AgitationPhase 2NCT06808984

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

A Phase 2 study testing BMS-986368 in people with Agitation and Alzheimer Disease, run by Celgene at 77 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 55 to 90 years
Conditions the study is for: Agitation, Alzheimer Disease
What is being tested?: BMS-986368
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 120 participants
Where: 77 sitesin 4 countries
Study dates: 9 Jun 2025to 7 Jan 2028
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

77 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact

855-907-3286

Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #. contact

Country

City, postcode or hospital

Sites recruiting now only

77 sites in 4 countries

United States60 sites, 45 recruiting

Local Institution - 0017
Anaheim, California, 92805
Site 0017
Not yet recruiting
Local Institution - 0089
Ardmore, Oklahoma, 73401
Site 0089
Not yet recruiting
Local Institution - 0026
Atlanta, Georgia, 30318
Completed
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Samantha Holden, Site 0066, 303-724-2046
Recruiting
Pinnacle Clinical Research
Austin, Texas, 78626
Rohit Puskoor, Site 0060, 817-602-5188
Recruiting
University at Buffalo - UBMD Neurology
Buffalo, New York, 14203
Kinga Szigeti, Site 0034, 281-630-2316
Recruiting
New Hope Clinical Research
Charlotte, North Carolina, 28211
Kurian Abraham, Site 0016, 980-209-9784
Recruiting
Local Institution - 0031
Chattanooga, Tennessee, 37421
Site 0031
Not yet recruiting
Inland Psychiatric Medical Group.
Chino, California, 91710
Nandita Puchakayala, Site 0037, 909-488-9116
Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Kasia Rothenberg, Site 0023, 216-403-6847
Recruiting
Local Institution - 0087
Columbus, Ohio, 43221
Site 0087
Not yet recruiting
Neurology Clinic, P.C.
Cordova, Tennessee, 38018
Thomas Arnold, Site 0019, 901-866-9252
Recruiting
Horizon Clinical Research Center - Houston
Cypress, Texas, 77065
Harpaul Gill, Site 0042, 949-491-0710
Recruiting
Arrow Clinical Trials
Daytona Beach, Florida, 32117
David Billmeier, Site 0003, 386-278-8000
Recruiting
CenExel iResearch, LLC
Decatur, Georgia, 30030
Kimball Johnson, Site 0035, 404-537-1281
Recruiting
ANESC Research
El Paso, Texas, 79912
Aamr Herekar, Site 0045, 505-903-1715
Recruiting
Local Institution - 0086
Elgin, Illinois, 60123
Withdrawn
Local Institution - 0024
Flower Mound, Texas, 75028
Completed
K2 Medical Research
Foxborough, Massachusetts, 02035
john stoukides, Site 0025, 401-435-8950
Recruiting
Local Institution - 0046
Homewood, Alabama, 35209
Site 0046
Not yet recruiting
Local Institution - 0004
Honolulu, Hawaii, 96817
Completed
Local Institution - 0020
Houston, Texas, 77030
Withdrawn
University of Alabama - Huntsville Regional Medical Campus
Huntsville, Alabama, 35801
Tiffany Schwasinger-Schmidt, Site 0036, 256-551-4512
Recruiting
Kaizen Brain Center
La Jolla, California, 92037
MOHAMMED AHMED, Site 0018, 214-893-0542
Recruiting
Local Institution - 0052
La Jolla, California, 92037
Completed
Shreenath Clinical Service - Lakewood
Lakewood, California, 90805
ERIC TATE, Site 0050, 714-717-6039
Recruiting
Local Institution - 0041
Las Vegas, Nevada, 89121
Completed
Local Institution - 0059
Livingston, New Jersey, 07039
Site 0059
Not yet recruiting
ClinCloud
Maitland, Florida, 32751
Rosemary Laird, Site 0013, 717-357-1569
Recruiting
Local Institution - 0007
Maitland, Florida, 32751
Site 0007
Not yet recruiting
The Feinstein Institute for Medical Research
Manhasset, New York, 11030
Jeremy Koppel, Site 0049, 516-562-3492
Recruiting
Local Institution - 0011
Marrero, Louisiana, 70072
Site 0011
Not yet recruiting
Local Institution - 0022
Miami, Florida, 33125
Withdrawn
Local Institution - 0010
Miami, Florida, 33166
Completed
Local Institution - 0061
Missoula, Montana, 59804
Completed
Vanderbilt University Medical Center- Village
Nashville, Tennessee, 37212
Joshua Smith, Site 0033, 601-594-0792
Recruiting
Mid Hudson Medical Research
New Windsor, New York, 12553
Sashi Makam, Site 0044, 845-674-9398
Recruiting
Be Well Clinical Studies - Omaha
Omaha, Nebraska, 68144
John Puente, Site 0062, 402-937-9293
Recruiting
Thomas Jefferson University - Vickie & Jack Farber Institute for Neuroscience
Philadelphia, Pennsylvania, 19107
James Ellison, Site 0058, 215-503-2823
Recruiting
Local Institution - 0048
Phoenix, Arizona, 85028
Completed
Stryde Research - Plano
Plano, Texas, 75093
Peter Brokish, Site 0065, 214-407-8640
Recruiting
Boeson Research - Provo
Provo, Utah, 84604
Jason Andersen, Site 0027, 385-392-2200
Recruiting
UNC Health REX Hospital
Raleigh, North Carolina, 27607
Sandeep Vaishnavi, Site 0063, 919-784-1092
Recruiting
Local Institution - 0091
Richardson, Texas, 75082
Site 0091
Not yet recruiting
Be Well Clinical Studies
Round Rock, Texas, 78681
Mark Carlson, Site 0038, 000-000-0000
Recruiting
CenExel iResearch, LLC
Savannah, Georgia, 31405
Yael Elfassy, Site 0015, 912-744-0800
Recruiting
Local Institution - 0040
Scottsdale, Arizona, 85260
Site 0040
Not yet recruiting
Local Institution - 0043
Sherman Oaks, California, 91403
Completed
Local Institution - 0051
South Dartmouth, Massachusetts, 02747
Site 0051
Not yet recruiting
Local Institution - 0064
Staten Island, New York, 10309
Completed
Local Institution - 0088
Sterling Heights, Michigan, 48312
Site 0088
Not yet recruiting
Research Central LLC (DBA Ichor Research)
Syracuse, New York, 13210
Karl Hafner, Site 0021, 315-529-0766
Recruiting
Local Institution - 0001
Tampa, Florida, 33607
Site 0001
Not yet recruiting
University of South Florida, Department of Psychiatry and Behavioral Neurosciences
Tampa, Florida, 33613
Ram Bishnoi, Site 0080, 813-396-0738
Recruiting
Charter Research - Lady Lake
The Villages, Florida, 32162
Jeffrey Norton, Site 0039, 352-775-1000
Recruiting
Ocean Medical Research
Toms River, New Jersey, 08755
Sam Khorrami, Site 0081, 732-505-5492
Recruiting
Georgetown University
Washington D.C., District of Columbia, 20057
Brigid Reynolds, Site 0067, 202-687-3350
Recruiting
Local Institution - 0053
Washington D.C., District of Columbia, 20060
Withdrawn
Next Level Clinical Trials
West Covina, California, 91790
Austina Cho, Site 0057, 714-999-6688
Recruiting
Local Institution - 0028
West Hills, California, 91307
Completed

