Alzheimer Disease, Early Onset Clinical Trial
— TargetTau-1Official 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)
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.
| 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. |
| 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 - 0074 | Brussel | BRU |
| 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 - 0064 | Kelowna | British Columbia |
| Canada | Local Institution - 0030 | Montreal | Quebec |
| Canada | Local Institution - 0075 | Montreal | Quebec |
| Canada | Local Institution - 0112 | Ottawa | Ontario |
| Canada | Local Institution - 0162 | Peterborough | Ontario |
| Canada | Local Institution - 0053 | Quebec | |
| Canada | Local Institution - 0044 | Toronto | Ontario |
| Canada | Local Institution - 0047 | Toronto | Ontario |
| Canada | Local Institution - 0109 | Toronto | Ontario |
| Canada | Local Institution - 0049 | West Vancouver | British Columbia |
| Denmark | Local Institution - 0072 | Aarhus N | Aarhus |
| Denmark | Local Institution - 0085 | Copenhagen | |
| Denmark | Local Institution - 0166 | Esbjerg | |
| France | Local Institution - 0108 | Angers | |
| France | Local Institution - 0066 | Limoges cedex | |
| France | Local Institution - 0086 | Nantes | |
| France | Local Institution - 0067 | Paris | |
| France | Local Institution - 0084 | Rouen | |
| France | Local Institution - 0131 | Toulouse | |
| France | Local Institution - 0088 | Villeurbanne | |
| Japan | Local Institution - 0185 | Bunkyo-Ku | |
| Japan | Local Institution - 0188 | Kasukabe-Shi | |
| Japan | Local Institution - 0179 | Kodaira-Shi | |
| Japan | Local Institution - 0186 | Kurashiki-Shi | |
| Japan | Local Institution - 0180 | Nagoya-Shi | |
| Japan | Local Institution - 0181 | Nagoya-Shi | |
| Japan | Local Institution - 0178 | Osaka-shi | |
| Japan | Local Institution - 0184 | Setagaya-Ku | |
| 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 | |
| Netherlands | Local Institution - 0124 | Amsterdam | NH |
| Netherlands | Local Institution - 0126 | Breda | North Brabant |
| Netherlands | Local Institution - 0165 | Haarlem | NH |
| Netherlands | Local Institution - 0177 | Zwolle | OV |
| Poland | Local Institution - 0083 | Poznan | |
| Poland | Local Institution - 0079 | Pruszkow | MZ |
| Poland | Local Institution - 0007 | Szczecin | |
| Poland | Local Institution - 0055 | Warszawa | MZ |
| Singapore | Local Institution - 0091 | Singapore | |
| Spain | Local Institution - 0036 | Barcelona | B |
| Spain | Local Institution - 0096 | Barcelona | |
| Spain | Local Institution - 0158 | Barcelona | B |
| Spain | Local Institution - 0171 | Barcelona | |
| Spain | Local Institution - 0172 | Barcelona | |
| Spain | Local Institution - 0063 | Madrid | M |
| Spain | Local Institution - 0006 | Pamplona | |
| Spain | Local Institution - 0010 | Pozuelo De Alarcon | M |
| Spain | Local Institution - 0054 | Sant Cugat Del Vallès | CT |
| Spain | Local Institution - 0004 | Sevilla | |
| Sweden | Local Institution - 0160 | Huddinge | |
| Sweden | Local Institution - 0167 | Malmo | M |
| Sweden | Local Institution - 0138 | Uppsala | Uppsala Lan |
| Sweden | Local Institution - 0173 | Uppsala | |
| 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 - 0070 | London | LND |
| United Kingdom | Local Institution - 0100 | London | LND |
| United Kingdom | Local Institution - 0103 | Winchester | HAM |
| United States | Abington Neurological Associates (ANA) | Abington | Pennsylvania |
| 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 | Boston Clinical Trials | Boston | Massachusetts |
| 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 - 0020 | 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 | 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 | Rocky Mountain Movement Disorder Center | Englewood | Colorado |
| 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 | Baylor College of Medicine | Houston | Texas |
| United States | Memorial Neurological Association - Main Office | Houston | Texas |
| United States | Local Institution - 0187 | Jacksonville | Florida |
| United States | Local Institution - 0152 | La Jolla | California |
| 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 - 0143 | 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 | 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 | Neurovations | Napa | California |
| United States | Hasbani Neurology | New Haven | Connecticut |
| United States | Local Institution - 0148 | New Haven | Connecticut |
| United States | Neurological Associates of Long Island | New Hyde Park | New York |
| 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 - 0095 | New York | New York |
| United States | Boston Center for Memory | Newton | Massachusetts |
| United States | Local Institution - 0144 | Ocala | Florida |
| United States | Headlands Research - Orlando | Orlando | Florida |
| United States | Local Institution - 0150 | Ozark | Missouri |
| United States | Local Institution - 0141 | Palm Beach Gardens | Florida |
| United States | Local Institution - 0145 | Park Ridge | Illinois |
| United States | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
| 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 | 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 | Rhode Island Hospital - Alzheimer's Disease and Memory Disorders Center | Providence | Rhode Island |
| United States | Local Institution - 0168 | Richmond | Virginia |
| United States | Be Well MD | Round Rock | Texas |
| United States | Central Texas Neurology Consultants (CTNC) | Round Rock | Texas |
| 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 | Imaging Endpoints LLC | Scottsdale | Arizona |
| United States | Office of Allan M. Block, MD | Scottsdale | Arizona |
| United States | Local Institution - 0135 | Seal Beach | California |
| 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 | Baycare Clinical Research, LLC | Tampa | Florida |
| United States | First Choice Neurology - Tampa Neurology Associates | 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 | Tucson Neuroscience Research, LLC | Tucson | Arizona |
| United States | Adams Clinical Trials, LLC | Watertown | Massachusetts |
| United States | Alzheimer's Research and Treatment Center - Wellington Location | Wellington | Florida |
| United States | Neurology Specialists of Monmouth County, PA | West Long Branch | New Jersey |
| United States | Local Institution - 0149 | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Australia, Belgium, Canada, Denmark, France, Japan, Korea, Republic of, Netherlands, Poland, Singapore, Spain, Sweden, United Kingdom,
| 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 |
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