This study is testing the safety of injecting a growth factor gene into the brains of people with AD. CERE-110 is a gene transfer drug that has been studied by scientists in laboratory animals and is in its earliest stage of testing in people.
Gene transfer is sometimes called gene therapy; it is a medical technique that involves adding genes to cells so that the body can make a protein to fix a disease.
CERE-110 is an experimental drug that is designed to tell brain cells to produce more of a protein substance that helps nerve cells grow.
Criteria
diagnosis of mild to moderate AD
reliable study partner
stable health
Study Procedures
25 months
2 visits prior to the surgery
8 visits after the surgery
each visit lasts 2-4 hrs.
MRI scans
PET scans
memory testing
blood draws
2-day inpatient surgery
annual visits at culmination of the 25 month study period
The Home Based Assessment will evaluate three in-home types of information gathering and determine how practical each method is. Second, it will find out if these three methods of gathering information can detect a change and a rate of change in both the volunteers’ daily living activities and their functional capabilities over time.
Criteria
normal mental function
aged 75 and older
able to live independently
fluent in English
willing to take multi-vitamins provided by the study
able to dial a telephone, have access to secure mail, possess minimal computer skills or a willingness to learn
Study Procedures
4 years
in-person screening assessment that includes a physical exam, a medical history, a memory assessment, and a neurological exam
blood sample
random assignment to one of three information gathering methods: Mail/Phone, telephone, Interactive Voice Response, or Electronic Kiosk
completion of experimental assessments via their assigned method at specified monthly, quarterly, or annual intervals
Basic research studies found that blocking the interaction of amyloid beta protein and a receptor called Receptor for Advanced Glycation Endproducts (RAGE) led to a decrease in amyloid deposits. In this study, researchers will test whether a novel drug that acts as a RAGE Inhibitor (RI) slows the progression of Alzheimer's disease as well as behavioral problems that may occur.
Criteria
age 50 or older
have mild to moderate AD (MMSE 14-26)
have not suffered from serious/unstable disease within the past three months
are not diabetic
are able to see and hear well
are able to read and write in the language in which the tests are presented
have a reliable caregiver
are willing and able to participate in the 22-month study
