Clinical trial NCT06268886: Study to Evaluate the Efficacy, Safety, and Tolerability of an Anti-MTBR Tau Monoclonal Antibody (BMS-986446) in Participants With Early Alzheimer's Disease
Official title: A Randomized, Double-blind, Placebo-controlled, Global Proof-of-concept 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Alzheimer Disease, Early Onset
Keywords: Alzheimer Disease
BMS-986446
Neurodegenerative disease
Dementia
Brain Diseases
Anti-MTBR tau monoclonal antibody
TargetTau-1
Anti-tau therapy
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2024-02-20
Enrollment: 310
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in brain tau deposition as measured by tau positron emission tomography (PET)
timeFrame: At week 76
Secondary outcomes:
measure: Change from baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score
timeFrame: At week 76
measure: Change from baseline in integrated Alzheimer's Disease Rating Scale (iADRS) score
timeFrame: At week 76
measure: Change from baseline in Alzheimer's Disease Assessment Scale-Cognitive subscale (ADASCog14) score
timeFrame: At week 76
measure: Change from baseline in Alzheimer's Disease Cooperative Study-instrumental Activities of Daily Living scale (ADCS-iADL) score
timeFrame: At week 76
measure: Change from baseline in Mini Mental State Examination (MMSE) score
timeFrame: At week 76
Other outcomes:
Locations:
city: Chandler
country: United States
facility: MD First Research - Chandler
state: Arizona
city: Gilbert
country: United States
facility: Gilbert Neurology
state: Arizona
city: Phoenix
country: United States
facility: Xenoscience Inc. - 21st Century Neurology
state: Arizona
city: Scottsdale
country: United States
facility: Perseverance Research Center (PRC)
state: Arizona
city: Scottsdale
country: United States
facility: Imaging Endpoints LLC
state: Arizona
city: Tucson
country: United States
facility: Center for Neurosciences - Tucson
state: Arizona
city: Tucson
country: United States
facility: The Banner Alzheimer's Institute - Tucson
state: Arizona
city: Encino
country: United States
facility: Pharmacology Research Institute (PRI) - Encino
state: California
city: Fullerton
country: United States
facility: Neurology Center of North Orange County
state: California
city: Irvine
country: United States
facility: Irvine Center for Clinical Research
state: California
city: Lomita
country: United States
facility: Local Institution - 0073
state: California
city: Long Beach
country: United States
facility: Healthy Brain Clinic
state: California
city: Los Alamitos
country: United States
facility: Local Institution - 0142
state: California
city: Napa
country: United States
facility: Local Institution - 0037
state: California
city: Sacramento
country: United States
facility: University of California Davis (UC Davis) - Alzheimer's Disease Center (ADC) - Sacramento
state: California
city: San Francisco
country: United States
facility: UCSF Medical Center at Mission Bay
state: California
city: Santa Ana
country: United States
facility: Local Institution - 0183
state: California
city: Santa Ana
country: United States
facility: Syrentis Clinical Research
state: California
city: Sherman Oaks
country: United States
facility: California Neuroscience Research Medical Group, Inc (CNR)
state: California
city: Danbury
country: United States
facility: Local Institution - 0106
state: Connecticut
city: New Haven
country: United States
facility: Local Institution - 0229
state: Connecticut
city: New Haven
country: United States
facility: Yale School Of Medicine
state: Connecticut
city: New Haven
country: United States
facility: Hasbani Neurology
state: Connecticut
city: Stamford
country: United States
facility: New England Institute for Neurology and Headache (NEINH)
state: Connecticut
city: Altamonte Springs
country: United States
facility: Neurology of Central Florida
state: Florida
city: Atlantis
country: United States
facility: JEM Research Institute
state: Florida
city: Boca Raton
country: United States
facility: Neurology Offices of South Florida - Boca Raton
state: Florida
city: Boca Raton
country: United States
facility: Local Institution - 0251
state: Florida
city: Boca Raton
country: United States
facility: SFM Clinical Research, LLC
state: Florida
city: Bradenton
country: United States
facility: Bradenton Research Center, Inc.
state: Florida
city: Clermont
country: United States
facility: K2 Medical Research - Winter Garden
state: Florida
city: Daytona Beach
country: United States
facility: Arrow Clinical Trials
state: Florida
city: Fort Myers
country: United States
facility: Neuropsychiatric Research Center of Southwest Florida
state: Florida
city: Greenacres City
country: United States
facility: Finlay Medical Research (FMR) Corporation - Greenacres
state: Florida
city: Hialeah
country: United States
facility: Indago Research and Health Center, Inc.
