Study to Evaluate the Efficacy, Safety, and Tolerability of an Anti-MTBR Tau Monoclonal Antibody (BMS-986446) in Participants With Early Alzheimer's Disease

Purpose

The purpose of this study is to assess the effectiveness, safety, and tolerability of BMS-986446 an Anti-MTBR Tau Monoclonal Antibody in participants with Early Alzheimer's Disease.

Condition

  • Alzheimer Disease, Early Onset

Eligibility

Eligible Ages
Between 60 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild AD dementia consistent with the National Institute on Aging and the Alzheimer's Association (NIA-AA) core clinical criteria. - Global Clinical Dementia Rating (CDR) score of 0.5 to 1.0 and a CDR-Memory Box score of 0.5 and greater at screening and Baseline. - Evidence of AD pathology. - Objective impairment in episodic memory as indicated by at least 1 standard deviation below age-adjusted mean in the Wechsler Memory Scale IV-Logical Memory Subtest II (WMS-IV LM II). - Mini Mental Status Examination (MMSE) score ≥ 20 to 28 (inclusive).

Exclusion Criteria

  • Any evidence of a condition that may affect cognition other than AD. - Contraindications to PET imaging. - Inability to tolerate or contraindication to magnetic resonance imaging. - Any serious medical condition that could, in the opinion of the investigator, affect the participant's safety or interfere with study assessments. - Geriatric Depression Scale (GDS) score greater than or equal to 8 at screening. - Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo
  • Other: Placebo
    Specified dose on specified days
Experimental
BMS-986446 Dose A
  • Drug: BMS-986446
    Specified dose on specified days
Experimental
BMS-986446 Dose B
  • Drug: BMS-986446
    Specified dose on specified days

Recruiting Locations

MD First Research - Chandler
Chandler, Arizona 85226-3732
Contact:
Hemant Pandey, Site 0068
520-339-6769

Gilbert Neurology
Gilbert, Arizona 85297-0441
Contact:
Jonathan Hodgson, Site 0102
602-761-9631

Xenoscience Inc. - 21st Century Neurology
Phoenix, Arizona 85004
Contact:
Stephen Flitman, Site 0019
602-265-6500

Perseverance Research Center (PRC)
Scottsdale, Arizona 85253
Contact:
Allan Block, Site 0018
480-471-6132

Imaging Endpoints LLC
Scottsdale, Arizona 85258-4595
Contact:
Nida Laurin, Site 0026
480-290-1547

Center for Neurosciences - Tucson
Tucson, Arizona 85718-6522
Contact:
Michael Badruddoja, Site 0077
520-320-2147

The Banner Alzheimer's Institute - Tucson
Tucson, Arizona 85718-6632
Contact:
Matthew Malone, Site 0038

Pharmacology Research Institute (PRI) - Encino
Encino, California 91316-1511
Contact:
Clifford Feldman, Site 0164
818-705-7451

Neurology Center of North Orange County
Fullerton, California 92835-1040
Contact:
Johnson Moon, Site 0139
714-879-7200

Irvine Center for Clinical Research
Irvine, California 92614-9403
Contact:
Elly Lee, Site 0191
949-753-1663

Healthy Brain Clinic
Long Beach, California 90804-2128
Contact:
Dung Trinh, Site 0234
562-606-5999

Pharmacology Research Institute (PRI) - Los Alamitos
Los Alamitos, California 90720-3589
Contact:
Ashkan Mowla, Site 0142

Neurovations
Napa, California 94558-2415
Contact:
Eric Grigsby, Site 0037
707-287-7866

University of California Davis (UC Davis) - Alzheimer's Disease Center (ADC) - Sacramento
Sacramento, California 95817-2307
Contact:
Doris Chen, Site 0209
925-357-6515

UCSF Medical Center at Mission Bay
San Francisco, California 94143-2350
Contact:
Peter Ljubenkov, Site 0052
415-502-7562

Syrentis Clinical Research
Santa Ana, California 92705-8675
Contact:
John Duffy, Site 0137
714-542-3008

California Neuroscience Research Medical Group, Inc (CNR)
Sherman Oaks, California 91403-2131
Contact:
Thomas Shiovitz, Site 0046
818990-2671

Associated Neurologists, P.C. - Danbury Office
Danbury, Connecticut 06810-4088
Contact:
Behzad Habibi Khameneh, Site 0106
203-748-2551

Yale School Of Medicine
New Haven, Connecticut 06510
Contact:
Ryan O'Dell, Site 0148

Hasbani Neurology
New Haven, Connecticut 06511-5249
Contact:
Mayer Hasbani, Site 0056
212-241-8329

