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A Donanemab (LY3002813) Prevention Study in Participants With Alzheimer's Disease (TRAILBLAZER-ALZ 3)

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05026866
Collaborator
(none)
3,300
Enrollment
219
Locations
2
Arms
74.4
Anticipated Duration (Months)
15.1
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of this study is to evaluate the safety and efficacy of donanemab in participants with preclinical Alzheimer's Disease (AD).

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
3300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Study of Donanemab Versus Placebo in Participants at Risk for Cognitive and Functional Decline of Alzheimer's Disease
Actual Study Start Date :
Aug 27, 2021
Anticipated Primary Completion Date :
Oct 25, 2027
Anticipated Study Completion Date :
Nov 8, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Donanemab

Donanemab administered intravenously (IV)

Drug: Donanemab
Administered intravenously
Other Names:
  • LY3002813

    		•
    Placebo Comparator: Placebo

    Placebo is administered intravenously

    Drug: Placebo
    Administered intravenously

    Outcome Measures

    Primary Outcome Measures

    1. Time to clinical progression as measured by Clinical Dementia Rating - Global Score (CDR-GS) [Estimated Up to Week 182]

      Time to clinical progression as measured by CDR-GS. CDR is a clinician-rated scale that provides an overall assessment of the participant's stage on the spectrum of AD dementia.

    Secondary Outcome Measures

    1. Change from Baseline in International Shopping List Test (ISLT) [Baseline, Up to Week 182]

      Change from Baseline in clinical progression as measured by ISLT in participants with preclinical AD.

    2. Change from Baseline in Continuous Paired Associate Learning (CPAL) [Baseline, Up to Week 182]

      Change from Baseline in clinical progression as measured by CPAL in participants with preclinical AD.

    3. Change from Baseline in International Daily Symbol Substitution Test-Medicines (iDSSTm) [Baseline, Up to Week 182]

      Change from Baseline in clinical progression as measured by iDSSTm in participants with preclinical AD.

    4. Change from Baseline in Category Fluency [Baseline, Up to Week 182]

      Change from Baseline in clinical progression as measured by Category Fluency in participants with preclinical AD.

    5. Change from Baseline in Face Name Association Test (FNAME) [Baseline, Up to Week 182]

      Change from Baseline in clinical progression as measured by FNAME in participants with preclinical AD.

    6. Change from Baseline in Behavioral Pattern Separation-Object test (BPS-O) [Baseline, Up to Week 182]

      Change from Baseline in clinical progression as measured by BPS-O in participants with preclinical AD.

    7. Change from Baseline in Cogstate Brief Battery (CBB) [Baseline, Up to Week 182]

      Change from Baseline in clinical progression as measured by CBB in participants with preclinical AD.

    8. Change from Baseline in CDR-Sum of Boxes (CDR-SB) [Baseline, Up Week 32]

      Change from Baseline in clinical progression as measured by CDR-SB in participants with preclinical AD.

    9. Change from Baseline in Cognitive Function Index (CFI) [Baseline, Up to Week 182]

      Change from Baseline in clinical progression as measured by CFI in participants with preclinical AD.

    10. Change from Baseline in Montreal Cognitive Assessment (MoCA) score [Baseline, Up to Week 182]

      Change from Baseline in clinical progression as measured by MoCA score in participants with preclinical AD.

    11. Pharmacokinetics (PK): Average Serum Donanemab Concentration at Steady State [Baseline through Week 76]

      PK: Average Serum Donanemab Concentration at Steady State

    12. Percentage of Participants with Treatment-emergent Anti-Drug Antibody (ADAs) [Baseline through Week 16]

      Percentage of Participants with Treatment-emergent Anti-Drug Antibody (ADAs)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • A Telephone Interview for Cognitive Status - modified (TICS-M) score reflective of intact cognitive functioning.

    • Has a phosphorylated tau (P-tau) result consistent with the presence of amyloid and early-tau pathology.

    • Has a reliable study partner and backup study partner familiar with overall function and behavior, such as day-to-day activities and cognitive abilities.

    • Have adequate literacy, vision, and hearing for neuropsychological testing at screening.

    • Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

    • Female participants include those who are infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as Mullerian agenesis; or post menopausal (women 55 or older not on hormone therapy and had at least 12 months of spontaneous amenorrhea; or with a diagnosis of menopause prior to starting hormone replacement therapy.

    Exclusion Criteria:

    • Mild cognitive impairment or dementia, or significant other neurodegenerative disease that can affect cognition.

