Clinical Trial 45862

Tampa, FL 33613


Summary:

Agitation is a common and serious problem among people living with Alzheimer's dementia.  Examples of some easily identifiable agitated behaviors are:

Restlessness, Pacing, Aimless wandering, Shouting, Screaming, Throwing things, Resistiveness, Constant requests for help, Tearing things up, Kicking, Hitting others or self, and/or not allowing others to help.

In this study, researchers want to find out if an investigational drug called AVP-786 is safe and effective in managing agitation in adults with Alzheimer's dementia, when compared to a placebo.  Participants will be randomly assigned to receive either AVP-786 or a placebo.  

Study duration:

Screening period up to 28-days

A 12-week Treatment Period

A 30-day Follow-up period at the end of the study.

There are 10 in-clinic study visits.


Qualified Participants Must:

• Be between the ages of 50 and 90
• Have a diagnosis of probable Alzhemier's disease
• Have moderate to severe agitation that interferes with daily life
• Have a caregiver who spends a minimum of 2 hours per day, 4 days per week with them and is willing and able to comply with all study procedures
• Other criteria will be discussed upon contact


Qualified Participants May Receive:

The study drug and any study-related procedures and exams will be provided at no cost to participants.

There is also a small stipend which will be paid to partcipants to off-set time and travel to study visits.


Available At:

University of South Florida - Department of Psychiatry and Behavioral Neurosciences
3515 East Fletcher Avenue
USF Memory Disorder Clinic
Tampa, FL 33613
View Clinic Location

 


If you or someone you care for is interested in participating and lives within 50 miles of the location shown, please complete the form below and click 'Submit'

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.