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Recruiting NCT06808984

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

Phase II Interventional Agitation Alzheimer Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BMS-986368, Placebo.
Who it may be relevant to
Registry conditions: Agitation, Alzheimer Disease. Basic parameters: 55 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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.

Interventions

  • Drug BMS-986368
    Specified dose on specified days
  • Drug Placebo
    Specified dose on specified days

Primary outcome measures

  • Change in Cohen-Mansfield Agitation Inventory (CMAI) total score from baseline [Time frame: Up to Week 8]
Secondary outcome measures (12)
  • Change in Clinical Global Impression-Severity (CGI-S) [Time frame: Up to Week 8]
  • Change in CMAI-International Psychogeriatric Association (CMAI-IPA) Total Score [Time frame: Up to Week 8]
  • CMAI sub-score change in Aggressive Behaviors [Time frame: Up to Week 8]
  • CMAI sub-score change in Physically Non-aggressive Behaviors [Time frame: Up to Week 8]
  • CMAI sub-score change in Verbally Agitated Behaviors [Time frame: Up to Week 8]
  • Change in Neuropsychiatric Inventory Nursing Home Version (NPI-NH) Total Score [Time frame: Up to Week 8]
  • Change in NPI-NH Agitation/Aggression Domain Score [Time frame: Up to Week 8]
  • Change in NPI-NH Occupational Disruptiveness for Agitation/aggression Domain [Time frame: Up to Week 8]
  • Number of Participants with Treatment-Emergent Adverse Events (TEAEs) [Time frame: Up to Day 28 After Last Dose]
  • Number of Participants with Serious Adverse Events (SAEs) [Time frame: Up to Day 28 After Last Dose]
  • Number of Participants with Adverse Events (AEs) [Time frame: Up to Day 28 After Last Dose]
  • Number of Participants with Clinically Significant Laboratory Abnormalities [Time frame: Up to 28 Days After Last Dose]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 53 centers
  • Local Institution - 0046 — Homewood
  • University of Alabama - Huntsville Regional Medical Campus — Huntsville
  • Local Institution - 0048 — Phoenix
  • Local Institution - 0040 — Scottsdale
  • Local Institution - 0017 — Anaheim
  • Inland Psychiatric Medical Group. — Chino
  • Kaizen Brain Center — La Jolla
  • University of California San Diego - La Jolla — La Jolla
  • … and 45 more centers

Identifiers

NCT: NCT06808984 · IM045-P06 · U1111-1313-8997

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