Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants With Alzheimer's Disease
NCT ID: NCT06808984
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
120 participants
INTERVENTIONAL
2025-06-09
2027-09-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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BMS-986368 Dose 1
BMS-986368
Specified dose on specified days
BMS-986368 Dose 2
BMS-986368
Specified dose on specified days
Placebo
Placebo
Specified dose on specified days
Interventions
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BMS-986368
Specified dose on specified days
Placebo
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
55 Years
90 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0046
Homewood, Alabama, United States
University of Alabama - Huntsville Regional Medical Campus
Huntsville, Alabama, United States
NoesisPharma
Phoenix, Arizona, United States
Local Institution - 0040
Scottsdale, Arizona, United States
Local Institution - 0017
Anaheim, California, United States
Inland Psychiatric Medical Group - Chino
Chino, California, United States
Kaizen Brain Center
La Jolla, California, United States
University of California San Diego - La Jolla
La Jolla, California, United States
Shreenath Clinical Service - Lakewood
Lakewood, California, United States
Accellacare - Sherman Oaks
Sherman Oaks, California, United States
Next Level Clinical Trials
West Covina, California, United States
Alliance Clinical -West Hills
West Hills, California, United States
Local Institution - 0053
Washington D.C., District of Columbia, United States
Arrow Clinical Trials
Daytona Beach, Florida, United States
ClinCloud
Maitland, Florida, United States
Local Institution - 0007
Maitland, Florida, United States
Local Institution - 0022
Miami, Florida, United States
Ocean Blue Medical Research Center
Miami, Florida, United States
Local Institution - 0001
Tampa, Florida, United States
Charter Research - Lady Lake
The Villages, Florida, United States
Advanced Discovery Research
Atlanta, Georgia, United States
CenExel iResearch, LLC
Decatur, Georgia, United States
CenExel iResearch, LLC
Savannah, Georgia, United States
Hawaii Pacific Neuroscience
Honolulu, Hawaii, United States
Local Institution - 0011
Marrero, Louisiana, United States
Local Institution - 0051
South Dartmouth, Massachusetts, United States
Local Institution - 0061
Missoula, Montana, United States
Local Institution - 0062
Omaha, Nebraska, United States
Oasis Clinical Trials
Las Vegas, Nevada, United States
Local Institution - 0059
Livingston, New Jersey, United States
University at Buffalo - UBMD Neurology
Buffalo, New York, United States
The Feinstein Institute for Medical Research
Manhasset, New York, United States
Mid Hudson Medical Research
New Windsor, New York, United States
Local Institution - 0064
Staten Island, New York, United States
Research Central LLC (DBA Ichor Research)
Syracuse, New York, United States
New Hope Clinical Research
Charlotte, North Carolina, United States
Local Institution - 0063
Raleigh, North Carolina, United States
Local Institution - 0023
Cleveland, Ohio, United States
Local Institution - 0058
Philadelphia, Pennsylvania, United States
K2 Medical Research - East Providence
East Providence, Rhode Island, United States
Local Institution - 0031
Chattanooga, Tennessee, United States
Neurology Clinic, P.C.
Cordova, Tennessee, United States
Local Institution - 0033
Nashville, Tennessee, United States
Local Institution - 0060
Austin, Texas, United States
Horizon Clinical Research Center - Houston
Cypress, Texas, United States
ANESC Research
El Paso, Texas, United States
North Pointe Psychiatry - Flower Mound
Flower Mound, Texas, United States
Local Institution - 0020
Houston, Texas, United States
Be Well Clinical Studies
Round Rock, Texas, United States
Boeson Research - Provo
Provo, Utah, United States
Countries
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Central Contacts
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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Role: CONTACT
Phone: 8559073286
Email: [email protected]
First line of the email MUST contain the NCT# and Site #.
Role: CONTACT
Facility Contacts
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Site 0046
Role: primary
Tiffany Schwasinger-Schmidt, Site 0036
Role: primary
Lee Kelley, Site 0048
Role: primary
Site 0040
Role: primary
Site 0017
Role: primary
Nandita Puchakayala, Site 0037
Role: primary
MOHAMMED AHMED, Site 0018
Role: primary
Gabriel Leger, Site 0052
Role: primary
ERIC TATE, Site 0050
Role: primary
Neeraj Gupta, Site 0043
Role: primary
Austina Cho, Site 0057
Role: primary
Leon Barkodar, Site 0028
Role: primary
Site 0053
Role: primary
David Billmeier, Site 0003
Role: primary
Rosemary Laird, Site 0013
Role: primary
Site 0007
Role: primary
Antonio Terrelonge, Site 0010
Role: primary
Site 0001
Role: primary
Jeffrey Norton, Site 0039
Role: primary
David Purselle, Site 0026
Role: primary
Kimball Johnson, Site 0035
Role: primary
Yael Elfassy, Site 0015
Role: primary
Kore Liow, Site 0004
Role: primary
Site 0011
Role: primary
Site 0051
Role: primary
Site 0061
Role: primary
Site 0062
Role: primary
Zinoviy Benzar, Site 0041
Role: primary
Site 0059
Role: primary
Kinga Szigeti, Site 0034
Role: primary
Jeremy Koppel, Site 0049
Role: primary
Sashi Makam, Site 0044
Role: primary
Site 0064
Role: primary
Karl Hafner, Site 0021
Role: primary
Kurian Abraham, Site 0016
Role: primary
Site 0063
Role: primary
Site 0023
Role: primary
Site 0058
Role: primary
john stoukides, Site 0025
Role: primary
Site 0031
Role: primary
Thomas Arnold, Site 0019
Role: primary
Site 0033
Role: primary
Site 0060
Role: primary
Harpaul Gill, Site 0042
Role: primary
Aamr Herekar, Site 0045
Role: primary
Asad Islam, Site 0024
Role: primary
Mark Carlson, Site 0038
Role: primary
Jason Andersen, Site 0027
Role: primary
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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U1111-1313-8997
Identifier Type: OTHER
Identifier Source: secondary_id
IM045-P06
Identifier Type: -
Identifier Source: org_study_id