Georgetown Study Opens for Those With Inherited Genetic Risk for Alzheimer’s Disease
WASHINGTON (March 28, 2016) — The Memory Disorders Program (new window) at Georgetown University Medical Center (new window) is seeking volunteers to participate in a study testing two agents to slow the onset and progression of Alzheimer’s disease. Cognitively normal individuals with a particular genetic risk of developing the disorder are being sought.
The multicenter clinical trial is designed to evaluate the benefit and safety of two agents — both designed to prevent the build-up of brain plaque linked to Alzheimer’s disease — in cognitively unimpaired individuals who have two copies of the APOE4 gene. Only two percent of the general population have two copies of the gene (one inherited from each parent), but 10-15 percent of Alzheimer’s patients have two APOE4 genes.
The study will last an average of five years, or until a patient progresses to mild cognitive impairment due to Alzheimer’s disease.
“This is the first major study aimed at the prevention of Alzheimer’s disease in patients who are genetically at risk, but have not developed memory issues, and that’s quite exciting,” says Georgetown’s principal investigator, R. Scott Turner, MD, PhD (new window), director of the Memory Disorders Program.
The phase 3 clinical trial is sponsored by the National Institute on Aging (part of the National Institutes of Health), the Alzheimer’s Association, Banner Alzheimer’s Institute, Amgen and Novartis Pharmaceuticals Corporation, which has developed the investigative agents known as CAD106 and CNP520.
These agents are designed to eliminate beta amyloid, the hallmark protein that builds up in the brains of people with Alzheimer’s disease. CAD106 is a vaccine that prompts the body to make its own anti-amyloid antibodies to eliminate beta amyloid. CNP520 is an oral agent designed to prevent production of beta amyloid.
Initially the participants will be assigned to a group receiving the CAD106 vaccine or to a group receiving placebo. A second drug, CNP520 will be added to the group receiving the study vaccine in a few years. As other hopeful prevention drugs roll out, these will be included as additional groups within the study. In this process, known as randomization, participants cannot choose which group to join. The study will also be “blinded” — neither individuals nor researchers will know which group participants belong to until the end of the study.
Previous testing with both agents has shown promising results in halting the progressive dementia of Alzheimer’s disease, Turner says.
To enter the study, participants must be 60-75 years of age and have a study partner (family member or friend) who can accompany them on study visits. Participants must be cognitively normal and possess two APOE4 genes, which can be determined with a blood test. All subjects will undergo genetic counseling with a member of the study team.
Full study criteria are available at ClinicalTrials.gov.
To learn more about this or other clinical trials, please contact Carolyn Ward, program coordinator of the Memory Disorders Program at (202) 784-6671, firstname.lastname@example.org.
Turner reports the following disclosures: research support to Georgetown University from Lilly, Biogen, Toyama, AstraZeneca, Novartis and the National Institutes of Health.
About Georgetown University Medical Center
Georgetown University Medical Center (GUMC) is an internationally recognized academic health and science center with a four-part mission of research, teaching, service and patient care (through MedStar Health). GUMC’s mission is carried out with a strong emphasis on public service and a dedication to the Catholic, Jesuit principle of cura personalis — or “care of the whole person.” The Medical Center includes the School of Medicine and the School of Nursing & Health Studies, both nationally ranked; Georgetown Lombardi Comprehensive Cancer Center, designated as a comprehensive cancer center by the National Cancer Institute; and the Biomedical Graduate Research Organization, which accounts for the majority of externally funded research at GUMC including a Clinical and Translational Science Award from the National Institutes of Health. Connect with GUMC on Facebook (Facebook.com/GUMCUpdate) and Twitter (@gumedcenter). Connect with Georgetown University School of Medicine on Facebook (Facebook.com/somgeorgetown), Twitter (@gumedicine) and Instagram (@GeorgetownMedicine).