Other trials in United States

Argentina7 sites, 7 recruiting

Local Institution - 0069
Buenos Aires, C1405BOA
Site 0069
Not yet recruiting
Local Institution - 0068
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1060AAE
Site 0068
Not yet recruiting
Local Institution - 0074
Córdoba, Córdoba Province, X5147
Site 0074
Not yet recruiting
Local Institution - 0075
Córdoba, 5004
Site 0075
Not yet recruiting
Local Institution - 0071
Mar del Plata, Buenos Aires, 7600
Site 0071
Not yet recruiting
Local Institution - 0072
Mendoza, 5500
Site 0072
Not yet recruiting
Local Institution - 0073
Santiago del Estero, 4200
Site 0073
Not yet recruiting

Other trials in Argentina

China6 sites, 6 recruiting

Local Institution - 0092
Beijing, Beijing Municipality, 100730
Site 0092
Not yet recruiting
Local Institution - 0083
Hangzhou, Zhejiang, 310014
Site 0083
Not yet recruiting
Local Institution - 0084
Hefei, Anhui, 230022
Site 0084
Not yet recruiting
Local Institution - 0085
Nanjing, Jiangsu, 210029
Site 0085
Not yet recruiting
Local Institution - 0082
Shanghai Shi, Shanghai Municipality, 200030
Site 0082
Not yet recruiting
Local Institution - 0093
Wuhan, Hubei, 430060
Site 0093
Not yet recruiting

Other trials in China

Australia4 sites, 4 recruiting

Local Institution - 0077
Darlinghurst, 2010
Site 0077
Not yet recruiting
Local Institution - 0090
Daw Park, South Australia, 5041
Site 0090
Not yet recruiting
Local Institution - 0076
Macquarie Park, New South Wales, 2113
Site 0076
Not yet recruiting
Local Institution - 0078
Nedlands, Western Australia, 6009
Site 0078
Not yet recruiting

Other trials in Australia

About this study

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)

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.

