| Updates about Phase III AD Trials | Kagan Program Welcomes New Clinical Trials Coordinator |
| Dear Doc... | Walk to End Alzheimer's | Clinical Trials |
Phase III Alzheimer's disease clinical trial failures…Not so fast?
By: Joshua Grill, Ph.D.
In our Autumn 2012 Newsletter, we discussed the completion and initial reporting of a series of large Phase III clinical trials of investigational agents in development for mild-to-moderate Alzheimer's dementia. Four studies of two investigational drugs, bapineuzumab and solanezumab, each found no benefit of drug, versus placebo. Secondary analyses of these studies have yielded interesting new findings that may be important to the development of bapineuzumab and solanezumab, but may be even more important to the field as a whole.
When researchers design a study, they must decide in advance how to assess if the investigational medicine is effective. This is called the primary data analysis. While primary data analyses determine if the treatment under study is effective, secondary data analyses are also important and may answer questions like does the treatment work the same in everyone? In the case of the large trials of bapineuzumab and solanezumab, the secondary analyses that were performed may represent important steps toward fully understanding if and how these medications may work and in which patients.
Secondary analyses of the Phase III studies of solanezumab that were limited to only the persons with the mildest form of dementia suggested a benefit of the drug relative to placebo. This was the case for both tests of thinking skills and tests of function (a person's abilities to perform activities of daily living). These findings suggest that solanezumab (and potentially other drugs like it, collectively referred to as immunotherapies) may be effective if given early enough in the disease. To know if this is true, these studies will need to be repeated in the specific populations that seemed to benefit.
Another possibility is to test these medications before dementia. This could include clinical trials enrolling persons with Mild Cognitive Impairment, who are at increased risk for Alzheimer's disease and dementia. It may also be possible to test medications even before cognitive impairment begins. Solanezumab has been selected as the agent to be tested in the "Anti-Amyloid Treatment in Asymptomatic Alzheimer's disease," or A4, trial. This trial, which will begin in 2013, will enroll 1000 cognitively normal persons ages 70-85 who have evidence of amyloid in their brains (measured with PET scans) and randomly assign them to solanezumab or placebo. The goal of the study is to measure whether treatment with solanezumab lowers the risk for future memory impairment.
In summary, new analyses of previous clinical trials point toward the possibility of investigational immunotherapies being effective if treatment is initiated early. The next steps will include new clinical trials that will need many participants, including older volunteers with normal memories. These new studies will be important steps toward the ultimate goal of developing improved treatments for Alzheimer's disease.
Kagan Alzheimer's Disease Treatment Development Program Welcomes New Clinical Trials Coordinator
By: Melissa Bailey
At any one time, the Easton Center conducts many research projects. For example, within the Kagan Treatment Development Program multiple studies testing the safety and efficacy of experimental medicines hoped to delay the onset, slow the progression, and reduce the symptoms of Alzheimer's disease are all in progress. Coordinating these studies is a critical role and the Easton Center recently welcomed Celine Ossinalde, M.A. to take on this role. Ms. Ossinalde comes to the Easton Center with 15 years of experience in clinical research studies. She will also aid the Center's Latino outreach programs. "I am grateful that my bilingual skills can contribute in a way that not only benefits the Center’s mission but also helps to reach out to the Hispanic/Latino community," stated Ossinalde. "Clinical trials can carry a stigma and my goal is to reform this belief by educating the general community that trial participation is critical to the mission of finding a cure for Alzheimer's," she added.
I recently read an article online that said astronauts may be exposed to radiation in space, which could later lead to their developing Alzheimer's Disease. Is this true?
Thank you for sending us your question. In the December 2012 issue of the scientific journal PLOS ONE, researchers from the University of Rochester in New York published findings from their NASA-funded study examining the impact of Galactic Cosmic Radiation on the brain. This research has generated substantial media attention.
The study aimed to discover the risks astronauts will be exposed to in space travel to distant locations, including Mars. In addition, the investigators wanted to learn whether exposure to Galactic Cosmic Radiation would speed up the progression of Alzheimer's disease (AD). The research team studied mice that carry human gene mutations that cause AD. At 3.5 months of age, all of the mice underwent memory testing to establish a baseline of cognitive functioning and were then exposed to radiation at dosages that would be experienced by astronauts on a mission to Mars. This was done at NASA's Space Radiation Lab at the Brookhaven National Laboratory. When examined 6 months later, AD mice exposed to Galactic Cosmic Radiation had greater cognitive impairment and more amyloid plaques, the hallmarks of AD, relative to unexposed animals.
You may be wondering how this research applies to those of us who are unlikely to venture into space. On earth, we are protected from harmful levels of radiation by our planet's atmosphere and magnetic field. So radiation is less of a concern than other risk factors for AD. The mice in the study also carried rare mutations that are not common in the general public, making it more difficult to extend the study results to the general population. Nevertheless, the results do suggest that the environment can impact the events to which we are genetically predisposed. We recommend trying to live as healthy a lifestyle as possible. This includes eating right, exercising, protecting your head (brain) from injury, maintaining an appropriate body weight and composition, being cognitively and socially active… and of course avoiding deep space travel.
Maryam Beigi, M.D.
Clinical Physician of Neurology
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We look forward to hearing from you!
Mary S. Easton Center Walks to End Alzheimer's
By: Melissa Bailey
Each year, the Alzheimer's Association California Southland Chapter hosts the Walk to End Alzheimer's in Century City. The Easton Center was proud to support the Walk this year and join in on the efforts to spread awareness. The Center saw a large turnout of staff, family, and four-legged friends. Team members met and offered information to those whose lives have been touched by this debilitating disease. "This is my favorite part of the job," said Doug Hawkins, the Easton Center's Triage Coordinator, "making that connection with someone who is in need of support, looking for answers and the best way to care for a loved one is what makes my job worthwhile."
In addition, the Alzheimer's Association invited Easton Center faculty to participate in their "Ask the Researcher" booth. The booth gave walk attendees the opportunity to find out more about how far research has progressed, learn about the types of studies going on in Los Angeles and around the world, and gather information on clinical trials.
This was my 3rd year in attendance and 2nd year as the Chair of the Easton Center Walk Team. The walk has grown bigger and better with every passing year and brings more interest to the Easton Center. I am already excited for the next one!
Clinical Research Opportunities
If you would like to advance Alzheimer's disease research, please consider participating at the Easton Center. Below are two current trials. For a complete list of enrolling studies, visit our website at www.eastonad.ucla.edu.
Alzheimer's Disease NeuroImaging Initiative (ADNI):
Study of Brain Metabolic Effects of Axona®: