Tag Archives: alzheimers

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.

Dr. Oddo

New Researcher Joins Banner Sun Health Institute

Dr. Salvatore Oddo, a leader in the development of genetically-engineered mouse models and their use in the study of Alzheimer’s disease and related disorders, will join the research team at the Banner Sun Health Research Institute (BSHRI) as a Senior Scientist and as an Associate Professor in the Department of Basic Medical Sciences at the University of Arizona College of Medicine – Phoenix. Oddo comes to Arizona from the University of Texas Health Science Center at San Antonio, where he served as an assistant professor in the physiology department. He starts at BSHRI on July 1.

Oddo and his colleagues continue to develop genetically-modified mouse models and study them in the effort to clarify some of the molecular and cellular disease mechanisms responsible for Alzheimer’s disease, to discover new treatments and to help test some of the treatments that are being considered for evaluation in clinical trials. Using the “triple transgenic mouse model” that he and his colleagues first developed at the University of California, Irvine, they have already made a number of pioneering contributions to the field.

His arrival marks the first of several joint recruitments that are planned between Banner and the medical college to advance the scientific fight against Alzheimer’s disease. It also provides an opportunity to expand the resources and collaborations involved in the Arizona Alzheimer’s Consortium, the nation’s leading model of statewide collaboration in Alzheimer’s research. While Oddo’s lab will be based at BSHRI, he will work closely with his new colleagues in the medical college and other organizations in the Consortium.

“I am extremely proud to become part of a fantastic Alzheimer’s disease research team and to establish my laboratory at the Banner Sun Health Research Institute,” Oddo said. “I look forward to developing new and stimulating collaborations with the faculty to identify new therapeutic targets for this terrible disorder.”

Oddo, who earned his undergraduate degree in molecular biology from the University of Catania, Italy and his graduate degree in Neurobiology of Learning and Memory from the University of California, Irvine, has served as an assistant researcher at the University of California Irvine’s department of neurobiology and behavior. He is moving from the University of Texas Health Science Center at San Antonio where currently he is an assistant professor in the department of physiology.

“This is the first and critical step in what will be an extremely robust partnership between the Banner Sun Health Research Institute and our college,” said Stuart D. Flynn, MD, dean of the UA College of Medicine – Phoenix. “Dr. Oddo is playing an important role in the research of Alzheimer’s disease, of critical importance as we address an aging population in Arizona and beyond.”

“We are pleased to welcome someone with Dr. Oddo’s scientific caliber and extraordinary productivity,” said Marwan Sabbagh, Director of the Banner Sun Health Research Institute. “Dr. Oddo is a valuable addition to what is already a world-class team. We look forward to work ahead.”

medical.research

BIO5-TGen collaboration targets Alzheimer’s disease

BIO5 Oro Valley today announced a collaboration with the Translational Genomics Research Institute (TGen) to develop new therapies for the treatment of Alzheimer’s and other neurodegenerative diseases.

BIO5 Oro Valley co-Director and University of Arizona College of Pharmacy medicinal chemist Dr. Christopher Hulme’s collaborative effort with TGen Assistant Professor Dr. Travis Dunckley will focus on the development of novel, small molecule inhibitors of dual-specificity tyrosine phosphorylation-regulated kinase 1A (DYRK1A). Upregulation of this kinase is implicated in promoting memory deficits associated with Down syndrome and neurodegenerative pathologies, particularly Alzheimer’s disease.

“DYRK1A is a well-validated, recently discovered target, ready for translational efforts to deliver an oral medication to patients suffering from this insidious disease,” said Dr. Hulme. “Indeed, coupled with the advanced small molecules in-hand that target DYRK1A, further efforts are underway that will broaden our therapeutic presence in the Alzheimer’s arena to other Arizona-based biological discoveries.”

Statistics from the National Institutes of Health indicate that 5.1 million older Americans – or 1-in-8 – suffer from Alzheimer’s, which makes it the sixth leading cause of death in the United States and the only cause of death among the top 10 in the United States that cannot be prevented, cured or even slowed. Estimated to effect 45 million people worldwide by 2020, dementia is currently a leading, major unmet medical need and a costly burden on public health. Seventy percent of these cases have been attributed to Alzheimer’s, a neurodegenerative pathology characterized by a progressive decline in cognitive functions.

“This collaborative partnership is a critical step in advancing discoveries of the role DYRK1A plays to developing therapeutics that could alter the course of Alzheimer’s disease,” said Dr. Dunckley.

Drs. Hulme and Dunckley will focus on providing a significant alternative to common approaches that focus on small molecules that inhibit the production of neurotoxic fragments of amyloid proteins and antibody immunization approaches targeting the build up of these fragments.

The joint effort will explore the decrease of DYRK1A activity in the brain with proprietary small-molecule inhibitors. This approach could lead to new therapeutic strategies to alleviate cognitive deficits associated with Alzheimer’s and Down syndrome.

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.