    • Current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease that could interfere with the analysis of the study or a life expectancy of approximately ≤5 years.

    • History of cancer with high risk of recurrence and preventing completion of the trial.

    • History of clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions (including but not limited to erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, and/or exfoliative dermatitis).

    • Have any clinically important abnormality at screening on magnetic resonance imaging (MRI) or clinical laboratory test results that could be detrimental to the participant or study integrity.

    • Have any contraindications for MRI, including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker.

    • Have a centrally read MRI demonstrating presence of amyloid-related imaging abnormalities (ARIA-E), >4 cerebral microhemorrhages, more than 1 area of superficial siderosis, any macrohemorrhage or severe white matter disease at screening.

    • Have had prior treatment with a passive anti-amyloid immunotherapy <5 half-lives prior to randomization.

    • Have received active immunization against amyloid beta (Aβ) in any other study.

    • Have received active immunization against Aβ in any other study.

    • Current or previous use of prescription medications used as treatment for mild cognitive impairment (MCI) or AD.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Parkway Medical Center Birmingham Alabama United States 35215
    2 Tilda Research - USAL 45 Homewood Alabama United States 35209
    3 Rehabilitation & Neurological Services Huntsville Alabama United States 35805
    4 Care Access - 801 South Power Road, Mesa Mesa Arizona United States 85206
    5 Banner Alzheimer's Institute Phoenix Arizona United States 85006
    6 Barrow Neurological Institute Phoenix Arizona United States 85013
    7 Banner Alzheimer's Institute Tucson Tucson Arizona United States 85718
    8 Center for Neurosciences Tucson Arizona United States 85718
    9 Option Care - Bakersfield Bakersfield California United States 93313
    10 Care Access - Berkeley Berkeley California United States 94705
    11 Care Access - Beverly Hills Beverly Hills California United States 90212
    12 Velocity Clinical Research, Chula Vista Chula Vista California United States 91911
    13 Valley Clinical Trials, Inc. Covina California United States 91723
    14 Neurology Center of North Orange County Fullerton California United States 92835
    15 Care Access - Gilroy Gilroy California United States 95020
    16 Marvel Clinical Research Huntington Beach California United States 92647
    17 Care Access Research - Huntington Beach Huntington Beach California United States 92648
    18 Tilda Research Irvine California United States 92604
    19 Irvine Clinical Research Irvine California United States 92614
    20 Option Care - Irvine Irvine California United States 92618
    21 Kaizen Brain Center La Jolla California United States 92037
    22 Velocity Clinical Research, San Diego La Mesa California United States 91942
    23 Cedars-Sinai Medical Center Los Angeles California United States 90048
    24 Neurovations Napa California United States 94558
    25 Care Access - Newport Beach Newport Beach California United States 92660
    26 Valley Clinical Trials, Inc. Northridge California United States 91325
    27 National Research Institute Panorama City California United States 91402
    28 Inland Psychiatric Medical Group Redlands California United States 92373
    29 Anderson Clinical Research Redlands California United States 92374
    30 Artemis Institute for Clinical Research Riverside California United States 92503
    31 Option Care - Riverside Riverside California United States 92507
    32 Clinical Trials Research Sacramento California United States 95821
    33 Artemis Institute for Clinical Research San Diego California United States 92103
    34 Pacific Research Network San Diego California United States 92103
    35 Ray Dolby Brain Health Center San Francisco California United States 94114
    36 Care Access - Los Gatos San Jose California United States 95124
    37 Syrentis Clinical Research Santa Ana California United States 92705
    38 Care Access - Santa Clarita Santa Clarita California United States 91321
    39 Option Care - Los Angeles South Santa Fe Springs California United States 90670
    40 Providence Medical Foundation Santa Rosa California United States 95403
    41 Mazur, Statner, Dutta, Nathan Thousand Oaks California United States 91360
