colombia and involves about 300 people from an extended family with a rare genetic mutation that typically triggers Alzheimer’s symptoms around age 45. That work also is focusing on an anti-amyloid therapy and its potential in slowing or blocking the disease while preserving cognitive abilities. The investigation, including a smaller U.S. companion study, dovetails with prevention trials that have been planned or started by other research groups during the past 16 months.
“We are now looking at potential treatments to prevent both the early and late onset forms of the disease,” said Dr. Pierre N. Tariot, BAI Director. “This kind of comprehensive approach could prove the tipping point in our long, arduous effort to find a way to end this devastating disease.”

The new trial will draw participants mainly from the Alzheimer’s Prevention Registry (www.endALZnow.org), an online community of people who are committed to helping in the fight against Alzheimer’s. The Registry provides regular updates on the latest scientific advances, as well as information on overall brain health. To overcome one of the biggest obstacles to clinical research, the Registry supports enrollment in a variety of Alzheimer’s prevention studies within members’ communities.

Alzheimer’s is a debilitating and incurable disease that affects more than 5.2 million Americans, with a new diagnosis every 68 seconds. Without the discovery of successful prevention therapies, the number of U.S. cases is projected to nearly triple by 2050.

banner alzheimers foundation - brain research

Banner Alzheimer’s Institute to open $16.3M Imaging Center

The opening of a $16.3 million state-of-the-art Imaging Center further cements the internationally-recognized work occurring at Banner Alzheimer’s Institute (BAI) and advances statewide collaboration in Alzheimer’s disease and other neuroscientific, cardiology and oncology research.

The Imaging Center, located at BAI’s campus in Phoenix, was made possible by $9.2 million in funding from the National Institutes of Health and $7.1 million in philanthropic support from individuals, corporations and foundations. The center, which opens later this spring, will provide a shared scientific resource for researchers throughout the state and it will complement the scientific strengths of its partnering institutions.

The 18,000-square-foot facility features state-of-the-art imaging equipment including positron emission tomography (PET), CT and MRI technology. In addition, a cy*clotron and radiochemistry lab will allow the production of radiotracers to support PET studies across Arizona in the areas of neurology, oncology and cardiology. Radiotracers are used by PET researchers to study a range of biochemical and physiological processes in the brain and body.  In addition, BAI’s computational analysis laboratory will continue to develop, test, and use software to analyze PET and MRI images with unprecedented power.

“We are grateful to the National Institutes of Health, and extraordinary charitable contributions facilitated by Banner Alzheimer’s Foundation for the state-of-the-art imaging resources needed to make potentially transformational differences in the scientific fight against Alzheimer’s disease, advance cancer research, unravel mysteries of the human mind and brain and support important biomedical research collaborations throughout the state,” said Dr. Eric Reiman, CEO of Banner Research, BAI executive director, and director of the Arizona Alzheimer’s Consortium.

The new Imaging Center will help BAI researchers in the effort to find treatments to ending Alzheimer’s before it impacts another generation. It will also add to the arsenal of research tools used by researchers in the Arizona Alzheimer’s Consortium, a leading model of statewide collaboration in biomedical research.

“Members of Arizona Alzheimer’s Consortium played a huge role in our effort to secure funding for the Imaging Center and will continue to be key participants in our imaging research,” added Reiman.

The Arizona Alzheimer’s Consortium includes Arizona State University, Barrow Neurological Institute, Mayo Clinic Arizona, Banner Sun Health Research Institute, Translational Genomics Research Institute (TGen), University of Arizona and Banner Alzheimer’s Institute.

In addition to the new Imaging Center, Dr. Reiman, Dr. Pierre Tariot, and their colleagues have developed the international Alzheimer’s Prevention Initiative (API) to find effective treatments to prevent Alzheimer’s disease as quickly as possible. With its first prevention trial launching later this year, API will begin to evaluate the most promising therapies and do so as quickly as possible. The API is intended to evaluate promising prevention therapies in individuals at the highest genetic risk for Alzheimer’s disease, help set the stage for the field to rapidly evaluate the range of promising therapies and find ones that work as quickly as possible.

