Qualifications for this Study

Inclusion Criteria:

• Males and females 55-80 years old
  
• MMSE 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, and must remain stable for at least the first year after administration of CERE-110
  
• Stable dose of Vitamin E not to exceed 1000mg twice a day for 3 months prior to screening allowed, and 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.)

Exclusion Criteria:

• 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

Prohibited Medications:

• Narcotics, methyldopa, or clonidine except where indicated for pain management in the immediate postoperative period
  
• Antiparkinsonian medications including levodopa/carbidopa, amantadine, bromocriptine, pergolide, selegiline
  
• Antipsychotics and neuroleptics prior to screening and dosing; may be prescribed during the course of the study if needed

Study Description

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 two years after surgery.

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