    42 Infect Disease Doctors Med Grp Walnut Creek California United States 94598
    43 Care Access - Aurora Aurora Colorado United States 80012
    44 Mountain Neurological Research Center Basalt Colorado United States 81621
    45 Colorado Neurological Research Center, PC Denver Colorado United States 80210
    46 Invicro New Haven Connecticut United States 06510
    47 JEM Research Institute Atlantis Florida United States 33462
    48 VIN-Julie Schwartzbard Aventura Florida United States 33180
    49 Neurology Offices of South Florida Boca Raton Florida United States 33428
    50 Excel Medical Clinical Trials Boca Raton Florida United States 33434
    51 SFM Clinical Research Boca Raton Florida United States 33487
    52 Bradenton Research Center, Inc. Bradenton Florida United States 34205
    53 Clinical Research of West Florida, Inc. (Clearwater) Clearwater Florida United States 33765
    54 Care Access - Daytona Beach Daytona Beach Florida United States 32114
    55 Care Access - Delray Beach Delray Beach Florida United States 33484
    56 Finlay Medical Research Greenacres City Florida United States 33467
    57 Indago Research & Health Center, Inc Hialeah Florida United States 33012
    58 Infinity Clinical Research, LLC Hollywood Florida United States 33024
    59 Jacksonville Center for Clinical Research Jacksonville Florida United States 32216
    60 Optum Infusion - Jacksonville Jacksonville Florida United States 32257
    61 Care Access - Guava Street Lady Lake Florida United States 32159
    62 Charter Research Lady Lake Florida United States 32159
    63 ClinCloud - Maitland Maitland Florida United States 32751
    64 K2 Medical Research Maitland Florida United States 32751
    65 ClinCloud - Viera Melbourne Florida United States 32940
    66 Merritt Island Medical Research, LLC Merritt Island Florida United States 32952
    67 San Marcus Research Clinic, Inc. Miami Lakes Florida United States 33014
    68 South Florida Research Phase I-IV Miami Springs Florida United States 33166
    69 Optimus U Corporation Miami Florida United States 33125
    70 Finlay Medical Research Miami Florida United States 33126
    71 VIN-Andrew Lerman Miami Florida United States 33133
    72 Brainstorm Research Miami Florida United States 33176
    73 VIN-Victor Faradji Miami Florida United States 33176
    74 Adult Medicine of Lake County Mount Dora Florida United States 32757
    75 Suncoast Clinical Research, Inc. New Port Richey Florida United States 34652
    76 Renstar Medical Research Ocala Florida United States 34470
    77 Headlands Research Orlando Orlando Florida United States 32819
    78 IMIC, Inc. Palmetto Bay Florida United States 33157
    79 Pines Care Research Center Pembroke Pines Florida United States 33024
    80 VIN- Margarita Almeida El-Ramey Pembroke Pines Florida United States 33026
    81 Emerald Coast Neurology - Airport Boulevard Pensacola Florida United States 32504
    82 Progressive Medical Research Port Orange Florida United States 32127
    83 Care Access - Pebble Beach Boulevard, Tampa Sun City Florida United States 33573
    84 Care Access - Tamarac Tamarac Florida United States 33321
    85 Clinical Research of West Florida Tampa Florida United States 33606
    86 Stedman Clinical Trials Tampa Florida United States 33613
    87 Olympian Clinical Research Tampa Florida United States 33614
    88 Vicis Clinical Research Tampa Florida United States 33615
    89 Accel Research Sites - Tampa Clinical Research Unit Tampa Florida United States 33634
    90 Coram CVS/Specialty Infusion Services - Tampa Tampa Florida United States 33634
    91 Palm Beach Research Center West Palm Beach Florida United States 33409
    92 Conquest Research Winter Park Florida United States 32789
    93 Charter Research - Winter Park Winter Park Florida United States 32792
    94 Masters of Clinical Research Augusta Georgia United States 30909
    95 iResearch Atlanta Decatur Georgia United States 30030
    96 Center for Advanced Research & Education Gainesville Georgia United States 30501
    97 SKY Clinical Research Network Group-Blake Union City Georgia United States 30291
    98 North Georgia Clinical Research Woodstock Georgia United States 30189
    99 Northwest Clinical Trials Boise Idaho United States 83704
    100 IMA Clinical Research - Chicago Chicago Illinois United States 60602
    101 University of Chicago Medical Center Chicago Illinois United States 60637
    102 Great Lakes Clinical Trials - Andersonville Chicago Illinois United States 60640
    103 Uptown Research Institute Chicago Illinois United States 60640
