For Providers

A clinical research study is enrolling now

For people that are living with dementia from Alzheimer’s or are taking medications for Alzheimer’s disease.

More than 5 million individuals in the United States are living with Alzheimer’s disease. This is estimated to increase to approximately 15 million by 2050.

Up to 70% of patients experience symptoms of restlessness, aggression, or irritability (emotional distress, aggressive or disruptive behaviors, shouting and disinhibition). The symptoms increase caregiver burden, decrease patient functioning, and can result in earlier nursing home placement and increased mortality risk.

 

RESTLESSNESS, AGGRESSION AND IRRITABILITY IN PATIENTS LIVING WITH DEMENTIA FROM ALZHEIMER’S REMAINS A CHALLENGE WITH NO APPROVED THERAPIES. THE ACCORD STUDY IS INVESTIGATING A POTENTIAL TREATMENT.

About the Study

The ACCORD Study is a double-blind, placebo-controlled randomized withdrawal trial to assess the efficacy and safety of AXS-05 for the treatment of agitation (restlessness, aggression, or irritability) in subjects with dementia of the Alzheimer’s type.

STUDY DESIGN:

Treatment Period: Up to 35 weeks
Study_Design_Chart

KEY ELIGIBILITY CRITERIA:*

  • 65-90 years of age, inclusive
  • A probable diagnosis of Alzheimer’s (patients may be diagnosed during screening)
  • Symptoms of restlessness, irritability, or aggressive behaviors (this can be as mild as pacing or repeating themselves, or as challenging as physical aggression like punching and kicking)
  • A supportive, consistent, and reliable caregiver willing to participate
    * Other criteria apply.

Participation in this study could last up to 39 weeks, or almost 10 months. The study is divided into three parts:

  • Screening period (up to 4 weeks)
  • Period 1 (up to 9 weeks)
  • Period 2 (up to 26 weeks)

After a short screening period, participants who choose to take part in the ACCORD study will take an investigational medication (AXS-05, not placebo) for up to 9 weeks. If there is a treatment response, they can go into the next part of the study where they have an equal chance (50/50) of taking the investigational medication or a placebo for up to 26 weeks. Neither the participants nor the study doctor will know if they are taking the investigational medicine or a placebo.

After finishing the study, participants will have the option to join another study in which they will be given the investigational drug (AXS-05, not placebo) for up to 6 months. The purpose of this open label study is to see if the investigational medication helps participants’ symptoms of restlessness, aggression or irritability over a longer treatment time.

What is AXS-05?

 

AXS-05

Next steps

If you have a patient who may pre-qualify for this study, click here to fill out our contact form and connect with a nearby research site.

You can also click the button below to share this study with someone you know.