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CERE-110 in Subjects with Mild to Moderate Alzheimer's Disease

Active, not recruiting

The purpose of this study is to evaluate the potential benefits of CERE-110, an experimental drug, in the treatment of Alzheimer's disease (AD).

Minimum Age Maximum Age Gender Healthy Volunteers
55 Years 80 Years Both No
September 2009
December 2014
50

++Males and females 55-80 years old++MMSE score between 17 and 26++Modified Hachinski score less than or equal to 4++Stable doses of approved AD meds for 3 months prior to screening allowed; must remain stable for at least the first year after administration of CERE-110++Stable dose of Vitamin E not to exceed 1000 mg twice a day for 3 months prior to screening allowed; must remain stable for at least the first year after administration of CERE-110++Availability of study partner (10 hrs./week contact; participate in all visits)++Able to understand and comply with visit schedule and study procedures++Physically and mentally capable of performing required assessments++Medically able to undergo neurosurgery++Brain MRI at baseline without evidence of infection, infarction, or other focal (e.g., subdural hematomas, tumor, etc.) or generalized lesions (e.g., normal pressure or obstructive hydrocephalus, widespread infarcts, etc.)

++Significant neurological disease other than AD++Depression, major psychiatric disorder, psychotic features, behavioral problems++Alcohol or substance abuse within past 2 years++Systemic cancer within past 3 years++Aphasia that could interfere with neuropsychometric testing++Any significant systemic illness or unstable medical condition

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 participants 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 2 years after surgery.

Name City State Zip Status Primary Contact
University of Alabama
Birmingham Alabama 35294

University of California, Los Angeles
Los Angeles California 90095

University of California, San Diego
San Diego California 92037

Georgetown University
Washington District of Columbia 20007

Emory University
Atlanta Georgia 30325

Mount Sinai School of Medicine
New York New York 10029

Duke University
Durham North Carolina 27710

Case Western Reserve University
Cleveland Ohio 44120

Medical University of South Carolina
North Charleston South Carolina 29406

University of Utah
Salt Lake City Utah 84108

Ceregene

  • Alzheimer's Disease Cooperative Study (ADCS)

Name Role Affiliation
Paul S. Aisen, M.D. Study Director Alzheimer's Disease Cooperative Study (ADCS)

Name Phone Email
Sarah Walter, M.P.H. 858-622-5863 swalter@ucsd.edu

NCT00876863

Randomized, Controlled Study Evaluating CERE-110 in Subjects with Mild to Moderate Alzheimer's Disease