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

Alzheimer Disease, Early Onset Clinical Trial

— TargetTau-1  

Official title:

A Randomized, Double-blind, Placebo-controlled, Global, Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986446, an Anti-MTBR Tau Monoclonal Antibody, in Participants With Early Alzheimer's Disease (TargetTau-1)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06268886
• Other study ID #: CN008-0003
• Secondary ID: 2023-504840-32-0
• Status: Recruiting
• Phase: Phase 2
• Start date: March 20, 2024
• Est. completion date: November 16, 2027

Study information

• Verified date: June 2024
• Source: Bristol-Myers Squibb
• Contact: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 475
• Est. completion date: November 16, 2027
• Est. primary completion date: August 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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 = 22 to 30 (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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer Disease, Early Onset

Intervention

Drug:
• BMS-986446
Specified dose on specified days

Other:
• Placebo
Specified dose on specified days

Locations

Country	Name	City	State
Australia	Local Institution - 0115	Carlton North	Victoria
Australia	Local Institution - 0002	Darlinghurst	New South Wales
Australia	Local Institution - 0111	East Gosford	New South Wales
Australia	Local Institution - 0093	Heidelberg	Victoria
Australia	Local Institution - 0170	Macquarie Park	New South Wales
Australia	Local Institution - 0001	Malvern	Victoria
Australia	Local Institution - 0125	Melbourne	Victoria
Australia	Local Institution - 0094	Nedlands	Western Australia
Australia	Local Institution - 0147	Parkville	Victoria
Australia	Local Institution - 0116	Southport	Queensland
Belgium	Local Institution - 0122	Anderlecht	Brussels
Belgium	Local Institution - 0175	Antwerpen	Brussel
Belgium	Local Institution - 0097	Brussels
Belgium	Local Institution - 0082	Kortrijk	VWV
Belgium	Local Institution - 0076	Leuven
Belgium	Local Institution - 0078	Liege	WLG
Canada	Local Institution - 0113	Greenfield Park	Quebec
Canada	Local Institution - 0075	Montreal	Quebec
Canada	Local Institution - 0193	Montreal	Quebec
Canada	Local Institution - 0112	Ottawa	Ontario
Canada	Local Institution - 0053	Quebec
Canada	Local Institution - 0044	Toronto	Ontario
Canada	Local Institution - 0047	Toronto	Ontario
Canada	Local Institution - 0109	Toronto	Ontario
France	Local Institution - 0066	Limoges cedex
France	Local Institution - 0084	Rouen
France	Local Institution - 0131	Toulouse
Japan	Local Institution - 0185	Bunkyo-Ku	Tokyo
Japan	Local Institution - 0226	Chuo-Ku
Japan	Local Institution - 0218	Hachioji-Shi
Japan	Local Institution - 0190	Himeji-shi
Japan	Local Institution - 0188	Kasukabe-Shi
Japan	Local Institution - 0179	Kodaira-Shi
Japan	Local Institution - 0186	Kurashiki-Shi
Japan	Local Institution - 0221	Musashimurayama-Shi
Japan	Local Institution - 0220	Musashino-Shi
Japan	Local Institution - 0180	Nagoya-Shi
Japan	Local Institution - 0181	Nagoya-Shi	Aichi
Japan	Local Institution - 0178	Osaka-shi
Japan	Local Institution - 0184	Setagaya-Ku	Tokyo
Japan	Local Institution - 0227	Toride-Shi
Japan	Local Institution - 0189	Toyonaka-Shi
Korea, Republic of	Local Institution - 0110	Gwangjingu
Korea, Republic of	Local Institution - 0050	Incheon
Korea, Republic of	Local Institution - 0114	Junggu
Korea, Republic of	Local Institution - 0117	Songpa-gu	Seoul
Netherlands	Local Institution - 0099	's-Hertogenbosch	NB
Netherlands	Local Institution - 0124	Amsterdam	NH
Singapore	Local Institution - 0091	Singapore
Spain	Local Institution - 0096	Barcelona
Spain	Local Institution - 0158	Barcelona	B
Spain	Local Institution - 0171	Barcelona
Spain	Local Institution - 0172	Barcelona
Spain	Local Institution - 0054	Sant Cugat Del Vallès	CT
Sweden	Local Institution - 0160	Huddinge
Sweden	Local Institution - 0167	Malmo	M
Sweden	Local Institution - 0138	Uppsala	Uppsala Lan
United Kingdom	Local Institution - 0127	Bristol
United Kingdom	Local Institution - 0121	Enfield	LND
United Kingdom	Local Institution - 0090	Guildford	SRY
United Kingdom	Local Institution - 0089	Leatherhead	SRY
United Kingdom	Local Institution - 0100	London	LND
