A Phase 2, Randomized, Double-blind, Three-Arm, Placebo-controlled, Multicenter Study Assessing the Efficacy, Safety and Tolerability of orally administered BMS-986368, a FAAH/MAGL Inhibitor, for the treatment of Agitation in Participants with Alzheimer's Disease (BALANCE-AAD-1)
A clinical study for the treatment of agitation in adults with Alzheimer's disease
Why this Research Matters
Agitation is one of the most common features of Alzheimer's disease, occurring in up to 76% of people. It can cause a person to become restless, engage in repetitive behaviors such as rocking, or even become verbally or physically aggressive, such as shouting, pushing, or resisting, in certain places or situations. Agitation can significantly impact the quality of life for both the person with the condition and their caregivers. If you or someone you know is experiencing agitation associated with Alzheimer's disease, the BALANCE-AAD-1 Study may interest you. Participation in the study lasts about 5.5 months with visits to the study site to receive the study drug and for health checks and tests. Participants will receive study-related drugs and have study-related visits and tests at no cost. You and your study partner may also be eligible for reimbursement of some costs for travel to study visits. Speak to the study staff for more information.
Who can Participate
The study is enrolling adults who: Are 55 to 90 years of age. Have Alzheimer’s disease. Have been experiencing agitation for at least 4 weeks. Additional criteria will apply. Participants must have a caregiver who is willing to attend study visits and help with certain study activities. Participants are eligible if they live in nursing homes, assisted living facilities, memory care facilities, or at home.
Study ID
Protocol Number: 25-2727
Meet the Team
Principal Investigator