About the ASPECT Study

Agitation associated with Alzheimer’s dementia can be difficult and unpredictable to manage, as well as very challenging for patients and their loved ones.

Examples of some easily identifiable agitated behaviours are:4

The purpose of the ASPECT study

Currently, there is no approved treatment in the US for agitation associated with Alzheimer’s dementia.

In this study, an investigational drug called AVP-786 will be compared with placebo in patients with agitation associated with Alzheimer’s dementia. Researchers want to find out if this investigational drug is safe and effective (useful) in managing agitation in patients with Alzheimer’s dementia.

4 Cummings J, et al. Agitation in cognitive disorders: International Psychogeriatric Association provisional consensus clinical and research definition. International Psychogeriatrics. 2015;27:7-17

What can study participants and their carers expect?

The study will last 20 weeks.

Eligible participants enrolled into this study will be randomly assigned (by chance, like drawing straws) into groups receiving either the investigational drug or placebo.

This study is blinded, which means that the participant, their carer, the research staff and even the study doctor will not know if the participant is receiving the investigational drug or placebo.

It is very important that both the participant and their carer attend all study visits and complete all study procedures.