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

Part of paid clinical trials in Homewood, Alabama.

Sponsor
Celgene
Study ID
NCT06808984
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
55 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • BMS-986368 — DRUG
    Specified dose on specified days
  • Placebo — DRUG
    Specified dose on specified days

Study Details

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.

Key Dates

Start date
Jun 9, 2025
Status verified
Jun 2026
Primary completion
Nov 26, 2027
Completion
Jan 7, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BMS-986368 Dose 1
  • Experimental: BMS-986368 Dose 2
  • Placebo Comparator: Placebo

Primary Outcome Measure

Change in Cohen-Mansfield Agitation Inventory (CMAI) total score from baseline [ Time Frame: Up to Week 8 ]

Central Contacts

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
    855-907-3286
    [email protected]
  • First line of the email MUST contain NCT # and Site #.

Locations (53)

FacilityCityStateZIPSite coordinators
Local Institution - 0046HomewoodAlabama35209
Site 0046
University of Alabama - Huntsville Regional Medical CampusHuntsvilleAlabama35801
Tiffany Schwasinger-Schmidt, Site 0036
256-551-4512
Local Institution - 0048PhoenixArizona85028-
Local Institution - 0040ScottsdaleArizona85260
Site 0040
Local Institution - 0017AnaheimCalifornia92805
Site 0017
Inland Psychiatric Medical Group.ChinoCalifornia91710
Nandita Puchakayala, Site 0037
909-488-9116
Kaizen Brain CenterLa JollaCalifornia92037
MOHAMMED AHMED, Site 0018
214-893-0542
University of California San Diego - La JollaLa JollaCalifornia92037
Gabriel Leger, Site 0052
858-246-1303
Shreenath Clinical Service - LakewoodLakewoodCalifornia90805
ERIC TATE, Site 0050
714-717-6039
Accellacare - Sherman OaksSherman OaksCalifornia91403
Neeraj Gupta, Site 0043
562-548-8500
Next Level Clinical TrialsWest CovinaCalifornia91790
Austina Cho, Site 0057
714-999-6688
Local Institution - 0028West HillsCalifornia91307-
University of Colorado Anschutz Medical CampusAuroraColorado80045
Samantha Holden, Site 0066
303-724-2046
Local Institution - 0053Washington D.C.District of Columbia20060-
Local Institution - 0067Washington D.C.District of Columbia20007
Site 0067
Arrow Clinical TrialsDaytona BeachFlorida32117
David Billmeier, Site 0003
386-278-8000
ClinCloudMaitlandFlorida32751
Rosemary Laird, Site 0013
717-357-1569
Local Institution - 0007MaitlandFlorida32751
Site 0007
Local Institution - 0010MiamiFlorida33166-
Local Institution - 0022MiamiFlorida33125-
Local Institution - 0001TampaFlorida33607
Site 0001
Charter Research - Lady LakeThe VillagesFlorida32162
Jeffrey Norton, Site 0039
352-775-1000
Local Institution - 0026AtlantaGeorgia30318-
CenExel iResearch, LLCDecaturGeorgia30030
Kimball Johnson, Site 0035
404-537-1281
CenExel iResearch, LLCSavannahGeorgia31405
Yael Elfassy, Site 0015
912-744-0800
Local Institution - 0004HonoluluHawaii96817-
Local Institution - 0011MarreroLouisiana70072
Site 0011
Local Institution - 0051South DartmouthMassachusetts02747
Site 0051
Boeson ResearchMissoulaMontana59804
Lisa Koehl, Site 0061
406-543-9700
Be Well Clinical Studies - OmahaOmahaNebraska68144
John Puente, Site 0062
402-937-9293
Local Institution - 0041Las VegasNevada89121-
Local Institution - 0059LivingstonNew Jersey07039
Site 0059
University at Buffalo - UBMD NeurologyBuffaloNew York14203
Kinga Szigeti, Site 0034
281-630-2316
The Feinstein Institute for Medical ResearchManhassetNew York11030
Jeremy Koppel, Site 0049
516-562-3492
Mid Hudson Medical ResearchNew WindsorNew York12553
Sashi Makam, Site 0044
845-674-9398
Local Institution - 0064Staten IslandNew York10309-
Research Central LLC (DBA Ichor Research)SyracuseNew York13210
Karl Hafner, Site 0021
315-529-0766
New Hope Clinical ResearchCharlotteNorth Carolina28211
Kurian Abraham, Site 0016
980-209-9784
UNC Health REX HospitalRaleighNorth Carolina27607
Sandeep Vaishnavi, Site 0063
919-784-1198
Cleveland ClinicClevelandOhio44195
Kasia Rothenberg, Site 0023
216-403-6847
Thomas Jefferson University - Vickie & Jack Farber Institute for NeurosciencePhiladelphiaPennsylvania19107
James Ellison, Site 0058
215-503-2823
K2 Medical Research - East ProvidenceEast ProvidenceRhode Island02914
john stoukides, Site 0025
401-435-8950
Local Institution - 0031ChattanoogaTennessee37421
Site 0031
Neurology Clinic, P.C.CordovaTennessee38018
Thomas Arnold, Site 0019
901-866-9252
Vanderbilt University Medical Center- VillageNashvilleTennessee37212
Joshua Smith, Site 0033
601-594-0792
Pinnacle Clinical ResearchAustinTexas78626
Rohit Puskoor, Site 0060
817-602-5188
Horizon Clinical Research Center - HoustonCypressTexas77065
Harpaul Gill, Site 0042
949-491-0710
ANESC ResearchEl PasoTexas79912
Aamr Herekar, Site 0045
505-903-1715
North Pointe Psychiatry - Flower MoundFlower MoundTexas75028
Asad Islam, Site 0024
469-444-2244
Local Institution - 0020HoustonTexas77030-
Stryde Research - PlanoPlanoTexas75093
Peter Brokish, Site 0065
214-407-8640
Be Well Clinical StudiesRound RockTexas78681
Mark Carlson, Site 0038
000-000-0000
Boeson Research - ProvoProvoUtah84604
Jason Andersen, Site 0027
385-392-2200

Find similar trials in Homewood, AL

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Local Institution - 0046· Homewood, ALUniversity of Alabama - Huntsville Regional Medical Campus· Huntsville, ALLocal Institution - 0048· Phoenix, AZLocal Institution - 0040· Scottsdale, AZLocal Institution - 0017· Anaheim, CAInland Psychiatric Medical Group.· Chino, CA

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