United Kingdom	Local Institution - 0103	Winchester	HAM
United States	Neurological Associates of Albany, P.C.	Albany	New York
United States	Neurology of Central Florida	Altamonte Springs	Florida
United States	Local Institution - 0157	Amherst	New York
United States	JEM Research Institute	Atlantis	Florida
United States	Senior Adults Specialty Research	Austin	Texas
United States	Local Institution - 0155	Beachwood	Ohio
United States	Gadolin Research	Beaumont	Texas
United States	Local Institution - 0228	Boca Raton	Florida
United States	Boston Clinical Trials	Boston	Massachusetts
United States	Local Institution - 0224	Bradenton	Florida
United States	Boston Neuropsychiatry	Braintree	Massachusetts
United States	MD First Research - Chandler	Chandler	Arizona
United States	Great Lakes Clinical Trials	Chicago	Illinois
United States	Local Institution - 0214	Chicago	Illinois
United States	K2 Medical Research - Winter Garden	Clermont	Florida
United States	Columbus Memory Center	Columbus	Georgia
United States	Neurology Clinic, P.C. - Germantown Park Location	Cordova	Tennessee
United States	Kerwin Research Center and Memory Care	Dallas	Texas
United States	Neurology Consultants of Dallas	Dallas	Texas
United States	Associated Neurologists, P.C. - Danbury Office	Danbury	Connecticut
United States	Local Institution - 0215	Dayton	Ohio
United States	Arrow Clinical Trials	Daytona Beach	Florida
United States	Rhode Island Mood & Memory Research Institute	East Providence	Rhode Island
United States	Local Institution - 0161	Elk Grove Village	Illinois
United States	Local Institution - 0164	Encino	California
United States	Local Institution - 0196	Fairfax	Virginia
United States	Local Institution - 0213	Fort Myers	Florida
United States	Local Institution - 0140	Franklin	Tennessee
United States	Local Institution - 0139	Fullerton	California
United States	Gilbert Neurology	Gilbert	Arizona
United States	Local Institution - 0059	Greenacres City	Florida
United States	Great Lakes Clinical Trials d/b/a Flourish Research Gurnee	Gurnee	Illinois
United States	Local Institution - 0198	Hialeah	Florida
United States	Local Institution - 0207	Hialeah	Florida
United States	Local Institution - 0212	Hialeah	Florida
United States	Baylor College of Medicine	Houston	Texas
United States	Memorial Neurological Association - Main Office	Houston	Texas
United States	Local Institution - 0191	Irvine	California
United States	Local Institution - 0187	Jacksonville	Florida
United States	Charter Research - Lady Lake	Lady Lake	Florida
United States	Local Institution - 0146	Lakeland	Florida
United States	Local Institution - 0183	Lakewood	California
United States	Local Institution - 0073	Lomita	California
United States	Local Institution - 0142	Los Alamitos	California
United States	Local Institution - 0065	Madison	Wisconsin
United States	Local Institution - 0192	Maitland	Florida
United States	Neurology & Movement Disorders Healthcare	Maitland	Florida
United States	The Feinstein Institute for Medical Research	Manhasset	New York
United States	Alzheimer's Memory Center	Matthews	North Carolina
United States	Merritt Island Medical Research	Merritt Island	Florida
United States	ActivMed Practices & Research, Inc. - Methuen	Methuen	Massachusetts
United States	Advance Medical Research Center	Miami	Florida
United States	Hope Research Network, LLC	Miami	Florida
United States	IMIC Research	Miami	Florida
United States	Local Institution - 0156	Miami	Florida
United States	Local Institution - 0176	Miami	Florida
United States	Local Institution - 0195	Miami	Florida
United States	Local Institution - 0199	Miami	Florida
United States	Local Institution - 0201	Miami	Florida
United States	Local Institution - 0203	Miami	Florida
United States	Local Institution - 0206	Miami	Florida
United States	Local Institution - 0208	Miami	Florida
United States	Local Institution - 0211	Miami	Florida
United States	Local Institution - 0225	Miami	Florida
United States	Miami Jewish Health Systems	Miami	Florida
United States	Optimus U, Inc.	Miami	Florida
United States	Premier Clinical Research Institute - Miami	Miami	Florida
United States	Project 4 Research	Miami	Florida
United States	Vitae Research Center	Miami	Florida
United States	Local Institution - 0197	Miami Springs	Florida
United States	Neurovations	Napa	California
