Skip Navigation Links  

Multi-Center, Double-Blind, Placebo-Controlled Phase IIa Study to Evaluate an Investigational Medicine to Treat Early Alzheimer’s Disease.

What is the CONNECT Study?

The CONNECT study will test whether an oral, experimental drug, AZD0530 (saracatinib), will slow progression in mild-stage Alzheimer’s disease (AD). Although the cause of AD is unknown, several lines of evidence suggest that a peptide known as beta-amyloid plays a central role. Convergent evidence in recent years has yielded a refinement of the “amyloid hypothesis”, suggesting that neurotoxicity of beta-amyloid oligomers leads to Alzheimer’s disease. The protein Fyn kinase, a member of the Src family kinases, may play a fundamental role in the pathway by which beta-amyloid oligomers damage neurons. AZD0530 is a selective inhibitor of Src family kinases that was previously developed as a cancer therapy but may hold greater promise as a treatment for AD. CONNECT researchers will use PET imaging to evaluate whether the drug is effective in slowing decline in brain metabolism and will also determine whether it is safe and well tolerated in patients with AD.

In this study 152 participants will be randomly assigned to receive either an active dose of AZD0530 or a dose of an inactive drug called a placebo. Participants will have a 50/50 chance of receiving the active drug or placebo. Neither participants nor study personnel will know who is receiving the active drug and who is receiving the placebo. Screening will occur over six weeks followed by a 52-week treatment period. The study requires a minimum of four visits during the screening and 13 to 14 visits during the course of the treatment.

Who is eligible to participate?

  • Men or women aged 55-85 years
  • Have a diagnosis of mild Alzheimer’s disease
  • Are willing to undergo a variety of clinic assessments, including MRI and PET scans
  • Have a study partner willing to attend clinic visits who has at least 10 hours/week of contact with study participant
  • Cholinesterase inhibitors and memantine are allowed if the doses are stable for three months prior to screening

This study is being conducted by the Alzheimer’s Disease Cooperative Study (ADCS) and Yale University through a grant from the National Center for Advancing Translational Sciences (NCATS), one of the National Institutes of Health. Dr. Christopher H. van Dyck of Yale University is directing the study.

The CONNECT Study Locations

AZSun CityBanner Sun Health Research Institute   
CALos AngelesUniversity of California, Los AngelesCeline Ossinalde(310)
CAPalo AltoStanford University School of Medicine   
CTNew HavenYale University School of MedicineCarol Gunnoud(203)
DCWashingtonGeorgetown UniversityEmily Voeller(202)
FLMiami BeachWien Center for Clinical ResearchMaria Greig-Custo(305)674-2121 ext
FLMiami BeachWien Center for Clinical ResearchAna Betancourt(305)674-2121 ext
FLTampaUniversity of South Florida - Health Byrd Alzheimer InstituteHaitham Abulaban(813)
ILChicagoRush University Medical CenterDavid Sedillo(312)
ILChicagoNorthwestern UniversityKristine Lipowski(312)
INIndianapolisIndiana University   
KYLexingtonUniversity of KentuckySarah Tarrant(859)
KYLexingtonUniversity of KentuckyHeather Nichols(859)
MABostonBrigham and Women's Hospital   
MIAnn ArborUniversity of Michigan, Ann Arbor   
NYNew YorkColumbia UniversityRuth Tejeda(212)
NYRochesterUniversity of Rochester Medical CenterNancy Kowalski(585)
ORPortlandOregon Health & Science UniversityElisabeth Loree(503)
PAPittsburghUniversity of PittsburghMaryAnn Oakley(412)
SCCharlestonRoper St. Francis Hospital   
WASeattleUniversity of WashingtonAnita Ranta(206)