The trials will use a mixture of cognitive tests on participants and biomarker datasuch as brain imaging and cerebrospinal fluid monitoringto detect effects. A4 is a new secondary prevention trial effort aimed at treating older. Intervention prior to dementia widespread irreversible brain cell loss may have. Reisa sperling, md harvard medical school, brigham and womens hospital, massachusetts general hospital. Neuroimaging in alzheimers disease why we need standardization.
Everyone is now able to get the drug once theyve finished the doubleblind phase of the trial. In addition, the a4 clinical trial currently includes an outcome measure, the cfi amariglio et al. The presubiculum links incipient amyloid and tau pathology to memory function in older persons. Reisa sperling, md, is using neuroimaging to ask whether antiamyloid antibody treatment can reverse alzheimers disease pathology before memory loss sets in. Phase iii trial failures at stage of ad dementia over the past decade. The a4 study is a secondary prevention trial that will test the hypothesis that an antiamyloid treatment can slow cognitive decline in amyloidpositive older individuals at high risk for progression to the symptomatic phases of ad. Aug 31, 2012 this is a thornier trial, says a4 trial colead reisa sperling of the harvard medical school, usa, in part because there is less certainty about which subjects will decline and when.
Johnson,1,2,3 jason karlawish,4 michael donohue,5 david p. Sperlings 551 research works with 30,603 citations and 4,930 reads, including. Led by principal investigator reisa sperling, md, director of the center for alzheimer research and treatment at brigham and womens hospital bwh, the antiamyloid treatment in asymptomatic alzheimers a4 study is a landmark international clinical trial evaluating the efficacy of antiamyloid treatment in preventing memory loss due to. Sperling, who is colead investigator of the a4 trial see current clinical trials later in this article intends to pursue nonamyloid as well as amyloid targets, expecting that the a4 trial design will serve as a platform for future secondary prevention trials with other. At the 2017 clinical trials on alzheimers disease meeting, held november 14 in boston, sharon sha of stanford university in palo alto, california, presented results of a small phase 1 trial in which patients with mild to moderate ad received infusions of plasma donated by young men. Harvard researchers plot early attack against alzheimers. Reisa sperling is leading a study into a new drug treatment that could. This clinical trial is for people who show the earliest changes of amyloid in the brain but are still functioning normally on cognitive testing. After disappointments, alzheimers researchers seek out new paths. Mar 28, 2014 reisa sperling, md, provides an overview on alzheimers disease dementia and a new groundbreaking study, the antiamyloid treatment in asymptomatic alzheimers disease a4 study. The a4 trial will be conducted through the adcs utilizing 60 sites in the united states, canada, and australia. Antiamyloid treatment of asymptomatic alzheimers disease find, read and cite all the research you need on. Despite these questions, sperling, aisen, and rentz agree that theres a sense of hope in the alzheimers community, a feeling that progress in several areas has put science on the verge of a. Alzheimers study fears revealed in ucsd emails the san.
Alzheimers trial screening data links high amyloid levels with early. Many alzforum readers have heard some reference about the antiamyloid treatment in asymptomatic trial, or a4 for short. Funding partners the a4 study is a publicprivatephilanthropic partnership, including funding from the national institutes of health national institute on aging, eli lilly and company, alzheimers. Researchers will use imaging and memory tests to compare people without amyloid plaques to the placebo group in the a4 study. Early detection and prevention of alzheimers disease. Sperling says, and are now asking whether, if you intervene at this stage, you can actually change the course of the disease.
And this is a very large, over 1,000person trial in. Development of a process to disclose amyloid imaging. Alzheimers researcher reisa sperling of harvard medical school, who leads the a4 study and a companion study called longitudinal evaluation of amyloid risk and neurodegeneration, or learn. A4 and learn alzheimer trials brigham and womens hospital. Importance the antiamyloid treatment in asymptomatic alzheimer disease a4 study is an ongoing prevention trial in clinically normal older individuals with evidence of elevated brain amyloid. Sperling and her coprincipal investigator, paul aisen, md, of the university of southern californias alzheimers therapeutic research institute, envision the a4 trial design serving as a platform for additional secondary prevention trials with other antiamyloid agents. Years before clinical onset 0 5 10 15 2030 20 10 0 10 20 mutation carriers noncarriers bateman et. Reisa sperling discussed the importance of secondary prevention to delay the progression from brain pathology to dementia, which could cut health care costs significantly, and reported on her work on the antiamyloid treatment in asymptomatic ad a4 study. Reisa sperling, director of the center for alzheimer research and. Olivia okereke on page 4 for tips on healthy aging, and read more about our centers collaboration on the decadeslong nurses health study one of the largest studies of womens health that has. Nihsupported alzheimers studies to focus on innovative. Jaimes, bs marta marquiesayagues, md elena ratti, md. She is a professor in neurology at harvard medical school. The antiamyloid treatment in asymptomatic alzheimers study a4 study.
The reasons for low representation of african american and hispanic individuals in the a4 trial are multifactorial. Apr 04, 2017 sperling and her grandfather, irving, whose battle with alzheimers first inspired sperling to go into neurology. Years before clinical onset 0 5 10 15 2030 20 10 0 10 20 mutation carriers noncarriers bateman et al. The a4 study is a publicprivatephilanthropic partnership, including funding from the national. The large number of participants screened with amyloid positron emission tomography pet and standardized assessments provides an unprecedented opportunity to evaluate factors associated with elevated. A4 trial, the antiamyloid treatment in asymptomatic alzheimers disease, that was a mouthful so we. Center for alzheimers research and treatment brigham and womens hospital harvard aging brain study massachusetts general hospital harvard medical school. Clinical trials on alzheimers disease 2017 alzforum. Researchers will use imaging and memory tests to compare people without amyloid plaques to. The a4 study antiamyloid treatment in asymptomatic alzheimers disease.
The trial will enroll people age 70 or older who test positive on a scan of amyloid accumulation in the brain, explains reisa sperling of harvard university, one of the principal investigators. Biorepository develop innovative trial design methods, outcomes and analysis strategies. The alzheimers disease cooperative study adcs is partnering with eli lilly and company to conduct. Unlike api and dian, the a4 trial will attempt to prevent the far more common form of alzheimers disease thats not caused by a gene mutation. Jul 01, 2014 the a4 study is a secondary prevention trial that will test the hypothesis that an antiamyloid treatment can slow cognitive decline in amyloidpositive older individuals at high risk for progression to the symptomatic phases of ad. Sperling, md, coprincipal investigator of the a4 trial and director of the center for alzheimer research and treatment at brigham and womens hospital in boston. The a4 study is a threeyear, placebo controlled, randomized clinical trial conducted in older individuals with. We are going beyond looking for evidence of preclinical alzheimers disease, dr. Louis, and presented this work at the clinical trials on alzheimers disease conference, held.
Writing for the a4 study team, lead author reisa a. Reisa sperling, md, director of the center for alzheimers. Early detection and prevention of alzheimers disease white paper. New nih consortium award to enhance clinical trials for. The a4 study is funded by a publicprivate partnership, including the national institute on aging, eli lilly and company, the alzheimers association, and several philanthropic organizations. The a4 trial the overall goal of the a4 study is to determine whether decreasing amyloid burden in clinically.
The a4 study will be conducted across 60 sites in the u. Reisa sperling is a neurologist, specializing in dementia and imaging research. Led by principal investigator reisa sperling, md, director of the center for. Researchers will try an antiamyloid drug on people who show no signs of cognitive decline, but who do have abnormally. This information is current as of august 7, 2018 and will be updated periodically. Just last week, the study met its enrollment target, and now has 1151 cognitively normal participants between the ages of 65 and 85 enrolled. Early detection and prevention of alzheimers disease video.
Neurology and neurosurgery advances brigham and womens. That is, people who have evidence of early alzheimers disease in their brain, but dont yet have symptoms. One factor is comorbidity, such as an autoimmune disease, that excludes some individuals from eligibility reisa sperling, md, email communication, november 10, 2016. The trial, which will also be supported by private sector contributions, will provide important information about the effectiveness of clearing amyloid from the brain in the early stages of the disease and inform future prevention studies.
