If you or someone you know is experiencing agitation related to Alzheimer’s disease, the ADAGIO-1 Study may interest you. Agitation is one of the most common features of Alzheimer’s disease, and it can cause a person to become restless, irritable, upset, or even aggressive. Agitation can significantly impact quality of life for both the person with the condition and their caregivers. The ADAGIO-1 Study is testing an oral study drug to see if it can safely treat agitation.
Eligibility Criteria
- Are 55 to 90 years of age
- Have been diagnosed with Alzheimer’s disease.
- Have been experiencing physical and/or verbal agitation (e.g., hitting, kicking, shouting, cursing, pacing, wandering, throwing things, resistance to care) for at least 2 weeks.
- Participants must have a caregiver or study partner join them at study visits and help with certain study activities. A caregiver may be a family member, friend, hired professional, or staff member (if the participant is living in a nursing home or memory care facility) who spends at least 10 hours a week with the participant.
There are also other requirements. Participants will need to attend a Screening Visit to see if they qualify.
What does the study involve?
- Number of contacts: 10+ sessions
- Format of Study: Hybrid (mix of in-person and virtual visits)
- Compensation offered: Yes
Investigator(s): Dr. Sanjeev Kumar
Full Study Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated with Alzheimer’s Disease (ADAGIO-1)
Contact Information:
E-mail: ADAGIO.Study@camh.ca
REB number: 111/2025
REB Approval Expiry Date: March 3, 2027
PLEASE NOTE:
- Research staff cannot give medical advice over the phone or via email.
- If you have specific questions regarding your health care, please contact your family physician.
- We regret that not everyone screened for a study will be eligible to participate
- For more information about other treatment options for mental illness or addiction offered by CAMH, visit www.camh.ca or call 416-535-8501.