Conditions: Agitation, Alzheimer Disease
Being tested: BMS-986368, Placebo
Medical subject headings: Psychomotor Agitation, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BMS-986368Drug
Also called CC-97489
Specified dose on specified days
PlaceboDrug
Specified dose on specified days

Study groups in NCT06808984
Study group	Role	What they receive
BMS-986368 Dose 1	Experimental	Not described Receives: Drug: BMS-986368
BMS-986368 Dose 2	Experimental	Not described Receives: Drug: BMS-986368
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Cohen-Mansfield Agitation Inventory (CMAI) total score from baseline
The CMAI is a scale administered by qualified rater based on caregiver's input on 29 items that assess the frequency of manifestations of agitated behaviors in older adults. Each item is rated on a 7-point scale: 1 = "never", 2 = "less than once a week", 3 = "once or twice a week", 4 = "several times a week", 5 = "once or twice a day", 6 = "several times a day" and 7 = "several times per hour." Ratings pertain to the period of time over the previous 2 weeks preceding administration of the CMAI. CMAI total scores range from 29 to 203.
Measured: Up to Week 8

Secondary outcomes (17)

Change in Clinical Global Impression-Severity (CGI-S)
Measured: Up to Week 8
Change in CMAI-International Psychogeriatric Association (CMAI-IPA) Total Score
Measured: Up to Week 8
CMAI sub-score change in Aggressive Behaviors
Measured: Up to Week 8
CMAI sub-score change in Physically Non-aggressive Behaviors
Measured: Up to Week 8
CMAI sub-score change in Verbally Agitated Behaviors
Measured: Up to Week 8
Change in Neuropsychiatric Inventory Nursing Home Version (NPI-NH) Total Score
Measured: Up to Week 8
Change in NPI-NH Agitation/Aggression Domain Score
Measured: Up to Week 8
Change in NPI-NH Occupational Disruptiveness for Agitation/aggression Domain
Measured: Up to Week 8
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Measured: Up to Day 28 After Last Dose
Number of Participants with Serious Adverse Events (SAEs)
Measured: Up to Day 28 After Last Dose
Number of Participants with Adverse Events (AEs)
Measured: Up to Day 28 After Last Dose
Number of Participants with Clinically Significant Laboratory Abnormalities
Measured: Up to 28 Days After Last Dose
Change in Suicidal Ideation Assessed by Sheehan-Suicidality Tracking Scale (S-STS)
Measured: Up to Day 28 After Last Dose
Change in Behaviour Assessed by Sheehan-Suicidality Tracking Scale (S-STS)
Measured: Up to Day 28 After Last Dose
Abuse Potential Assessed by the Cannabis Withdrawal Scale (CWS)
Measured: Up to Day 21 After Last Dose
Withdrawal Symptoms Assessed by the Cannabis Withdrawal Scale (CWS)
Measured: Up to Day 21 After Last Dose
Plasma Concentrations of BMS-986368
Measured: Up to Week 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Jun 20257 Jan 2028

First posted5 Feb 2025
Study start9 Jun 2025
Primary completion26 Nov 2027 (estimated)
Study completion7 Jan 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AgitationStudies of the same condition, open and under way.
More trials run by CelgeneThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06808984
Sponsor's protocol ID: IM045-P06
Other IDs: U1111-1313-8997
Status last verified: Oct 2026
First submitted: 24 Jan 2025
Last updated: 6 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Interested in taking part?

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286

Clinical.Trials@bms.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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RecruitingPhase 3
A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)
Alzheimer Disease, Agitation
Not yet recruitingPhase 3
Effect of Nebulized Lignocaine on Emergence Agitation After Sevoflurane Anesthesia in Pediatric Patients Undergoing Tonsillectomy
Emergence Agitation, Emergence Delirium

All Agitation trials