New England Institute for Neurology and Headache (NEINH)
Stamford, Connecticut 06905-1206
Contact:
Peter McAllister, Site 0153
203-914-1900

Neurology of Central Florida
Altamonte Springs, Florida 32714-2436
Contact:
Alicia Cabrera, Site 0022
407-790-4990

JEM Research Institute
Atlantis, Florida 33462-6631
Contact:
Linda Pao, Site 0048
561-968-2933

Neurology Offices of South Florida - Boca Raton
Boca Raton, Florida 33428-2236
Contact:
Brian Costell, Site 0228

SFM Clinical Research, LLC
Boca Raton, Florida 33487-3626
Contact:
Marc Feinberg, Site 0250
561-901-1183

Bradenton Research Center, Inc.
Bradenton, Florida 34205
Contact:
Eric Folkens, Site 0224
941-708-0005

K2 Medical Research - Winter Garden
Clermont, Florida 34711-5933
Contact:
Christopher Galloway, Site 0020
321-500-5252

Arrow Clinical Trials
Daytona Beach, Florida 32117-5532
Contact:
David Billmeier, Site 0009
386-304-7070

Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida 33912-4302
Contact:
Jennifer Springer, Site 0213
239-939-7777

Finlay Medical Research (FMR) Corporation - Greenacres
Greenacres City, Florida 33467
Contact:
Jorge Calle Medina, Site 0059
561-766-2181

Indago Research and Health Center, Inc.
Hialeah, Florida 33012-4170
Contact:
Evelio Sosa, Site 0207
305-825-6588

Health Care Family Rehab & Research Center
Hialeah, Florida 33015-6008
Contact:
Jose Lopez Escobar, Site 0212
305-592-4692

Galiz Research - Palmetto Medical Plaza Location
Hialeah, Florida 33016-1814
Contact:
Jose Gamez, Site 0198
305-805-0921

Charter Research - Lady Lake
Lady Lake, Florida 32159
Contact:
Jeffrey Norton, Site 0151
352-775-1000

Accel Research Sites - Lakeland Clinical Research Unit
Lakeland, Florida 33805-2208
Contact:
James Andersen, Site 0146
863-940-2087

ClinCloud LLC
Maitland, Florida 32751-3320
Contact:
Reinhard Rott, Site 0192
602-316-8924

Neurology & Movement Disorders Healthcare
Maitland, Florida 32751
Contact:
Shelia Baez-Torres, Site 0143
407-500-5252

Merritt Island Medical Research
Merritt Island, Florida 32952-3616
Contact:
David Kirk, Site 0027

South Florida Research Phase I-IV, Inc
Miami Springs, Florida 33166-7225
Contact:
Belkis Delgado, Site 0197
305-418-0847

Homestead Associates in Research, Inc.
Miami, Florida 33032
Contact:
Angel Carrasco, Site 0203
305-246-0873

Premier Clinical Research Institute - Miami
Miami, Florida 33122-1335
Contact:
Emelina Arocha, Site 0058
305-445-5994

Project 4 Research
Miami, Florida 33125-4719
Contact:
Ibrahim Menendez Perez, Site 0034
786-536-5755

Finlay Medical Research Corp.
Miami, Florida 33126
Contact:
Lilia Rodriguez Ables, Site 0211
305-459-3578

CCM Clinical Research Group
Miami, Florida 33133-4231
Contact:
Francisco Ricart, Site 0195
208-346-8900

Vitae Research Center
Miami, Florida 33135-2957
Contact:
Mercedes Ponce De Leon, Site 0014
786-288-2598

Advance Medical Research Center
Miami, Florida 33135-2968
Contact:
Ana Acosta, Site 0005
786-360-4423

Advanced Clinical Research Network, Corp
Miami, Florida 33135-4759
Contact:
Gil Fernandez-Yera, Site 0208
305-702-1594

Miami Jewish Health Systems
Miami, Florida 33137-2706
Contact:
Marc Agronin, Site 0008
305-751-8626

Elite Clinical Research
Miami, Florida 33144
Contact:
Gelasio Baras, Site 0199
608-848-8900

Global Life Research LLC
Miami, Florida 33155-4630
Contact:
Frank Carlos Alvarez Li, Site 0206
305-905-5218

Ivetmar Medical Group LLC
Miami, Florida 33155-6540
Contact:
Aliuska Alvarez, Site 0176
754-800-9075

Hope Research Network, LLC
Miami, Florida 33166-2710
Contact:
Jorge Jorge, Site 0071
786-681-4959

EZY Medical Research
Miami, Florida 33175-3598
Contact:
Manuel Francisco Fernandez, Site 0156
786-483-8162

First Choice Neurology - Medical Arts Neurology
Miami, Florida 33176-2151
Contact:
Victor Faradji-Hazan, Site 0249
605-595-4041

