Tests a new pill for agitation in people with Alzheimer's disease
Tests BMS-986368 pills against placebo for agitation in adults with Alzheimer's disease.
Plain-language title generated from the registry record
Registry title: Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants With Alzheimer's Disease
Key facts
- Where
- Buenos Aires, Ciudad Autónoma de Buenos Aires, Córdoba, Mar del Plata, Mendoza, and Santiago del Estero, ArgentinaSee the 7 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 55 and 90 years old?
Source: NCT06808984, who can take part
Where in Argentina
- Buenos AiresBuenos Aires, ArgentinaNot yet recruiting
- Ciudad Autónoma de Buenos AiresCiudad Autónoma de Buenos Aires, ArgentinaNot yet recruiting
- CórdobaCórdoba, ArgentinaNot yet recruiting
- CórdobaCórdoba, ArgentinaNot yet recruiting
- Mar del PlataMar del Plata, ArgentinaNot yet recruiting
- MendozaMendoza, ArgentinaNot yet recruiting
- Santiago del EsteroSantiago del Estero, ArgentinaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Celgene
- Trial code
- NCT06808984
- Record updated
- 6 October 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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: History of major depressive episode with psychotic features during the 12 months prior to Screening; History of bipolar disorder, schizophrenia, or schizoaffective disorder; History of delirium within 30 days of Screening; Clinically significant delusions/hallucinations requiring hospitalization; Other protocol-defined Inclusion/Exclusion criteria apply.