    104 Alexian Brothers Medical Center Elk Grove Village Illinois United States 60007
    105 Care Access - Fairview Heights Fairview Heights Illinois United States 62208
    106 Great Lakes Clinical Trials - Gurnee Gurnee Illinois United States 60031
    107 Option Care - Chicago Itasca Illinois United States 60143
    108 Accellacare - DuPage Lombard Illinois United States 60148
    109 Coram CVS/Specialty Infusion Services - Fort Wayne Fort Wayne Indiana United States 46805
    110 Care Access - Indianapolis Indianapolis Indiana United States 46236
    111 Josephson Wallack Munshower Neurology, PC Indianapolis Indiana United States 46256
    112 Covenant Medical Center Waterloo Iowa United States 50702
    113 College Park Specialty Center Overland Park Kansas United States 66212
    114 Norton Brownsboro Hospital Louisville Kentucky United States 40241
    115 Optum Infusion - Baton Rouge Baton Rouge Louisiana United States 70809
    116 Care Access - Lake Charles Lake Charles Louisiana United States 70601
    117 MD Medical Research Oxon Hill Maryland United States 20745
    118 ActivMed Practices and Research Methuen Massachusetts United States 01844
    119 Boston Center for Memory Newton Massachusetts United States 02459
    120 Care Access - Quincy Quincy Massachusetts United States 02171
    121 MedVadis Research Corporation Waltham Massachusetts United States 02451
    122 Revival Research Institute Sterling Heights Michigan United States 48312
    123 Minneapolis Clinic of Neurology - Burnsville Office Burnsville Minnesota United States 55337
    124 Coram CVS/Specialty Infusion Services - Mendota Heights Mendota Heights Minnesota United States 55120
    125 SKY Clinical Research Network Group - Hall Fayette Mississippi United States 39069
    126 Quinn Healthcare/SKYCRNG Ridgeland Mississippi United States 39157
    127 Citizens Memorial Hospital District Bolivar Missouri United States 65613
    128 Clinical Research Professionals Chesterfield Missouri United States 63005
    129 Saint Luke's Hospital of Kansas City Kansas City Missouri United States 64111
    130 IMA Clinical Research - St. Louis Saint Louis Missouri United States 63117
    131 Coram CVS/Specialty Infusion Services - Henderson Henderson Nevada United States 89014
    132 Las Vegas Medical Research Las Vegas Nevada United States 89113
    133 Amici Clinical Research Hoboken New Jersey United States 07030
    134 Amici Clinical Research LLC Raritan New Jersey United States 08869
    135 The Cognitive and Research Center of New Jersey Springfield New Jersey United States 07081
    136 Albuquerque Neuroscience Inc. Albuquerque New Mexico United States 87109
    137 IMA Clinical Research - Albany Albany New York United States 12205
    138 Neurological Associates Albany Albany New York United States 12208
    139 Prime Global Research Bronx New York United States 10456
    140 Velocity Clinical Research, Syracuse East Syracuse New York United States 13057
    141 IMA Clinical Research - Hartsdale Hartsdale New York United States 10530
    142 IMA Clinical Research New York New York United States 10036
    143 South Shore Neurologic Associates Patchogue New York United States 11772
    144 Richmond Behavioral Associates Staten Island New York United States 10314
    145 Asheville Neurology Specialists Asheville North Carolina United States 28806
    146 Medication Management Greensboro North Carolina United States 27408
    147 Care Access - Hope Mills Hope Mills North Carolina United States 28348
    148 Care Access Research-Kinston Kinston North Carolina United States 28501
    149 Monroe Biomedical Research Monroe North Carolina United States 28112
    150 Carteret Medical Group Morehead City North Carolina United States 28557
    151 Care Access - Raleigh Raleigh North Carolina United States 27607
    152 Accellacare - Winston-Salem Winston-Salem North Carolina United States 27103
    153 NeuroScience Research Center Canton Ohio United States 44718
    154 Wellnow Urgent Care and Research Cincinnati Ohio United States 45215
    155 Neurology Diagnostics, Inc. Dayton Ohio United States 45459
    156 Care Access - Lima Lima Ohio United States 45805
    157 North Star Medical Research Middleburg Heights Ohio United States 44130
    158 Care Access - Youngstown Poland Ohio United States 44514
    159 Coram CVS/Specialty Infusion Services - Oklahoma City Oklahoma City Oklahoma United States 73127
    160 Central States Research Tulsa Oklahoma United States 74136
    161 Optum Infusion - Bend Bend Oregon United States 97701