United States	Local Institution - 0217	Naples	Florida
United States	Local Institution - 0222	Nashville	Tennessee
United States	Hasbani Neurology	New Haven	Connecticut
United States	Local Institution - 0148	New Haven	Connecticut
United States	Suncoast Clinical Research	New Port Richey	Florida
United States	Columbia University Medical Center - The Neurological Institute of New York	New York	New York
United States	Icahn School of Medicine at Mount Sinai (ISMMS) - Alzheimer's Disease Research Center	New York	New York
United States	Local Institution - 0205	New York	New York
United States	Boston Center for Memory	Newton	Massachusetts
United States	Local Institution - 0216	North Canton	Ohio
United States	Renstar Medical Research	Ocala	Florida
United States	Headlands Research - Orlando	Orlando	Florida
United States	Local Institution - 0200	Orlando	Florida
United States	Local Institution - 0202	Orlando	Florida
United States	Local Institution - 0219	Orlando	Florida
United States	Local Institution - 0150	Ozark	Missouri
United States	Local Institution - 0145	Park Ridge	Illinois
United States	Xenoscience Inc. - 21st Century Neurology	Phoenix	Arizona
United States	Office of Donald S. Marks, M.D., P.C.	Plymouth	Massachusetts
United States	Keystone Clinical Studies, LLC	Plymouth Meeting	Pennsylvania
United States	Local Institution - 0210	Port Orange	Florida
United States	ActivMed Practices & Research, Inc. - Portsmouth	Portsmouth	New Hampshire
United States	Princeton Medical Institute	Princeton	New Jersey
United States	Local Institution - 0163	Providence	Rhode Island
United States	Local Institution - 0168	Richmond	Virginia
United States	Be Well MD	Round Rock	Texas
United States	Local Institution - 0209	Sacramento	California
United States	Local Institution - 0169	Saint Louis	Missouri
United States	UCSF Medical Center- Mission Bay	San Francisco	California
United States	Local Institution - 0137	Santa Ana	California
United States	Local Institution - 0204	Sarasota	Florida
United States	Imaging Endpoints LLC	Scottsdale	Arizona
United States	Perseverance Research Center (PRC)	Scottsdale	Arizona
United States	California Neuroscience Research Medical Group, Inc (CNR)	Sherman Oaks	California
United States	Southern Illinois University School of Medicine - SIU Neurology Clinic	Springfield	Illinois
United States	Local Institution - 0153	Stamford	Connecticut
United States	Alzheimer's Research and Treatment Center Stuart	Stuart	Florida
United States	Local Institution - 0136	Stuart	Florida
United States	Axiom Brain Health	Tampa	Florida
United States	Baycare Clinical Research, LLC	Tampa	Florida
United States	Johnnie B. Byrd, Sr. Alzheimer's Foundation, Inc	Tampa	Florida
United States	Advanced Memory Research Institute of NJ	Toms River	New Jersey
United States	Center for Neurosciences - Tucson	Tucson	Arizona
United States	The Banner Alzheimer's Institute - Tucson	Tucson	Arizona
United States	Local Institution - 0194	Viera	Florida
United States	Adams Clinical Trials, LLC	Watertown	Massachusetts
United States	Alzheimer's Research and Treatment Center - Wellington Location	Wellington	Florida
United States	Local Institution - 0149	West Palm Beach	Florida
United States	Local Institution - 0223	West Palm Beach	Florida
United States	Waypoint Research LLC	Windermere	Florida
United States	Charter Research - Winter Park	Winter Park	Florida
United States	Conquest Research LLC	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Japan,  Korea, Republic of,  Netherlands,  Singapore,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score		At week 76
Secondary	Mean change from baseline in brain tau deposition as measured by tau positron emission tomography (PET)		At week 76
Secondary	Mean change from baseline in integrated Alzheimer's Disease Rating Scale (iADRS) score		At week 76
Secondary	Mean change from baseline in Alzheimer's Disease Assessment Scale-Cognitive subscale (ADASCog14) score		At week 76
Secondary	Mean change from baseline in Alzheimer's Disease Cooperative Study-instrumental Activities of Daily Living scale (ADCS-iADL) score		At week 76
Secondary	Mean change from baseline in Mini Mental State Examination (MMSE) score		At week 76

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting