A4 Study: Testing Solanezumab before Alzheimer’s Symptoms Appear

  • Healthy older adults with no symptoms of Alzheimer’s disease are the focus of a large study involving 61 medical centers across the U.S., Canada and Australia. The Anti-Amyloid Treatment in Asymptomatic Alzheimer’s study aims to find out if Eli Lilly’s solanezumab, which failed in earlier studies to help people with Alzheimer’s symptoms, will help prevent Alzheimer’s if given long before symptoms appear. Solanezumab did show some promise in the earlier clinical trials for people who had mild cognitive impairment (MCI) which can signal an early stage of Alzheimer’s disease.


    The Anti-Amyloid Treatment in Asymptomatic Alzheimer’s study is one of four NIH-supported Alzheimer’s studies to focus on innovative treatments, thus the umbrella name A4.

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    Lead researcher Reisa Sperling, professor in neurology at Harvard Medical School and director of the Center for Alzheimer Research and Treatment at Brigham and Women’s Hospital in Boston said of the study, “Our best chance of really changing the disease is to start treatment before people have symptoms.”


    According to the Alzheimer’s Association, more than 5 million Americans are currently living with Alzheimer’s. Without medical breakthroughs to prevent, slow or stop the disease, they predict that the number will rise to 13 million by 2025.


    It’s been known for some time that Alzheimer’s may start decades before there are any obvious symptoms. Since long awaited treatments to reverse the damage to the brain from Alzheimer’s disease have failed in advanced clinical trials, many researchers are anxious to see if one of those once promising new drugs may still work if given early enough in the disease process.


    The current study is compared to clearing away cholesterol to ward off heart disease, only in this case the researchers hope to clear away excess amyloid plaque that many scientists think may be the underlying cause of Alzheimer’s. Clearing away amyloid plaque is the function of solanezumab.


    Sperling and other researchers at the 61 medical centers are recruiting volunteers between the ages of 65 and 85 who are willing to have brain scans and take memory tests in order to see if they fit the criteria for the Anti-Amyloid Treatment in Asymptomatic Alzheimer’s study.


    The study will last three years during which time the volunteers who qualify will be given monthly infusions of solanezumab or a placebo. The volunteers will be tracked the entire time for amyloid levels and memory issues. Volunteers in this study won’t be told whether or not they are getting solanezumab or a placebo until the three-year study ends.


    Although amyloid plaque is present in all those who have Alzheimer’s, not everyone with plaque develops the disease. Scientists aren’t sure whether the plaque causes the disease or is simply a by-product of it. The hope is that the A4 studies will clarify some of the confusion that surrounds the cause of Alzheimer's disease.

    This study is one of many that require healthy older adults to volunteer for clinical trials. While many of us feel helpless to do anything positive in the fight against Alzheimer’s, volunteering for studies is one way to contribute. The National Institutes of Health provides information on these clinical trials, so check into it if you’re interested in doing your part.


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    Agnvall, E. (2014, June 17) Major New Study Tests Drug to Prevent Alzheimer’s Disease. AARP. Retrieved from http://blog.aarp.org/2014/06/17/new-study-tests-drug-to-prevent-alzheimers-disease/

    NIH (2013, January 4) NIH-supported Alzheimer’s studies to focus on innovative treatments. Alzheimer’s Disease Cooperative Study group will undertake four clinical trials over five years. Retrieved from http://www.nih.gov/news/health/jan2013/nia-14.htm

    Alzheimer’s Association (2014, March 5) Alzheimer's Association awards largest-ever research grant to expand A4 Alzheimer's prevention trial. Retrieved from http://www.alz.org/news_and_events_a4_alzheimers_prevention.asp

Published On: June 26, 2014