IMIC Research
Miami, Florida 33176-7947
Contact:
Leon Ramon, Site 0039
786-600-7005

Miami Dade Medical Research Institute
Miami, Florida 33176
Contact:
Orlando Puente, Site 0225
305-722-7210

Aqualane Clinical Research
Naples, Florida 34105
Contact:
William Justiz, Site 0217
239-529-6780

Suncoast Clinical Research
New Port Richey, Florida 34652-4020
Contact:
Cathy Barnes, Site 0017
727-849-4131

Renstar Medical Research
Ocala, Florida 34471
Contact:
John Nardandrea, Site 0144
352-629-5800

K2 Medical Research - South Orlando
Orlando, Florida 32806-8521
Contact:
Elizabeth Phillips, Site 0202
407-232-9263

Combined Research Orlando (CRO)
Orlando, Florida 32807
Contact:
Eric Carbonell, Site 0219
407-440-4493

Headlands Research - Orlando
Orlando, Florida 32819-8031
Contact:
Uzma Khan, Site 0035
407-705-3471

Brain, Spine and Pain Institute of Lake Nona
Orlando, Florida 32832
Contact:
Gilbert Mbeo, Site 0238
407-554-9473

Progressive Medical Research
Port Orange, Florida 32127-5170
Contact:
Alexander White, Site 0210
386-304-7070

Intercoastal Medical Group, Inc. - Hyde Park East & West
Sarasota, Florida 34239-3228
Contact:
Mauricio Concha, Site 0204
941-203-3750

Alzheimer's Research and Treatment Center Stuart
Stuart, Florida 34997-5765
Contact:
Adam Falchook, Site 0012
561-209-2400

Brain Matters Research - Stuart
Stuart, Florida 34997-6405
Contact:
Paayal Patel, Site 0136
561-374-8461

K2 Medical Research - Tampa
Tampa, Florida 33607-6210
Contact:
Kelley Yokum, Site 0200
813-800-5252

Baycare Clinical Research, LLC
Tampa, Florida 33607-6616
Contact:
Arnaldo Orellana, Site 0080
813-368-5738

Axiom Brain Health
Tampa, Florida 33609-4049
Contact:
Susan Steen, Site 0087
813-353-9613

Johnnie B. Byrd, Sr. Alzheimer's Foundation, Inc
Tampa, Florida 33613-4808
Contact:
Amanda Smith, Site 0042
813-974-4355

Clincloud Clinical Research
Viera, Florida 32940-7948
Contact:
Rosemary Laird, Site 0194
407-636-4031

Alzheimer's Research and Treatment Center - Wellington Location
Wellington, Florida 33414-9320
Contact:
David Watson, Site 0011
561-209-2400

Palm Beach Neurology Premiere Research Institute
West Palm Beach, Florida 33407-3234
Contact:
Paul Winner, Site 0223
561-845-0500

Quantum Laboratories, Inc - West Palm Beach Office
West Palm Beach, Florida 33409-6611
Contact:
Jose De La Gandara, Site 0149
954-786-7331

Waypoint Research LLC
Windermere, Florida 34786-8919
Contact:
Craig Curtis, Site 0029
352-500-5252

Conquest Research LLC
Winter Park, Florida 32789-1848
Contact:
Rekha Gandhi, Site 0101
321-285-2369

Charter Research - Winter Park
Winter Park, Florida 32792
Contact:
Edgardo Rivera, Site 0154
407-863-1326

Columbus Memory Center
Columbus, Georgia 31909-1692
Contact:
Jonathan Liss, Site 0105
706-577-3529

Cognition Health - Chicago
Chicago, Illinois 60611-2818
Contact:
Antonio Iglesias, Site 0236
312-971-3318

Great Lakes Clinical Trials
Chicago, Illinois 60640-2831
Contact:
Jeffrey Ross, Site 0021
847-252-7300

Alexian Brothers Neurosciences Institute
Elk Grove Village, Illinois 60007-3362
Contact:
Concetta Forchetti, Site 0161
847-593-8553

Great Lakes Clinical Trials d/b/a Flourish Research Gurnee
Gurnee, Illinois 60031
Contact:
Samuel Moltz, Site 0003
847-915-6044

Advocate Lutheran General Hospital
Park Ridge, Illinois 60068
Contact:
Darren Gitelman, Site 0145
847-720-6464

Southern Illinois University School of Medicine - SIU Neurology Clinic
Springfield, Illinois 62702-4968
Contact:
Jennifer Arnold, Site 0081
217-545-7197

Copley Clinical
Boston, Massachusetts 02116
Contact:
Dyanna Domilici, Site 0235
617-934-5743

