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 ≤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.

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 California 92037 United States
  • Kaizen Brain Center accepting new patients
    La Jolla California 92037 United States
  • Accellacare - Sherman Oaks accepting new patients
    Sherman Oaks California 91403 United States
  • Local Institution - 0017 not yet accepting patients
    Anaheim California 92805 United States
  • Local Institution - 0028 completed
    West Hills California 91307 United States
  • Shreenath Clinical Service - Lakewood accepting new patients
    Lakewood California 90805 United States
  • Inland Psychiatric Medical Group. accepting new patients
    Chino California 91710 United States
  • Next Level Clinical Trials accepting new patients
    West Covina California 91790 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Celgene
ID
NCT06808984
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 120 study participants
Last Updated