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A Prospective, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Efficacy and Safety Study of Oral ELND005 for Treatment of Agitation and Aggression in Patients with Moderate to Severe Alzheimer's Disease

IRB Number

13-682

ClinicalTrials.gov Identifier

NCT01735630

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 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 and it is hoped that 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 (AD) and are experiencing some symptoms of agitation and aggression.

What is involved?

Patients are randomized into one of two groups (study drug or placebo). If you agree to participate in this research study, you will be asked to make a total of seven visits to the study clinic. You will have an additional four 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 22 weeks (approximately 5.5 months) and will consist of three periods: a Screening Period (up to four weeks), a Dosing Period (12 weeks), and a Follow-Up Period (six weeks). If you are eligible and willing to participate in the extension study (the AG251 study), you can begin the extension study at the last visit of this study’s dosing period (after completing 12 weeks of dosing) instead of entering the six week Follow-Up period. Depending on the required procedures and assessments, your visits may take up to two hours. However, because of the need to do blood tests a minimum of three hours apart, your baseline visit will take approximately four hours. If you have questions about the time commitment for each visit, Dr. Ala or his study staff can provide you with additional information. Eligible study subjects will be able to enter the 36 week extension study after completion of the 12 week Dosing Period. No other plans are currently in place to provide study subjects with study drug following conclusion of this study. At each clinic visit during the study, except for Visit 4, you will be evaluated with test scales that assess your memory and thinking skills as well as mental and emotional state. Dr. Ala or his study staff may complete some test scales using a tablet computer, similar to an iPad®. Typing will not be required for the scales you are completing.

How long is the study?

Approximately 5.5 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