Boston Clinical Trials
Boston, Massachusetts 02131-2515
Contact:
Deborah Green-LaRoche, Site 0025
617-477-4868

Alzheimer Disease Center
Braintree, Massachusetts 02184
Contact:
Malini Nair, Site 0015
617-639-5006

Neurology Center of New England, PC
Foxboro, Massachusetts 02035-1309
Contact:
Salvatore Napoli, Site 0174
781-551-5812

ActivMed Practices & Research, Inc. - Methuen
Methuen, Massachusetts 01844-5864
Contact:
Adam Tanzer, Site 0118
978-655-7155

Boston Center for Memory
Newton, Massachusetts 02459-3328
Contact:
Paul Solomon, Site 0040
413-281-0577

Office of Donald S. Marks, M.D., P.C.
Plymouth, Massachusetts 02360-7223
Contact:
Donald Marks, Site 0120
508-269-0403

Adams Clinical Trials, LLC
Watertown, Massachusetts 02472-4153
Contact:
Stephanie Rutrick, Site 0045
813-404-7682

ActivMed Practices & Research, Inc. - Portsmouth
Portsmouth, New Hampshire 03801-6822
Contact:
Marc Shay, Site 0119
603-234-5237

Princeton Medical Institute
Princeton, New Jersey 08540-2859
Contact:
Sanjay Varma, Site 0031
609-921-3555

Advanced Memory Research Institute of NJ
Toms River, New Jersey 08755-5043
Contact:
Sanjiv Sharma, Site 0062
732-341-9500

Neurological Associates of Albany, P.C.
Albany, New York 12208-3464
Contact:
Richard Holub, Site 0060
518-426-0575

Dent Neurologic Institute - Amherst
Amherst, New York 14226-1727
Contact:
Horacio Capote, Site 0157
716-250-2000

The Feinstein Institute for Medical Research
Manhasset, New York 11030-3816
Contact:
Marc Gordon, Site 0061
516-562-3492

Berman Clinical
New York, New York 10029-5611
Contact:
Shama Farooq, Site 0205
646-970-7804

Berman Clinical
New York, New York 10029-5611
Contact:
Patricia Walsh, Site 0214
773-472-3704

Icahn School of Medicine at Mount Sinai (ISMMS) - Alzheimer's Disease Research Center
New York, New York 10029-6504
Contact:
Laili Soleimani, Site 0104

Columbia University Medical Center - The Neurological Institute of New York
New York, New York 10032-3726
Contact:
Lawrence Honig, Site 0133
212-305-0851

Alzheimer's Memory Center
Matthews, North Carolina 28105-8336
Contact:
Mohammad Bolouri, Site 0043
7043644000ext225

Insight Clinical Trials, LLC
Beachwood, Ohio 44122
Contact:
Mark Stillman, Site 0155
216-526-1843

Neurology Diagnostics, Inc.
Dayton, Ohio 45459-4296
Contact:
Joel Vandersluis, Site 0215
305-456-7782

Keystone Clinical Studies, LLC
Plymouth Meeting, Pennsylvania 19462-7401
Contact:
Cameron Olezene, Site 0023
610-277-8073

Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island 02914
Contact:
john stoukides, Site 0024
401-435-8950

Butler Hospital
Providence, Rhode Island 02906-4800
Contact:
Meghan Riddle, Site 0163
401-455-6403

Neurology Clinic, P.C. - Germantown Park Location
Cordova, Tennessee 38018-4254
Contact:
Kendrick Henderson, Site 0132
901-866-9252

KCA Neurology
Franklin, Tennessee 37067-5922
Contact:
Gretchen Campbell, Site 0140
615-550-1800

Vanderbilt University Medical Center
Nashville, Tennessee 37212
Contact:
Lealani Acosta, Site 0222
615-936-0060

Senior Adults Specialty Research
Austin, Texas 78757-8046
Contact:
Jaron Winston, Site 0069
512-407-8628

Gadolin Research
Beaumont, Texas 77702
Contact:
Kandasami Senthilkumar, Site 0033
409-331-6040

Kerwin Research Center and Memory Care
Dallas, Texas 75231-4316
Contact:
Diana Kerwin, Site 0051
312-206-5534

Memorial Neurological Association - Main Office
Houston, Texas 77074-1812
Contact:
Nelson Berrios, Site 0016

Re:Cognition Health - Fairfax
Fairfax, Virginia 22031-5216
Contact:
Raymond Turner, Site 0196
734-417-0994

National Clinical Research - Richmond, Inc.
Richmond, Virginia 23294
Contact:
John Scott, Site 0168
804-755-2300

More Details

NCT ID
NCT06268886
Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center