state: Florida
city: Hialeah
country: United States
facility: Health Care Family Rehab & Research Center
state: Florida
city: Hialeah
country: United States
facility: Local Institution - 0198
state: Florida
city: Lady Lake
country: United States
facility: Charter Research - Lady Lake
state: Florida
city: Lake Mary
country: United States
facility: Local Institution - 0246
state: Florida
city: Lakeland
country: United States
facility: Accel Research Sites - Lakeland Clinical Research Unit
state: Florida
city: Maitland
country: United States
facility: ClinCloud LLC
state: Florida
city: Maitland
country: United States
facility: Neurology & Movement Disorders Healthcare
state: Florida
city: Merritt Island
country: United States
facility: Merritt Island Medical Research
state: Florida
city: Miami Springs
country: United States
facility: South Florida Research Phase I-IV, Inc
state: Florida
city: Miami
country: United States
facility: Homestead Associates in Research, Inc.
state: Florida
city: Miami
country: United States
facility: Premier Clinical Research Institute - Miami
state: Florida
city: Miami
country: United States
facility: Local Institution - 0013
state: Florida
city: Miami
country: United States
facility: Project 4 Research
state: Florida
city: Miami
country: United States
facility: Finlay Medical Research Corp.
state: Florida
city: Miami
country: United States
facility: CCM Clinical Research Group
state: Florida
city: Miami
country: United States
facility: Vitae Research Center
state: Florida
city: Miami
country: United States
facility: Advance Medical Research Center
state: Florida
city: Miami
country: United States
facility: Advanced Clinical Research Network, Corp
state: Florida
city: Miami
country: United States
facility: Miami Jewish Health Systems
state: Florida
city: Miami
country: United States
facility: Local Institution - 0199
state: Florida
city: Miami
country: United States
facility: Global Life Research LLC
state: Florida
city: Miami
country: United States
facility: Local Institution - 0201
state: Florida
city: Miami
country: United States
facility: Ivetmar Medical Group LLC
state: Florida
city: Miami
country: United States
facility: Hope Research Network, LLC
state: Florida
city: Miami
country: United States
facility: EZY Medical Research
state: Florida
city: Miami
country: United States
facility: First Choice Neurology - Medical Arts Neurology
state: Florida
city: Miami
country: United States
facility: IMIC Research
state: Florida
city: Miami
country: United States
facility: Miami Dade Medical Research Institute
state: Florida
city: Naples
country: United States
facility: Aqualane Clinical Research
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Orlando
country: United States
facility: K2 Medical Research - South Orlando
state: Florida
city: Orlando
country: United States
facility: Local Institution - 0219
state: Florida
city: Orlando
country: United States
facility: Headlands Research - Orlando
state: Florida
city: Orlando
country: United States
facility: Brain, Spine and Pain Institute of Lake Nona
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Sarasota
country: United States
facility: Intercoastal Medical Group, Inc. - Hyde Park East & West
state: Florida
city: Stuart
country: United States
facility: Alzheimer's Research and Treatment Center Stuart
state: Florida
city: Stuart
country: United States
facility: Brain Matters Research - Stuart
state: Florida
city: Tampa
country: United States
facility: K2 Medical Research - Tampa
state: Florida
city: Tampa
country: United States
facility: Baycare Clinical Research, LLC
state: Florida
city: Tampa
country: United States
facility: Axiom Brain Health
state: Florida
city: Tampa
country: United States
facility: Johnnie B. Byrd, Sr. Alzheimer's Foundation, Inc
state: Florida
city: Viera
country: United States
facility: Clincloud Clinical Research
state: Florida
city: Wellington
country: United States
facility: Alzheimer's Research and Treatment Center - Wellington Location
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Neurology Premiere Research Institute
state: Florida
city: West Palm Beach
country: United States
facility: Quantum Laboratories, Inc - West Palm Beach Office
state: Florida
city: Windermere
country: United States
facility: Waypoint Research LLC
state: Florida
city: Winter Park
country: United States
facility: Conquest Research LLC
state: Florida
city: Winter Park
country: United States
facility: Charter Research - Winter Park
state: Florida
city: Atlanta
country: United States
facility: Local Institution - 0241
state: Georgia
city: Columbus
country: United States
facility: Columbus Memory Center
state: Georgia
city: Chicago
country: United States
facility: Cognition Health - Chicago
state: Illinois
city: Chicago
country: United States
facility: Great Lakes Clinical Trials
state: Illinois
city: Elk Grove Village
country: United States
facility: Alexian Brothers Neurosciences Institute
state: Illinois
city: Gurnee
country: United States
facility: Local Institution - 0003
state: Illinois
city: Park Ridge
country: United States
facility: Advocate Lutheran General Hospital
state: Illinois
city: Springfield
country: United States
facility: Local Institution - 0081
state: Illinois
city: Boston
country: United States
facility: Copley Clinical
state: Massachusetts
city: Boston
country: United States
facility: Local Institution - 0182
state: Massachusetts
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Braintree
country: United States
facility: Alzheimer Disease Center
state: Massachusetts
city: Foxboro
country: United States
facility: Neurology Center of New England, PC
state: Massachusetts
city: Methuen
country: United States
facility: ActivMed Practices & Research, Inc. - Methuen
state: Massachusetts
city: Newton
country: United States
facility: Boston Center for Memory
state: Massachusetts
city: Plymouth
country: United States
facility: Office of Donald S. Marks, M.D., P.C.
