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Alzheimer's Disease Study

Principal Investigator: William C. Fuller, MD

Study Coordinator: Christi Hinker, RNC

Sub-Investigators: Manish Sheth, MD; Matthew Malone, DO; Grace A. LaFollette, APRN, BC; Susan E. Weaver, CNP; Julie M. Kittelsrud, CNP

Study Description: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Efficacy and Safety Trial of Bapineuzumab (AAB-001, ELN115727) in Patients with Mild to Moderate Alzheimer's Disease

Overview: The purpose of this clinical drug study is to demonstrate the safety and effectiveness of an investigational drug in treating individuals with mild to moderate Alzheimer’s Disease. Qualified participants will be randomly assigned to receive either the investigational medication or placebo.

Participants in this study will receive the following, at no cost: study-related drug, physical examinations, laboratory tests, EKGs, and MRI scans. Individuals in this study may also be able to participate in some additional sub-studies. These include sub-studies on blood levels, changes in brain size or brain metabolism and function. Participants may volunteer for any, all or none of the sub-studies.

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Inclusion Criteria:

  • Men and women, age 50-88
  • Diagnosis of probable Alzheimer’s Disease, according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer’s Disease and Related Disorders Association
  • Either lives at home with an appropriate caregiver capable of accompanying the patient to all clinic visits or is in community-dwelling with a caregiver capable of accompanying the patient on all clinic visits and visiting with the patient approximately 5 times per week for the duration of the study

Exclusion Criteria:

  • Significant neurological disease, other than AD, that may affect cognitive ability
  • Current presence of a clinically significant major psychiatric disorder or symptom that could affect the patient’s ability to complete the study
  • Clinically significant abnormality on physical, neurological, laboratory, vital signs or EKG examination that could compromise the study or be detrimental to the patient

Contact: Christi Hinker, RNC
Phone: (605) 322-3084
Email: christi.hinker@mckennan.org

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