CERE-110-03 (AAV-NGF)
Phase 2 Alzheimer's Clinical Trial
Summary
Study CERE-110-03 is a Phase 2 clinical trial of CERE-110 in patients with mild to moderate Alzheimer’s disease. This study is being conducted in collaboration with the Alzheimer's Disease Cooperative Study (ADCS).
This study will evaluate whether Ceregene's CERE-110 (AAV_NGF) is a safe and effective treatment for Alzheimer's Disease (AD). The study is being conducted at 11 sites throughout the United States.
Approximately fifty people with AD participated in this study. Half of the study subjects will undergo brain surgery to receive CERE-110, while the other half will undergo a similar surgery without receiving CERE-110 ("sham" or "mock" surgery).
Participants are carefully monitored by a team of study doctors and nurses for three years after the study surgery. There is no charge to participate in this study.
About CERE-110 (AAV-NGF)
CERE-110 is an experimental drug that contains the gene for nerve growth factor (NGF). NGF is a type of growth factor known as a neurotrophic factor that can help nerve cells survive and function better. CERE-110 uses a virus to deliver the NGF gene into the brain. CERE-110 has been shown to be safe in animals and in a previous small study in people with AD. CERE-110 has the potential to improve AD symptoms and possibly slow disease progression.
Why Use Gene Transfer?
Gene transfer, also known as gene therapy, is an efficient way to accurately deliver NGF directly into the specific areas of the brain where cells are damaged in AD patients. NGF cannot be taken by mouth or given via an injection because it will not travel to the brain and can cause unacceptable side effects.
Adeno-associated virus (AAV), the viral vector used in CERE-110, is a good carrier for this gene because it is able to enter brain cells and program these cells to make NGF. It does not multiply or travel to other parts of the body. Once the AAV enters a brain cell, the outside part of the virus degrades and all that remains is the gene that produces NGF.
Can The Viral Vector In CERE-110 Make People Sick?
The viral vector used in CERE-110 (AAV) is not known to cause disease in humans. However, there is always a risk of side effects.
Why Participate In a Clinical Trial?
New or improved AD treatments will only become available if patients are willing to volunteer to participate in clinical studies. The only way to properly test the effects of experimental drugs like CERE-110 is through a clinical trial.
This Study is No Longer Enrolling Patients
List of Participating Centers
ALABAMA
University of Alabama, Birmingham
Contact: Denise Ledlow
Phone: (205) 934-6223
Email: pdledlow@uab.edu
Birmingham, AL, United States, 35294
Principal Investigator: Ray L. Watts, M.D.
ARIZONA
Sun Health Research Institute
Contact: Karen Kohl
Phone: (623) 875-6512
Email: karen.kohl@bannerhealth.com
Sun City, AZ, United States, 85351
Principal Investigator: Marwan Sabbagh, M.D.
CALIFORNIA
University of California, Los Angeles
Contact: Joanna Quach
Phone: (650) 724-8278
Email: jquach@mednet.ucla.ed
Los Angeles, CA United States, 90095
Principal Investigator: Joshua D. Grill, Ph.D.
University of California, San Diego
Contact: Mary M. Pay
Phone: (858) 622-5804 ext 1804
Email: mpay@ucsd.edu
San Diego, CA, United States, 92037
Principal Investigator: Michael Rafii, M.D., Ph.D.
DISTRICT OF COLUMBIA
Georgetown University
Contact: Kelly Behan
Phone: (202) 728-6982
Email: keb53@georgetown.edu
Washington, DC, United States, 20007
Principal Investigator: R. Scott Turner, M.D., Ph.D.
GEORGIA
Emory University
Contact: Becky McMurray
Phone: (404) 728-6427
Email: rmcmurr@emory.edu
Atlanta, GA, United States, 30325
Principal Investigator: James J Lah, M.D., Ph.D.
NEW YORK
Mount Sinai School of Medicine
Contact: Priyanka Ghosh
Phone: (212) 659-8885
Email: priyanka.ghosh@mssm.edu
New York, NY United States, 10029
Principal Investigator: Judith A. Neugroschl, M.D.
NORTH CAROLINA
Duke University
Contact: Debra Heydt
Phone: (919) 668-2843
Email: debra.heydt@duke.edu
Durham, NC, United States, 27710
Principal Investigator: James R. Burke, M.D., Ph.D.
OHIO
Case Western Reserve University
Contact: Leon Hudson
Phone: (216) 464-6474
Email: leon.hudson@case.edu
Cleveland, OH, United States, 44120
Principal Investigator: Alan J. Lerner, M.D.
SOUTH CAROLINA
Medical University of South Carolina
Contact: Beth Safrit
Phone: (843) 740-1592 x38
Email: safritm@musc.edu
North Charleston, SC, United States, 29406
Principal Investigator: Jacobo E. Mintzer, M.D.
UTAH
University of Utah
Contact: Cam Torres
Phone: (801) 587-8385
Email: cam.torres@hsc.utah.edu
Salt Lake City, UT, United States, 84108
Principal Investigator: Edward Zamrini, M.D.