state: Massachusetts
city: Watertown
country: United States
facility: Adams Clinical Trials, LLC
state: Massachusetts
city: Saint Louis
country: United States
facility: Local Institution - 0169
state: Missouri
city: Portsmouth
country: United States
facility: Local Institution - 0119
state: New Hampshire
city: Princeton
country: United States
facility: Princeton Medical Institute
state: New Jersey
city: Toms River
country: United States
facility: Advanced Memory Research Institute of NJ
state: New Jersey
city: Albany
country: United States
facility: Neurological Associates of Albany, P.C.
state: New York
city: Amherst
country: United States
facility: Dent Neurologic Institute - Amherst
state: New York
city: Manhasset
country: United States
facility: The Feinstein Institute for Medical Research
state: New York
city: New York
country: United States
facility: Berman Clinical
state: New York
city: New York
country: United States
facility: Berman Clinical
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai (ISMMS) - Alzheimer's Disease Research Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center - The Neurological Institute of New York
state: New York
city: Matthews
country: United States
facility: Alzheimer's Memory Center
state: North Carolina
city: Dayton
country: United States
facility: Neurology Diagnostics, Inc.
state: Ohio
city: Independence
country: United States
facility: Local Institution - 0155
state: Ohio
city: North Canton
country: United States
facility: Local Institution - 0216
state: Ohio
city: Plymouth Meeting
country: United States
facility: Keystone Clinical Studies, LLC
state: Pennsylvania
city: East Providence
country: United States
facility: Rhode Island Mood & Memory Research Institute
state: Rhode Island
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
city: Cordova
country: United States
facility: Neurology Clinic, P.C. - Germantown Park Location
state: Tennessee
city: Franklin
country: United States
facility: Local Institution - 0140
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: Senior Adults Specialty Research
state: Texas
city: Beaumont
country: United States
facility: Gadolin Research
state: Texas
city: Dallas
country: United States
facility: Kerwin Research Center and Memory Care
state: Texas
city: Dallas
country: United States
facility: Neurology Consultants of Dallas
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Memorial Neurological Association - Main Office
state: Texas
city: Round Rock
country: United States
facility: Be Well MD
state: Texas
city: Charlottesville
country: United States
facility: Local Institution - 0233
state: Virginia
city: Fairfax
country: United States
facility: Re:Cognition Health - Fairfax
state: Virginia
city: Richmond
country: United States
facility: National Clinical Research - Richmond, Inc.
state: Virginia
city: Madison
country: United States
facility: Local Institution - 0065
state: Wisconsin
city: East Gosford
country: Australia
facility: Central Coast Neuroscience Research - East Gosford
state: New South Wales
city: Macquarie Park
country: Australia
facility: KaRa Institute of Neurological Disease Pty Ltd
state: New South Wales
city: Griffith University
country: Australia
facility: Griffith University - Clinical Trial Unit - Gold Coast Campus
state: Queensland
city: Carlton North
country: Australia
facility: NeuroCentrix
state: Victoria
city: Ivanhoe
country: Australia
facility: Austin Health - Heidelberg Repatriation Hospital
state: Victoria
city: Malvern
country: Australia
facility: HammondCare
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Parkville
country: Australia
facility: Local Institution - 0147
state: Victoria
city: Nedlands
country: Australia
facility: Alzheimer's Research Australia
state: Western Australia
city: Anderlecht
country: Belgium
facility: Local Institution - 0122
state: Brussels
city: Antwerpen
country: Belgium
facility: Antwerp University Hospital
state: Brussel
city: Kortrijk
country: Belgium
facility: AZ Groeninge - Campus Kennedylaan
state: VWV
city: Liege
country: Belgium
facility: Local Institution - 0078
state: WLG
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Leuven
country: Belgium
facility: UZ Leuven
city: Ottawa
country: Canada
facility: Ottawa Memory Clinic
state: Ontario
city: Toronto
country: Canada
facility: Toronto Memory Program