A key component of API is its national Alzheimer’s Prevention Registry. People who are passionate about combatting the disease are encouraged to sign-up at https://registry.endalznow.org/. They will receive regular updates about the latest advances in the prevention of Alzheimer’s disease, the promotion of brain health, and opportunities to participate in prevention studies.

banner alzheimers foundation - brain research

Banner Alzheimers Foundation Launches $40 Million Campaign

Banner Alzheimers Foundation (BAF), the philanthropic resource for Banner Alzheimer’s Institute (BAI), announces a $40 million campaign to advance some of the most challenging yet promising research to stop Alzheimer’s disease. The BAI Breakthrough will support cutting-edge studies aimed at treating and preventing the disease, state-of-the-art brain imaging and an unparalleled model of patient and family care.

The campaign will designate $15 million to help fund the groundbreaking research that BAI recently announced in collaboration with the National Institutes of Health and others. This prevention trial, which will span two countries, will test an amyloid immunization therapy and is the first ever conducted with cognitively healthy individuals who are certain to develop Alzheimer’s because of their genetic history.

The campaign’s remaining $25 million will support additional studies of both the preclinical and symptomatic stages of the disease; critical technology for a new 18,000-square-foot imaging center; and expansion of BAI’s comprehensive model of care to serve as the standard nationwide.

The BAI Breakthrough officially launched this spring with a $6 million gift from the Stead Family Foundation. Mary Joy and Jerre Stead are long-time supporters of BAI and chairs of the campaign’s leadership cabinet. He is also chairman of the BAF board.

“We absolutely believe prevention of Alzheimer’s will become a reality through BAI’s research efforts,” Jerre Stead says. “Yet, not only is BAI working on behalf of future generations, it is taking care of individuals and families dealing right now with the impact of this devastating disease. Mary Joy and I feel privileged to be a part of this effort and encourage others to get involved.”

About 5.4 million Americans are currently living with Alzheimer’s, a debilitating and incurable disease of the brain. By 2030, that number could exceed 7.7 million, and by 2050, as many as 16 million Americans could have Alzheimer’s. The disease takes an enormous physical, emotional and financial toll on individuals, caregivers and families.

Dr. Eric Reiman, BAI executive director and CEO of Banner Research, applauds the role that philanthropy is playing here in advancing research and care.

“We could not be more grateful to Jerre and Mary Joy Stead for their leadership, passion and extraordinary support—and to so many people who provide the resources needed for us to fulfill our ambitious goals,” Reiman says. “Their support makes it possible for BAI to provide hope and help, research and care, and to give us the chance to make a transformational difference in the fight against Alzheimer’s disease.”

The campaign is a collaboration between a team of renowned scientists and clinicians and an outstanding group of individuals, corporations and foundations dedicated to funding the breakthrough that could change lives for generations to come.

More information about Banner Alzheimers Foundation and The BAI Breakthrough or the work of BAI can be found at www.banneralz.org.

prevention trial - brain scan images

Alzheimer’s Prevention Trial Announced

In collaboration with the National Institutes of Health (NIH), Banner Alzheimer’s Institute (BAI), University of Antioquia in Colombia and Genentech, a member of the Roche Group, announce the first-ever prevention trial in cognitively healthy individuals who are destined to develop Alzheimer’s disease because of their genetic history. This groundbreaking study—the first to investigate whether an anti-amyloid treatment can stave off the disease—will span two countries and help launch a new era of prevention research in the urgent fight against Alzheimer’s.

The $100 million trial is the cornerstone of a new international collaborative, the Alzheimer’s Prevention Initiative (API), formed to accelerate the evaluation of promising but unproven prevention therapies. It will study an experimental anti-amyloid antibody treatment called crenezumab in approximately 300 people from an extraordinarily large extended family in Colombia, who share a rare genetic mutation that typically triggers Alzheimer’s symptoms around age 45. The trial will also include a smaller number of individuals in the United States. The API team will collaborate with researchers from the NIH-supported Dominantly Inherited Alzheimer’s Network (DIAN) to identify and recruit the U.S. participants.

The trial is designed to determine whether the drug can reduce participants’ chances of developing the disease’s disabling and irreversible symptoms, preserve memory and thinking abilities, and slow the progression of Alzheimer’s biomarkers.

