It is well known that individuals with Down Syndrome (DS) develop Alzheimer’s at a much higher rate than the general population. This research study will test whether an investigational vaccine can affect Alzheimer’s-related brain changes in DS. The study is designed for individuals who meet the following criteria:

• Diagnosed with Down Syndrome

• Between the ages of 25 to 45

• Must not have any other serious illness

• Have a caregiver/informant who can answer questions about you

The study is a randomized, placebo-controlled, double-blinded study. This means that study participants will be randomly given either the active investigational vaccine or a non-active placebo that looks like the active drug; neither the participant nor the study personnel at the clinic will know who is receiving which one.

The study will last 24 months, during which study participants will visit the study clinic 21 times. At each visit, participants will be asked how they are feeling, and at some of the visits they will undergo medical exams, memory tests, blood tests, lumbar punctures (optional), ECG and brain imaging scans. The investigational vaccine and research visit procedures are free of charge. Travel costs will be paid.

Academic Medical Centers and Specialty Clinics Participating in the 3 Star Study

Barrow Neurological Institute	Phoenix, AZ	Sandy Quintanilla Study Coordinator Barrow Neurological Institute (602) 406-7054 Sandy.Quintanilla@DignityHealth.org
University of California, San Diego	San Diego, CA	Chris Slowik UCSD: Adult Down Syndrome Program (858) 249-2526 CSlowik@health.ucsd.edu
Massachusetts General Hospital	Boston, MA	Vasiliki Patsiogiannis Down Syndrome Program (617) 724-9086 VPatsiogiannis@mgh.harvard.edu