A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (MINDSET 2)

Part of paid clinical trials in Fullerton, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT06976203
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • KarXT — DRUG
    Specified dose on specified days
  • KarX-EC — DRUG
    Specified dose on specified days
  • Placebo — OTHER
    Specified dose on specified days

Study Details

The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease

Key Dates

Start date
Jul 21, 2025
Status verified
Jun 2026
Primary completion
Sep 11, 2028
Completion
Feb 23, 2029

Study Design

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

Arms

  • Active Comparator: KarXT + KarX-EC
  • Placebo Comparator: Placebo

Primary Outcome Measure

Change from baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11) [ Time Frame: At week 24 ]

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 (30)

FacilityCityStateZIPSite coordinators
Fullerton Neurology and Headache CenterFullertonCalifornia92835
Jack Florin, Site 0072
714-381-0801
Inglewood ClinicalInglewoodCalifornia90301
Edward Zamrini, Site 0091
706-863-9595
Irvine Clinical ResearchIrvineCalifornia92614
Elly Lee, Site 0095
949-753-1663
Local Institution - 0083Palo AltoCalifornia94304
Site 0083
Local Institution - 0069San DiegoCalifornia92103-
Research of the RockiesColorado SpringsColorado80919
Adam Wolff, Site 0088
303-715-9024
Neuropsychiatric Research Center of Southwest FloridaFort MyersFlorida33912
Jennifer Springer, Site 0090
239-939-7777
Local Institution - 0086HallandaleFlorida33009-
Jacksonville Center for Clinical ResearchJacksonvilleFlorida32216
Steven Toenjes, Site 0092
904-673-1252
K2 MEDICAL Research THE VILLAGESLady LakeFlorida32159
Craig Curtis, Site 0114
407-426-9299
Intercoastal Medical GroupSarasotaFlorida34239
Mauricio Concha, Site 0082
941-203-3750
USF Health Byrd Alzheimer's InstituteTampaFlorida33613
Amanda Smith, Site 0084
813-974-4355
Alzheimer's Research and Treatment CenterWellingtonFlorida33414
David Watson, Site 0089
561-209-2400
Great Lakes Clinical Trials - AndersonvilleChicagoIllinois60640
Jeffrey Ross, Site 0093
847-252-7300
Southern Illinois University School of MedicineSpringfieldIllinois62702
Jennifer Arnold, Site 0070
217-545-7197
Josephson Wallack Munshower Neurology, PCIndianapolisIndiana46256
Kristi George, Site 0071
317-537-6088
Local Institution - 0080WatertownMassachusetts02472
Site 0080
QUEST Research InstituteFarmington HillsMichigan48334
Aaron Ellenbogen, Site 0073
248-957-8940
Private Practice - Dr. Ronald Louis SchwartzHattiesburgMississippi39401
Ronald Schwartz, Site 0085
601-606-0911
Local Institution - 0119RidgewoodNew Jersey07450-
The Cognitive and Research Center of New JerseySpringfieldNew Jersey07081
Raminder Parihar, Site 0094
973-850-4622
Advanced Clinical InstituteWest Long BranchNew Jersey07764
Mark Ornstein, Site 0075
732-807-4700
Neurological Associates AlbanyAlbanyNew York12208
Richard Holub, Site 0077
518-426-0575
Dent Neurosciences Research Center, IncAmherstNew York14226
Horacio Capote, Site 0068
716-250-2000
University at Buffalo - UBMD NeurologyBuffaloNew York14203
Kinga Szigeti, Site 0087
281-630-2316
Local Institution - 0078Lake SuccessNew York11042-
Keystone Clinical StudiesPlymouth MeetingPennsylvania19462
Cameron Olezene, Site 0105
610-277-8073
Local Institution - 0081DallasTexas75231
Site 0081
Central Texas Neurology Consultants, PARound RockTexas78681
Elizabeth Peckham, Site 0079
443-852-2085
Rainier Clinical Research CenterRentonWashington98057
Sheryl Marks, Site 0076
425-251-1722

Find similar trials in Fullerton, CA

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Fullerton Neurology and Headache Center· Fullerton, CAInglewood Clinical· Inglewood, CAIrvine Clinical Research· Irvine, CALocal Institution - 0083· Palo Alto, CALocal Institution - 0069· San Diego, CAResearch of the Rockies· Colorado Springs, CO

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