    162 Velocity Clinical Research - Medford Medford Oregon United States 97504
    163 Center for Cognitive Health Portland Oregon United States 97225
    164 The Clinical Trial Center, LLC Jenkintown Pennsylvania United States 19046
    165 Suburban Research Associates Media Pennsylvania United States 19063
    166 Care Access - Pottsville Pottsville Pennsylvania United States 17901
    167 Care Access - Warwick Warwick Rhode Island United States 02886
    168 Care Access - Anderson Anderson South Carolina United States 29621
    169 Velocity Clinical Research, Anderson Anderson South Carolina United States 29621
    170 Velocity Clinical Research, Columbia Columbia South Carolina United States 29204
    171 Velocity Clinical Research, Gaffney Gaffney South Carolina United States 29340
    172 VitaLink Research - Greenville Greenville South Carolina United States 29615
    173 Care Access - Mauldin Mauldin South Carolina United States 29662
    174 Velocity Clinical Research, Spartanburg Spartanburg South Carolina United States 29303
    175 VitaLink Research - Union Union South Carolina United States 29379
    176 Health Concepts Rapid City South Dakota United States 57702
    177 Neurology Clinic, P.C. Cordova Tennessee United States 38018
    178 Clinical Neuroscience Solutions Inc Memphis Tennessee United States 38119
    179 Care Access - Austin Austin Texas United States 78735
    180 Texas Diabetes & Endocrinology, P.A. Austin Texas United States 78749
    181 Senior Adults Specialty Research Austin Texas United States 78757
    182 Gadolin Research Beaumont Texas United States 77702
    183 Conroe Willis Medical Research Conroe Texas United States 77304
    184 Advanced Neuro Research Center - ANRC El Paso Texas United States 79912
    185 Optum Infusion - Houston Houston Texas United States 77054
    186 The University of Texas Health Science Center at Houston Houston Texas United States 77054
    187 Next Level Urgent Care Houston Texas United States 77057
    188 Family Practice Center McAllen Texas United States 78501
    189 Benchmark Research - Knickerbocker San Angelo Texas United States 76904
    190 Diagnostics Research Group San Antonio Texas United States 78229
    191 Consano Clinical Research, LLC Shavano Park Texas United States 78231
    192 Texas Valley Clinical Research Weslaco Texas United States 78596
    193 University of Utah Neurology Salt Lake City Utah United States 84108
    194 The Memory Clinic Bennington Vermont United States 05201-9810
    195 Care Access - Alexandria Alexandria Virginia United States 22311
    196 Option Care - Chantilly Chantilly Virginia United States 20151
    197 Dominion Medical Associates, Inc. Richmond Virginia United States 23219
    198 Northwest Clinical Research Center Bellevue Washington United States 98007
    199 Universal Research Group Tacoma Washington United States 98405
    200 Optum Infusion - Woodinville Woodinville Washington United States 98072
    201 IMA Clinical Research Morgantown West Virginia United States 26505
    202 National Center for Geriatrics and Gerontology Obu Aichi Japan 474-8511
    203 Oita University Hospital Yufu Oita Japan 879-5593
    204 Medical Corporation Heishinkai OCROM Clinic Suita-shi Osaka Japan 565-0853
    205 The University of Tokyo Hospital Bunkyo-ku Tokyo Japan 113-8655
    206 Tokyo-Eki Center-building Clinic Chuo-ku Tokyo Japan 103-0027
    207 Fukuwa Clinic Chuo-ku Tokyo Japan 104-0031
    208 P-One Clinic Hachioji Tokyo Japan 192-0071
    209 Tokyo Metropolitan Geriatric Hospital Itabashi Tokyo Japan 173-0015
    210 Heishinkai Medical Group ToCROM Clinic Shinjuku-ku Tokyo Japan 160-0008
    211 Samoncho Clinic Shinjuku Tokyo Japan 160-0017
    212 AMC Nishiumeda Clinic Osaka Japan 530-0001
    213 Tokyo Asbo Clinic Tokyo Japan 104-0031
    214 SCB Research Center Bayamon Puerto Rico 00961
    215 Dr. Samuel Sanchez PSC Caguas Puerto Rico 00727
    216 INSPIRA Clinical Research San Juan Puerto Rico 00918
    217 Instituto De Neurologia Dra. Ivonne Fraga San Juan Puerto Rico 00918
    218 Mindful Medical Research San Juan Puerto Rico 00918
    219 University of Puerto Rico - Medical Sciences Campus_Do not use - Duplicate facility San Juan Puerto Rico 00936

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT05026866
    Other Study ID Numbers:
    • 18284
    • I5T-MC-AACM
    First Posted:
    Aug 30, 2021
    Last Update Posted:
    Aug 19, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Alzheimer Disease

    Study Results

    No Results Posted as of Aug 19, 2022