A4 trial, a 3 year secondary prevention trial in clinically normal older individuals with biomarker evidence of early ad pathology. There is something you can do about alzheimers diseasejoin. This is a thornier trial, says a4 trial colead reisa sperling of the harvard medical school, usa, in part because there is less certainty about which subjects will decline and when. Sperling leads the antiamyloid treatment in asymptomatic alzheimers a4 study, now underway at 67 sites in the united states, canada, and australia. Genentechs alzheimers antibody trial to study disease. What were really powered to do, with 500 per arm, is to see a difference in the slope of decline, in the rate of decline, says reisa sperling, a harvard neurologist who heads the a4 trial. The a4 study started enrollment in late february 2014, and will screen up to 5000 participants to find older individuals who qualify for enrollment into the trial. Harvard medical labcast october 2015 the aword reisa sperling. A4 researchers raise solanezumab dosage, lengthen the trial. Early detection and prevention of alzheimers disease white.
This clinical trial is for people who show the earliest changes of amyloid in the brain but are still functioning normally. Secondary prevention trial in clinically normal older individuals age 6585 who have evidence of amyloidb pathology on screening pet imaging. Abstract objective to clarify the preclinical stage of alzheimers disease by estimating when amyloid accumulation first becomes associated with changes in cognition. Reisa sperling of harvard, more about reisa in just a second. The a4 study antiamyloid treatment in asymptomatic. We tried to design the study to be at the tipping point between these two possibilities, says reisa sperling, a neurologist at harvard medical school who is leading the a4 trial. Sperling is a principal investigator of this study, which is testing the effectiveness of solanezumab, an antibody that helps remove amyloid from the brain. Welcome to alzheimers talks on this sunny, here in washington, friday afternoon, presented by usagainstalzheimers. Testing whether early treatment can change the course of. Advisory council january 2018 meeting presentation. Well thank you so much george for having me and thanks to all of you on the line who are willing to spend your friday afternoon this way.
Mar 19, 2014 the a4 study is a threeyear, placebocontrolled, randomized clinical trial conducted in older individuals with evidence of amyloid accumulation on screening pet scans, that will test whether antiamyloid treatment can slow the rate of cognitive decline on a composite measure of sensitive neuropsychological tests. The a4 study antiamyloid treatment in asymptomatic alzheimers. Alzheimers talks what if we could stop alzheimers before. Antiamyloid treatment in asymptomatic ad trial alzforum. The a4 study is a threeyear, placebocontrolled, randomized clinical trial conducted in older individuals with evidence of amyloid accumulation on screening pet scans, that will test whether antiamyloid treatment can slow the rate of cognitive decline on a composite measure of sensitive neuropsychological tests. The a4 study is funded by a publicprivate partnership, including the national institute on aging, eli lilly and company, the alzheimers. The a4 study national alzheimers coordinating center. Reisa sperling, md, provides an overview on alzheimers disease dementia and a new groundbreaking study, the antiamyloid treatment in asymptomatic. Request pdf on jul 31, 2014, reisa sperling and others published the a4 trial. So this is a firstofitskind trial of what we call a secondary prevention trial. After disappointments, alzheimers researchers seek out. The a4 trial is coordinated by the university of southern californias alzheimers therapeutic research institute, with study sites in multiple locations. A4 study team list the a4 study leadership team provides the list below for standardized acknowledgement of the many. Fight alzheimers by taking part in a clinical trial, from.
Research open access development of a process to disclose amyloid imaging results to cognitively normal older adult research participants kristin harkins1, pamela sankar2, reisa sperling3, joshua d grill4, robert c green5, keith a johnson6, megan healy1 and jason karlawish7 abstract. Reisa sperling and other alzheimers disease experts explain the a4 study, share what makes the a4 study so unique, and why now is the time to participate. Firstofitskind alzheimers disease prevention study extended. Harvard medical labcast october 2015 the aword reisa. A conceptualization of the utility of subjective cognitive. Association of factors with elevated amyloid burden in. Collaboration for alzheimers critical path institute. Sperling is a lead investigator in this study of solanezumab, an antibody that helps remove amyloid from the brain, in people ages 65 to 85 with amyloid plaques but no symptoms of dementia. Mar 19, 2014 the a4 trial will be conducted through the adcs utilizing 60 sites in the united states, canada, and australia. Recognizing that primary prevention of disease is an ultimate goal, dr. The a4 study is a landmark publicprivate partnership, funded by the national institute on agingnih, eli lilly and company, and several philanthropic organizations. The treatment appeared safe, and gave recipients a small. New set of alzheimers trials focus on prevention the lancet. Aug 17, 2012 unlike api and dian, the a4 trial will attempt to prevent the far more common form of alzheimers disease thats not caused by a gene mutation.