IMMEDIATE RELEASE: May 19, 2009
Georgetown Memory Disorders Program Offers Antibody Clinical Trial for Patients with Mild to Moderate Dementia due to Alzheimer’s Disease
Study is one of the first to allow treatment in patients’ homes
Washington, DC – The Memory Disorders Program at Georgetown University Medical Center is one of 38 centers nationwide offering a new, phase III clinical trial to examine the effects of an immunotherapy that targets amyloid beta (Aβ), a chief culprit in the development of Alzheimer’s disease.
“The purpose of the study is to see if a new kind of treatment can help reduce the rate of memory decline, and improve or prevent decline of daily functioning in patients with mild to moderate dementia due to Alzheimer’s disease,” says the study’s chief investigator, Scott Turner, MD, PhD, director of the Memory Disorders Program at GUMC.
The immunotherapy being studied in the clinical trial is called immune globulin (IG) and it is given intravenously (IV). IGIV is approved by the Food and Drug Administration and used successfully for more than 20 years to treat a variety of autoimmune and immunodeficiency diseases. It is not yet approved to treat Alzheimer’s disease.
“There is mounting evidence to support the use of this type of therapy to target the Aβ peptide in Alzheimer’s, but we won’t know if it truly works until we complete this clinical trial,” explains Turner. Two previous studies showed statistical improvement in cognition while reducing amyloid levels in the brain, thought to contribute to AD development.
“One of the attributes of this study is that most of the intravenous treatments can be administered in the comfort of the patient’s home – a novelty in clinical trials,” Turner says.
Participants will be treated intravenously every two weeks for 18 months. The first three infusions will occur at the General Clinical Research Center, located at Georgetown University Hospital. If the infusions are well-tolerated, the rest of the infusions may be done by a healthcare professional at the participant’s home (or other appropriate location). Visits to Georgetown still will be necessary during the course of the clinical study to conduct testing and examinations.
The study will last a maximum of 82 weeks. Two-thirds of participants will receive IGIV and one-third will get a placebo (inactive agent, not the study agent). Male and female study volunteers must:
- be 50-89 years old;
- be diagnosed with mild to moderate dementia due to Alzheimer’s disease;
- have a study partner (spouse, child, sibling or friend) in contact with the participant at least 10 hours a week who can accompany the participant for visits to Georgetown;
- have good venous access for repeated infusion and blood draws;
- be fluent in English; and
- be in generally good health.
This study is a phase III, double-blind, placebo-controlled study, called GAP (Gammaglobulin Alzheimer’s Partnership). Phase III means the investigational agent (IG) and its delivery (IV) has been studied in at least two earlier stages to assess safety and tolerability. Placebo–controlled means patients will be selected randomly to either receive the IG or an inactive substance so the agent can be assessed objectively. Adding to the study’s objectivity is that neither the doctor nor the patient will know if the study participant is receiving the active agent (double-blinded) until the end of the trial. About 360 people nationwide will participate.
The Memory Disorders Program is conducting several clinical studies for people with Alzheimer’s disease. Depending on the person’s medical status, he or she may qualify for other studies.
To learn how to participate in the study, contact Georgetown’s Memory Disorders Program at 202-784-6671 or visit the website at http://memory.georgetown.edu.
This study is being sponsored by the Alzheimer’s Disease Cooperative Study (ADCS) through a grant from the National Institute on Aging, and Baxter Healthcare Corporation (Baxter), maker of the active agent used in this study. The results of the study will be submitted to the FDA by Baxter. Georgetown University is being paid by the ADCS and Baxter to conduct this study. Turner, the study’s lead investigator at Georgetown, has no financial interests to disclose
About Georgetown University Medical Center
Georgetown University Medical Center is an internationally recognized academic medical center with a three-part mission of research, teaching and patient care (through Georgetown’s affiliation with 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 and Health Studies, both nationally ranked, the world-renowned Lombardi Comprehensive Cancer Center and the Biomedical Graduate Research Organization (BGRO), home to 60 percent of the university’s sponsored research funding.