Drs. Eric M. Reiman and Pierre N. Tariot from the Phoenix-based BAI lead the broader initiative, and they also will be leading the trial in close cooperation with Genentech’s research and clinical team and a Colombian team headed by Dr. Francisco Lopera of Grupo de Neurociencias de Antioquia at the University of Antioquia. Together, these three groups designed the study with input from other prominent scientists and NIH and regulatory officials.

If crenezumab is shown to sustain memory and cognition in people certain to develop Alzheimer’s, prevention trials could be designed to test it and other anti-amyloid drugs in a larger segment of the population. If the treatment’s effects on brain imaging and other biological measurements of the disease are shown to predict its clinical benefit, the study could establish a much more rapid way to test future therapies.

“We are grateful for the chance to evaluate such a promising prevention treatment,” said Dr. Reiman, BAI Executive Director. “We have tried to design the study in a way that might bring the field closer to ending Alzheimer’s before another generation is lost.”

The study will be supported with five-year NIH funding expected to total $16 million, as well as a BAI commitment of $15 million in philanthropic funds. Genentech will contribute the major share of funding, in addition to providing study drug and clinical and operational expertise integral to the design and conduct of the study. Given the importance of the trial, data and findings will be shared publicly after its completion to help the entire Alzheimer’s research community find faster ways to test promising prevention therapies.

“Genentech is very excited to be a part of this landmark effort,” said Richard H. Scheller, PhD, Executive Vice President, Research and Early Development at Genentech. “If the study demonstrates that we can prevent the disease in this special group of patients, it may pave the way to preventing Alzheimer’s in the general population.”

About 5.4 million Americans are living with Alzheimer’s today, a number expected to top 7.7 million by 2030. Globally, the disease and other dementias are expected to affect nearly 66 million by then.

The study represents a marked shift in researchers’ approach to detecting, treating and ultimately preventing Alzheimer’s. Many in the clinical and scientific community believe that by the time memory begins to slip and confusion and other thinking problems emerge, too much damage may already have occurred for some treatments, such as those focusing on amyloid, to be effective. They suspect that these potential therapies must instead be started before the onset of symptoms.

BAI researchers already have shown how advanced brain imaging, biomarkers and other measurements can identify and track subtle Alzheimer’s-associated changes in healthy people at genetic risk for the disease many years before its first clinical signs appear. They proposed using these tools in a prevention trial that would not require a lengthy wait for those symptoms.

The new study will test what is often called the amyloid hypothesis, which suggests that accumulation of the protein amyloid in the brain plays a key role in the progression of Alzheimer’s disease.

Preclinical studies indicate that crenezumab, an antibody therapy that Genentech is developing in collaboration with Swiss biotech company AC Immune SA, works by binding to amyloid proteins and clearing them from the brain. It has been studied in both healthy individuals and people with Alzheimer’s and currently is being evaluated in a Phase II clinical study in patients with mild to moderate symptoms. No significant safety issues have been detected to date. The drug was selected for this prevention trial with guidance from an expert advisory panel.

“The trial represents big hope for the people here,” Dr. Lopera said from Medellín, where he has followed generations of the families since the early 1980s. “For those with the genetic mutation, it is a chance to modify their destiny. For those who are not carriers, it is a chance to save loved ones. They all want a far different future.”

Among the Colombian as well as U.S. participants, crenezumab will be administered to individuals 30 and older with normal cognitive function. Participants in the double-blind, placebo-controlled trial will receive an injection of crenezumab or placebo at set intervals for up to five years. Researchers will use advanced imaging techniques, cerebrospinal fluid tests and sensitive cognitive measures to monitor whether the accumulation of amyloid and other tell-tale proteins in the brain is reduced, whether brain size and function is maintained, and, most importantly, whether mental performance is preserved.

To avoid signaling the genetic status of participants, most of whom do not want to know if they have the   mutation, the study will include relatives who are non-carriers and will receive the placebo.

“We are cognizant of the responsibility that we face, not just to the scientific community but to the families who will be involved in our work,” said Dr. Tariot, BAI Director. “Yet the possibilities ahead are tremendous. If this approach to fighting Alzheimer’s is successful, it has the potential to transform all future prevention and treatment research and to herald the beginning of the end of this devastating disease.”

For more information on the Alzheimer’s Prevention Initiative, visit Alzheimer’s Prevention Initiative’s website at endalznow.org.