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Clinical Trial Title: 
Study of Lu AE58054 in patients with Alzheimer’s disease treated with donepezil (STARSHINE Study)
Clinical Trial Protocol ID: 
Clinical Trial Investigator Name: 
Neelum Aggarwal, MD
Clinical Trial Protocol Description: 

The purpose of this seven-month study is to establish the efficacy and effect of multiple doses of an experimental drug compared to placebo as adjunctive therapy to donepezil in patients with Alzheimer’s disease.

Subjects will receive blinded study treatment taken once daily for study duration. Subjects will undergo cognitive testing and physical examinations, ECGs and blood draws throughout the course of the study. Clinic visits every 4-6 weeks will be conducted.

At Rush University Medical Center we expect to recruit approximately 10 patients. The treatment will be assigned randomly.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Be 50 years of age or older.
  • Have been diagnosed with Alzheimer’s disease.
  • Have been on a stable donepezil medication for more than six months, with a stable dose at 10mg/day ≥ four months.

You will be excluded from the study if any of the following criteria apply to you:

  • Have serious/unstable illnesses, or a history of drug or alcohol abuse/dependence within the past five years.
  • Have been taking AD treatment (e.g. Exelon, Namenda, Galantamine) except Aricept for the past six months.

This is a partial list of inclusion and exclusion criteria. 

Clinical Trial Area: 
Alzheimer’s Disease and Related Dementias
Contact Phone: 
(312) 942-2633
Contact Name: 
David Sedillo