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

a study on Agitation Alzheimer's Disease

Summary

Eligibility
for people ages 55-90 (full criteria)
Location
at UCSD
Dates
study started
study ends around

Description

Summary

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.

Official Title

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)

Keywords

Agitation, Alzheimer Disease, Psychomotor Agitation, BMS-986368

Eligibility

You can join if…

Open to people ages 55-90

  • 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 < 21
  • 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.

You CAN'T join if...

  • 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.

Locations

  • University of California San Diego - La Jolla accepting new patients
    La Jolla 5363943 California 5332921 92037 United States
  • Kaizen Brain Center accepting new patients
    La Jolla 5363943 California 5332921 92037 United States
  • Accellacare - Sherman Oaks accepting new patients
    Sherman Oaks 5395244 California 5332921 91403 United States
  • Local Institution - 0017 not yet accepting patients
    Anaheim 5323810 California 5332921 92805 United States
  • Alliance Clinical -West Hills accepting new patients
    West Hills 8030162 California 5332921 91307 United States
  • Shreenath Clinical Service - Lakewood accepting new patients
    Lakewood 5364855 California 5332921 90805 United States
  • Inland Psychiatric Medical Group - Chino accepting new patients
    Chino 5336537 California 5332921 91709 United States
  • Next Level Clinical Trials accepting new patients
    West Covina 5407933 California 5332921 91790 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Celgene
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting
ID
NCT06808984
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 120 study participants
Last Updated
Contact us about this trial