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Phase III Alzheimer's Disease Clinical Trial Results Announced
By: Joshua Grill, Ph.D.
Late this summer, the initial results of a series of large Phase III clinical trials of investigational agents in development for Alzheimer's disease (AD) were announced. Four studies of two investigational drugs concluded their initial analyses and found no benefit of either drug. The two drugs, bapineuzumab and solanezumab, are both antibodies against the protein that builds up in the brains of persons with AD. The hope in these studies was that treatment would slow accumulation or reduce the total amount of the protein in the brain, and that this would slow progression of the decline that occurs in AD.
Unfortunately, for each of the four studies, this did not turn out to be case. None of the studies found that the treatment could slow cognitive or functional decline in patients who received the treatment, relative to persons who were randomly assigned to get a placebo (inactive drug).
Though Alzheimer's researchers, advocates, patients, and families were hoping for success in these studies, what is most important is that researchers learn from them. And we will.
These trials provide substantial and potentially pivotal information in the fight against AD. They enrolled thousands of participants and collected a wide array of biomarkers (biological measures of what happens in the brain and bodily fluids of persons with AD). These data will provide invaluable information and represent a step toward our ultimate goal of improved therapies for people with Alzheimer’s disease.
Importantly, this step could not have been taken without the thousands of Alzheimer's patients and family members who participated. The Easton Center's faculty and staff send our heartfelt appreciation to the participants in these studies who enrolled at UCLA and nation- and world-wide. Clinical trials that take the next steps toward improved treatments are ongoing and always need more participants.
2012 Spanish Thank You Luncheon
On Saturday, August 25th, the Easton Center said, "Gracias" to our Spanish-speaking research participants. A luncheon was held at the Olive View Medical Center, where the Easton Center enrolls research participants from the San Fernando Valley. This site features a research team including Drs. Shelly Wolf and Freddy Ortiz, and Norma Guerra (research coordinator). Each year, this luncheon is held in appreciation of those who participate in the Center's Longitudinal study. The luncheon was well attended by research participants and their families. The Alzheimer's Association, and other community resources had information tables at the event, providing attendees with resources and literature about Alzheimer's disease. The next Spanish Thank You luncheon will be held in Summer 2013.
I recently learned that the FDA has approved a bigger Exelon patch. Should I ask my doctor to prescribe this for my mom, who is currently on the previously recommended dosage?
Thank you for sending your question. The new larger patch was approved because its safety and efficacy was demonstrated in a clinical trial. Prior to the OPTIMA (Optimizing Transdermal Exelon in Mild-to-moderate Alzheimer's disease) study, the Exelon patch®(also known as rivastigmine) was approved by the Federal Drug Administration (FDA) at dosages of either 4.6 or 9.5 mg per 24 hours. The new maximum dosage that is FDA approved for treatment of mild to moderate Alzheimer's disease (AD) is 13.3 mg over 24 hours.
OPTIMA was a 72- to 96-week clinical trial in which 1584 mild to moderate Alzheimer's patients were given the original FDA approved dosage of 9.5 mg/24 h for 24- to 48-weeks. Those who were able to tolerate the 9.5 mg/24 h dosage were then randomized into a 1:1 double blind phase (neither the participant nor the research staff knew whether participant was receiving the new, higher dose or were kept at the standard dose). This phase lasted 48 weeks. To be selected for the double blind phase of the study, participants had to show cognitive and functional decline during the first phase of the study. In total 567 people showed decline; 280 were assigned to the 13.3 mg/24 h group and 287 remained at the 9.5 mg/24 h dosage. The higher dose did not show an increase in side effects, except slightly more participants in the 13.3 mg/24 h dose experienced a decrease in weight. Researchers found that, while both groups showed functional and cognitive decline, the group that received the higher dosage declined less (Cummings et al, 2012). For more detailed information about this study, please click here.
Exelon is a cholinesterase inhibitor. Medications in this category prevent the breakdown of acetylcholine, which is a brain chemical important in learning and memory. Other medicines in this class include donepezil (Aricept®) and galantamine (Razadyne®). Exelon is the only AD medication that is available in patch form.
The higher dose of Exelon has been FDA approved. Before switching to the higher dose, patients and their families should discuss it at length with the physician who treats their memory problems. Other considerations, such as tolerability and effectiveness of the current dose, are important before making changes.
Sarah Kremen, M.D.
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Support Group at the Easton Center
Caring for a loved one with dementia can be difficult and stressful. The Easton Center, in collaboration with the Alzheimer's Association, holds a support group for caregivers of patients with dementia. The group convenes the first and third Wednesday of each month from 1 pm – 2:30 pm at the Easton Center (10911 Weyburn Ave, 2nd Floor, Los Angeles, CA 90095). If you, or someone you know would like to join this group, please call (310) 794-6039 for more information.
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®: