About the ACCORD Study

The ACCORD study is underway to learn more about a medication for people living with dementia from Alzheimer's or who are taking medications for Alzheimer’s disease.

If someone you provide care for has Alzheimer’s and is not acting like themselves because of restlessness, aggression or irritability, this study may be an option.

What is “agitation associated with Alzheimer’s disease?”

In addition to cognitive decline, people with Alzheimer’s Disease typically have symptoms of restlessness, aggression or irritability. These symptoms are seen in a high percentage of people with the disease, with agitation being reported in approximately 70% of people with Alzheimer’s disease. By 2050, the estimated number of people in the United States living with Alzheimer’s will be 14 million.1
Agitation can be emotional distress, aggressive behaviors, disruptive irritability, and lack of inhibition. Agitation in people with Alzheimer’s disease has also been linked to increased caregiver burden, decreased functioning, earlier nursing home placement, and increased mortality risk.2

What do restlessness, aggression and irritability look like?
These symptoms may include:

Excessive Motor Activity

  • Pacing
  • Rocking
  • Pointing fingers
  • Repeating some behaviors
  • Gesturing

Verbal Aggression

  • Yelling
  • Screaming
  • Shouting

Physical Aggression

  • Shoving/Hitting/Hurting Self or Others
  • Grabbing onto People or Things
  • Biting
  • Destroying property
  • Throwing or Kicking Things
This is not a complete list. Some symptoms of restlessness, aggression or irritability may be difficult to recognize.

 

Why should someone participate in the study?

Someone you know or provide care for may receive some of these benefits from taking part in the study:

  • Care provided by board-certified physicians
  • Frequent memory check-ups
  • Compensation for time and travel

Someone you know or provide care for may also benefit others with agitation symptoms by taking part and helping us learn more about the restlessness, aggression or irritability that comes with Alzheimer’s disease.

 

How long will the study last?

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 (their restlessness, aggression or irritability gets better) 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 other study is to see if the investigational medication helps participants’ symptoms of restlessness, aggression or irritability over a longer treatment time.

Refer a friend

Do you know someone living with dementia from Alzheimer’s who is restless, aggressive, or irritable? Do you know a caregiver of someone with Alzheimer’s who is having a hard time managing their care? They may be eligible to participate in the ACCORD study. Consider sharing information with them about how they can learn more.

See if You Pre-Qualify Now

Complete the following questionnaire to see if someone you know or are caring for is able to pre-qualify for the ACCORD study and get connected with a research site near you.