RightFit
RecruitingPhase 2

Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants With Alzheimer's Disease

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
55 Years to 90 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests BMS-986368 for agitation in people with Alzheimer's disease. Agitation can include restlessness or aggressive behavior. The study looks at how well the drug works, its safety, and how well people tolerate it.

This is a study to evaluate the efficacy, safety, and tolerability of BMS-986368, a FAAH/MAGL inhibitor, for the treatment of agitation in participants with Alzheimer's Disease.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have Alzheimer's disease confirmed by tests for signs of the disease and meeting the 2024 Alzheimer's Association diagnosis rules.
  • Have agitation that meets the International Psychogeriatric Association's definition.
  • Agitation started at least 4 weeks before the screening visit.
  • Score 24 or lower on the MMSE-1, a test of memory and thinking.
  • Score 4 or higher on the agitation/aggression part of the NPI-NH behavior rating scale.
  • Have a stable living setting for at least 6 weeks before screening. You may live at home, in assisted living, or in a nursing home, and must have a caregiver as a study partner.
  • Can move around on your own, with or without help from a device. Wheelchairs and other mobility aids are allowed.

Who can't join

  • Have false beliefs or see or hear things that are not there, severe enough to need a hospital stay.
  • Have a history of bipolar disorder, schizophrenia, or schizoaffective disorder, which affect mood, thinking, or a person's sense of what is real.
  • Had major depression with false beliefs or seeing or hearing things that are not there in the 12 months before screening.
  • Had delirium, a sudden state of confusion, within 30 days before screening.
  • Other study rules may also affect who can join.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria * Participants with a diagnosis of Alzheimer's disease with biomarker confirmation meeting the 2024 Revised criteria for diagnosis and staging of AD: Alzheimer's Association Workgroup. * The diagnosis of agitation must meet the International Psychogeriatric Association (IPA) definition of agitation. * History of agitation with onset at least four weeks prior to Screening. * MMSE-1 score ≤24. * NPI-NH agitation/aggression sub-score ≥ 4. * Stable living environment for at least 6 weeks prior to Screening. Participants are eligible if they are in nursing homes, assisted living facilities, or living at home and have an identified study partner (caregiver). * Capable of self-locomotion (alone or with the aid of an assistive device); wheelchairs and other mobility aids are acceptable. Exclusion Criteria * Clinically significant delusions/hallucinations requiring hospitalization. * History of bipolar disorder, schizophrenia, or schizoaffective disorder. * History of major depressive episode with psychotic features during the 12 months prior to Screening. * History of delirium within 30 days of Screening. * Other protocol-defined Inclusion/Exclusion criteria apply.

Study sites (60)

AL

AZ

CA

CO

DC

FL

GA

HI

IL

LA

MA

MI

MT

NC

NE

NJ

NV

NY

OH

OK

PA

TN

TX

UT