Georgetown Seeks Volunteers for New Immunotherapy Clinical Trial for Alzheimer’s
WASHINGTON (Feb. 26, 2016) — The Memory Disorders Program at Georgetown University is seeking volunteers to participate in an international clinical trial of a drug that, in an early phase study, has demonstrated promise in slowing mental decline in Alzheimer’s disease. Georgetown is the only institution in the greater Washington, DC, area offering access to the phase 3 study of the investigational immunotherapy drug aducanumab.
The multicenter clinical trial is designed to evaluate the benefit and safety of the drug in patients with mild Alzheimer’s disease, says Georgetown’s principal investigator, R. Scott Turner, MD, PhD., who sees patients at MedStar Georgetown University Hospital.
“We are excited to offer this clinical trial to our patients. It is the only study to date that has shown some benefit in early Alzheimer’s disease, both in terms of symptom management and disease modification,” he says. “This advanced study is needed to confirm if and how well the drug works, and at what dose.”
The study is sponsored by Biogen Idec, which manufactures aducanumab, an immunotherapy designed to reduce beta amyloid plaque in the brain. Progressive accumulation of the protein is one of the hallmarks of Alzheimer’s disease.
In data presented at the Alzheimer’s Association International Conference in July, Biogen announced interim analysis of an early phase study that found a significant reduction of beta amyloid plaque build up in the brain. It also showed a slowing of clinical impairment in patients with mild disease who were treated for nearly a year with a monthly dose of aducanumab.
The only side effect of concern seen in previous studies was inflammation of the brain, found in a small fraction of patients, Turner says. “However, this was detected by brain imaging only — there were no symptoms — and was transient and reversible. During our study, participants will be carefully monitored by frequent examinations and brain MRI scans.”
The primary objective of the new study is to evaluate the efficacy of monthly doses of aducanumab in slowing cognitive and functional impairment in participants with mild Alzheimer’s disease as compared with a placebo. A high dose and low dose will be tested, and the drug is administered intravenously.
Some participants will be randomly assigned to a group that is given a low dose, or another group given a higher dose, or to a group given a placebo drug (a process known as randomization). The study will also be “blinded” — neither individuals nor researchers will know which group participants belong to.
To enter the study, patients must have evidence of beta amyloid accumulation (confirmed by a PET scan) and meet clinical criteria for mild Alzheimer’s disease. Participants must be between the ages of 50-85 and have a study partner who can accompany them to all appointments.
Full study criteria are available at ClinicalTrials.gov (new window).
To learn more about this or other clinical trials, please contact Carolyn Ward, program coordinator of the Memory Disorders Program at (202) 784-6671 or firstname.lastname@example.org.
Research support to Georgetown University has been provided by Eli Lilly and Co., Biogen, Toyama Chemical Co., AstraZeneca, Novartis and the National Institutes of Health.
About Georgetown University Medical Center
Georgetown University Medical Center (GUMC) is an internationally recognized academic medical center with a three-part mission of research, teaching 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 (UL1TR001409-01) from the National Institutes of Health.