BALANCE-AAD-1 Study: A new oral treatment for agitation in Alzheimer's Disease
The BALANCE-AAD-1 study by Celgene (Bristol-Myers Squibb) is designed to evaluate whether BMS-986368, an investigational oral medication, can safely reduce agitation in people with Alzheimer's disease. Participation includes 8 weeks of treatment plus about 4 weeks of follow-up (about 12 weeks total).
Study highlights
Key information about the BALANCE-AAD-1 study
- 55 to 90 years old
- Alzheimer's Disease with agitation
- Study partner (friend or family) required
- Oral medication
- Greater Omaha + Greater Austin (TX)
Study goal and design
Testing a new oral medication to reduce agitation in Alzheimer's Disease
Agitation is one of the most difficult aspects of Alzheimer's disease — it can cause restlessness, emotional outbursts, or disruptive behaviors that are distressing for the person and demanding for study partners. Effective treatments for agitation in Alzheimer's remain limited.
This study, sponsored by Celgene (Bristol-Myers Squibb), is evaluating BMS-986368 — a new once-daily oral medication — to assess whether it can safely and meaningfully reduce agitation. Approximately 120 participants are enrolled across sites in the United States. BMS-986368 is investigational and has not been approved by the FDA.
Study-related care and support
All study visits, assessments, and medication are provided at no cost
All study-related care is provided at no cost to participants. This includes:
- Daily oral study medication (BMS-986368 or placebo) provided by the study team
- Regular health monitoring — including vital signs, blood tests, and heart assessments
- Structured evaluations of mood and behavior at each study visit
- Study partner check-ins on daily functioning and quality of life
- Close oversight by qualified physicians and study nurses throughout
Before any commitment is made, the study team will walk you and your study partner through all aspects of participation — what each visit involves, how long it takes, and what to expect. You are free to ask questions at any time and may withdraw from the study at any point.
Volunteer journey
What to expect from your first contact to study completion
Express your interest
Complete a brief questionnaire about your age, Alzheimer's diagnosis, and whether you have been experiencing agitation or restlessness. A family member or study partner is welcome to assist.
Screening visit
The study team will invite you for a medical visit to confirm eligibility. This includes a review of your Alzheimer's diagnosis, a brief cognitive assessment, and an evaluation of your agitation symptoms. Your study partner must attend this visit with you.
Begin treatment
If eligible, you will receive a once-daily oral medication to take at home for 8 weeks. Some participants receive the active treatment; others receive a placebo (an inactive pill). Neither you, your study partner, nor the study doctor will know which — this ensures the results are reliable and unbiased.
Follow-up and completion
After the 8-week treatment period, you will have follow-up visits over approximately four weeks so the study team can monitor your health and confirm all is well. Once complete, your participation in the study is finished.
Ready to get involved?Join the BALANCE-AAD-1 study.
Contribute to progress, support research, help others, and care for your health.