SIU School of Medicine

Jump directly to a section:

A 36-Week Safety Extension Study of Oral ELND005 for Treatment of Agitation and Aggression in Patients with Moderate to Severe Alzheimer's Disease

IRB Number

13-741

ClinicalTrials.gov Identifier

NCT01766336

Trial Status

Open for Enrollment
Phase 2

Why is this study being done?

The purpose of this study is to determine whether ELND005 is safe and effective in reducing symptoms of agitation and aggression in people with moderate to severe Alzheimer's Disease(AD). This study is being done and funded by a company (Elan Pharma International Ltd) that does drug research studies (called a “sponsor”). People with AD often experience agitation and aggression, this study is to determine if ELND005 will reduce the severity. Currently, treatments for agitation and aggression in people with AD are not always effective and may have side effects.

Who is eligible to participate?

Patients who have been diagnosed with moderate to severe Alzheimer's Disease and are experiencing some symptoms of agitation and aggression.

What is involved?

All study subjects will receive ELND005 (active study drug) during the 36 weeks of this study, but the dose will depend on which study group you were assigned to during the ELND005-AG201 study. Each study subject will be given either ELND005 or a combination of ELND005 and placebo. A placebo looks the same as ELND005 but has no active drug ingredients in it (like a sugar pill).If you agree to participate in this research study, you will be asked to make a approximately 8 visits to the study clinic. You will have an additional six telephone visits. You may also need to make additional visits to another facility for additional tests. Your participation in the study will be up to 42 weeks (approximately 9.5 months) and will consist of two periods: a Dosing Period (36 weeks) and a Follow-Up Period (six weeks). Depending on the required procedures and assessments, your visits may take up to two hours.

How long is the study?

Approximately 9.5 months

Who can I contact for additional information?

Barbara Cray Lokaitis 217-545-9737

Who is the Principal Investigator of this study?

Tom Ala, MD

Where is the trial located?

Springfield, Illinois