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Toronto
country: Canada
facility: The Rotman Research Institute at Baycrest
state: Ontario
city: Greenfield Park
country: Canada
facility: MoCA Clinic & Institute (Memory Clinic)
state: Quebec
city: Montreal
country: Canada
facility: Local Institution - 0193
state: Quebec
city: Montreal
country: Canada
facility: Genge Partners Inc
state: Quebec
city: Montreal
country: Canada
facility: Local Institution - 0075
state: Quebec
city: Quebec
country: Canada
facility: Alpha Recherche Clinique
city: Nagoya-Shi
country: Japan
facility: Local Institution - 0181
state: Aichi
city: Toride-Shi
country: Japan
facility: Memory Clinic Toride
state: Ibaraki
city: Kurashiki-Shi
country: Japan
facility: Katayama Medical Clinic
state: Okayama
city: Hirakata-Shi
country: Japan
facility: Hatsuta Neurology Clinic
state: Osaka
city: Osaka-shi
country: Japan
facility: Tominaga Clinic
state: Osaka
city: Bunkyo-Ku
country: Japan
facility: Memory Clinic Ochanomizu
state: Tokyo
city: Hachioji-Shi
country: Japan
facility: P-One Clinic
state: Tokyo
city: Setagaya-Ku
country: Japan
facility: Kanto Central Hospital of the Mutual Aid Association of Public School Teachers
state: Tokyo
city: Chuo-Ku
country: Japan
facility: Tokyo Asubo Clinic
city: Himeji-shi
country: Japan
facility: Hyogo Prefectural Harima Himeji General Medical Center
city: Kasukabe-Shi
country: Japan
facility: Local Institution - 0188
city: Kodaira-Shi
country: Japan
facility: National Center Of Neurology And Psychiatry
city: Musashimurayama-Shi
country: Japan
facility: Musashimurayama Hospital
city: Musashino-shi
country: Japan
facility: Japanese Red Cross Musashino Hospital
city: Nagoya-Shi
country: Japan
facility: Meitetsu Hospital
city: Obu
country: Japan
facility: National Center for Geriatrics and Gerontology (NCGG)
city: Osaka-shi
country: Japan
facility: Osaka Metropolitan University Hospital
city: Tachikawa-Shi
country: Japan
facility: Local Institution - 0240
city: Takatsuki-Shi
country: Japan
facility: Takatsuki General Hospital
city: Toyonaka-Shi
country: Japan
facility: MI Clinic
city: Songpa-gu
country: Korea, Republic of
facility: Local Institution - 0117
state: Seoul
city: Gwangjingu
country: Korea, Republic of
facility: Konkuk University Medical Center (KUMC) - Dementia Clinic
city: Incheon
country: Korea, Republic of
facility: Gachon University - Gil Medical Center
city: Junggu
country: Korea, Republic of
facility: Local Institution - 0114
city: Singapore
country: Singapore
facility: National University of Singapore's Yong Loo Lin School of Medicine (NUS Medicine)
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona (Hospital Clinic i Provincial) - Barnaclinic S.A.
state: B
city: Sant Cugat Del Vallès
country: Spain
facility: Hospital Universitari General de Catalunya
state: CT
city: Lleida
country: Spain
facility: Hospital Universitario Santa Maria de Lerida
state: L
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Malmo
country: Sweden
facility: Skanes Universitetssjukhus - Malmo (Universitetssjukhuset MAS) - Minneskliniken
state: M
city: Uppsala
country: Sweden
facility: Local Institution - 0138
state: Uppsala Lan
city: Huddinge
country: Sweden
facility: Local Institution - 0160
city: Birmingham
country: United Kingdom
facility: Local Institution - 0244
state: BIR
city: Bristol
country: United Kingdom
facility: Local Institution - 0245
state: BST
city: Southampton
country: United Kingdom
facility: Local Institution - 0237
state: Hampshire
city: Southampton
country: United Kingdom
facility: Local Institution - 0230
state: HAM
city: Winchester
country: United Kingdom
facility: Local Institution - 0103
state: HAM
city: Enfield
country: United Kingdom
facility: Local Institution - 0121
state: LND
city: London
country: United Kingdom
facility: St Pancras Clinical Research (SPCR)
state: LND
city: London
country: United Kingdom
facility: Local Institution - 0100
state: LND
city: Bath
country: United Kingdom
facility: Local Institution - 0247
state: SOM
city: Guildford
country: United Kingdom
facility: Local Institution - 0090
state: SRY
city: Chertsey
country: United Kingdom
facility: Surrey and Borders NHS Foundation Trust Headquarters
state: Surrey
city: Bristol
country: United Kingdom
facility: Local Institution - 0127
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: