Alzheimer's Dementia with Agitation - Tampa FL

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.