Alzheimer’s disease Research Study

If you care for someone who may have a diagnosis of Alzheimer’s disease and they have been experiencing symptoms of disruptive behavior which have made caring for them even more difficult, the ADVANCE-2 study may be an option.

TAKE THE NEXT STEP

If you care for someone who may have a diagnosis of Alzheimer’s disease and they have been experiencing symptoms of disruptive behavior which have made caring for them even more difficult, the ADVANCE-2 study may be an option.

This local Alzheimer’s disease research study is seeking people who are: *

    • Aged 65 to 90 years old
    • May have a diagnosis of Alzheimer’s disease
    • Currently exhibiting or showing signs of restlessness, aggression or irritability
    • Have a dedicated caregiver

*Additional eligibility criteria apply

If you think your family member may qualify, reach out to your local study center or visit our website to answer our questionnaire. All personal health information will be kept confidential.

WHAT DISRUPTIVE BEHAVIORS CAN ACCOMPANY ALZHEIMER’S DISEASE?

In addition to cognitive decline, people with Alzheimer’s disease typically experience behavioral and psychological symptoms including restlessness, irritability and aggression. These symptoms are seen in a high percentage of people with the disease, and are 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

These changes are characterized by emotional distress, aggressive behavior, disruptive irritability, and lack of inhibition. They have also been associated with increased caregiver burden, decreased functioning, earlier nursing home placement, and increased mortality risk.2

CARING FOR SOMEONE WITH ALZHEIMER’S DISEASE

Alzheimer’s disease can be difficult for caregivers and family members. More than 16 million Americans provide unpaid care for people living with Alzheimer’s disease and other dementias. Caregivers provide an estimated 18.6 billion hours of care each year.1 When these difficult behaviors arise, caregiving can become a heavy burden.

ABOUT THIS STUDY

Doctors at selected centers in the U.S. and Canada are seeking participants for the ADVANCE-2 study. This study is evaluating an oral investigational medication, AXS- 05 (dextromethorphan-bupropion), for the treatment of agitation associated with Alzheimer’s disease.

Qualified participants will receive study- related care at no cost, and thier overall health will be closely monitored by a study doctor. They may also be paid for their time and reimbursed for travel-related expenses.

ABOUT CLINICAL STUDIES

Clinical research participation is an important part of developing new treatments for conditions like Alzheimer’s disease or the symptoms associated with these diseases. You should feel fully informed about what to expect from participation in a clinical research study. In order to assess the safety and effectiveness of new investigational medications, research requires people like you to take the first step.

Participation in any clinical research study is completely voluntary, and you may withdraw from a clinical research study at any time for any reason. Before choosing to participate, it is important to weigh the risks and benefits of participation. If you have any questions about this study, contact your local study center.

HOW DO I RECOGNIZE THESE BEHAVIORS?

For some, recognizing disruptive behaviors may be difficult at first. Here are some example behaviors you may notice:

VERBAL BEHAVIORS

  • Cursing
  • Repetitive
  • Sentences/
  • Questions
  • Complaining

PHYSICAL BEHAVIORS

  • Intentional Falling
  • Spitting (including while feeding)
  • Restlessness,
  • Pacing, or Aimless Wandering

PHYSICAL AGGRESSION

  • Hitting/Hurting
  • Self or Others
  • Grabbing Onto
  • People or Things
  • Throwing or Kicking Things

This is not a complete list. If these behaviors remind you of situations that have affected a family member you provide care for, speak to your local study center and ask about the ADVANCE-2 study.

1. Alzheimer’s Association. 2020 Alzheimer’s disease facts and figures. Alzheimer’s Association website. http://alz.org/alzheimers-dementia/facts-figures2. Antonsdottir IM, Smith J, Keltz M, Porsteinsson AP. Advancements in the treatment of agitation in Alzheimer’s disease. Expert Opin Pharmacother. 2015;16(11):1649–1656. Rabins PV, Schwartz S, Black BS, et al. Predictors of progression to severe Alzheimer’s disease in an incidence sample. Alzheimers Dement. 2013;9(2):204–207.

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