The purpose of this study is to evaluate the potential benefits of CERE-110 in the treatment of Alzheimer's disease. CERE-110 is an experimental drug that is designed to help nerve cells in the brain function better. CERE-110 uses a virus to transfer a gene that makes Nerve Growth Factor (NGF), a protein that may make nerve cells in the brain healthier and protect them from dying. The virus used in CERE-110 does not cause disease in people. CERE-110 has been carefully studied in laboratory animals and is in the early stages of being tested in people. Fifty patients with mild to moderate Alzheimer's disease will participate in this study. Half of the study subjects will have CERE-110 injected into the brain during a surgical procedure, while the other half will undergo a "placebo" surgery where no medication will be injected. All study participants will be followed for at least two years after surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
49
Injecting CERE-110 2.0 X 10\^11 vg into brain during surgical procedure.
Placebo Surgery
University of Alabama
Birmingham, Alabama, United States
University of California, Los Angeles
Los Angeles, California, United States
University of California, San Diego
San Diego, California, United States
Georgetown University
Washington D.C., District of Columbia, United States
Emory University
Atlanta, Georgia, United States
Mount Sinai School of Medicine
New York, New York, United States
Duke University
Durham, North Carolina, United States
Case Western Reserve University
Cleveland, Ohio, United States
Medical University of South Carolina
North Charleston, South Carolina, United States
University of Utah
Salt Lake City, Utah, United States
Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)
Time frame: 24 Months
Neuropsychological Test Battery
Time frame: 24 Months
Mini-Mental State Examination (MMSE)
Time frame: 24 Months
Neuropsychiatric Inventory (NPI)
Time frame: 24 Months
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
Time frame: 24 Months
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