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A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05738486
Collaborator
(none)
800
Enrollment
52
Locations
4
Arms
26.4
Anticipated Duration (Months)
15.4
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will investigate different donanemab dosing regimens and their effect on the frequency and severity of ARIA-E in adults with early symptomatic Alzheimer's disease (AD) and explore participant characteristics that might predict risk of ARIA.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
800 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Phase 3bPhase 3b
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Investigating the Effect of Different Donanemab Dosing Regimens on ARIA-E and Amyloid Lowering in Adults With Early Symptomatic Alzheimer's Disease
Anticipated Study Start Date :
Feb 28, 2023
Anticipated Primary Completion Date :
Mar 19, 2024
Anticipated Study Completion Date :
May 13, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Donanemab Dose Level 1

Participants will receive donanemab by intravenously (IV) infusion. Participants will receive placebo at certain intervals to preserve the blind.

Drug: Donanemab
Administered IV
Other Names:
  • LY3002813

    • Drug: Placebo
    Administered IV
    Experimental: Donanemab Dose Level 2

    Participants will receive donanemab by IV infusion. Participants will receive placebo at certain intervals to preserve the blind.

    Drug: Donanemab
    Administered IV
    Other Names:
  • LY3002813

    • Drug: Placebo
    Administered IV
    Experimental: Donanemab Dose Level 3

    Participants will receive donanemab by IV infusion. Participants will receive placebo at certain intervals to preserve the blind.

    Drug: Donanemab
    Administered IV
    Other Names:
  • LY3002813

    • Drug: Placebo
    Administered IV
    Experimental: Donanemab Dose Level 4

    Participants will receive donanemab by IV infusion. Participants will receive placebo at certain intervals to preserve the blind.

    Drug: Donanemab
    Administered IV
    Other Names:
  • LY3002813

    • Drug: Placebo
    Administered IV

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants with Any Occurence of Amyloid-Related Imaging Abnormality-Edema/Effusion (ARIA-E) [24 Weeks]

    Secondary Outcome Measures

    1. Percentage of Participants with Any Occurence of ARIA-E [52 Weeks]

    2. Change from Baseline in Brain Amyloid Plaque Deposition As Measured By Amyloid Positron Emission Tomography (PET) Scan [Baseline, 76 Weeks]

    3. Percentage of Participants with Any Occurrence of Amyloid-Related Imaging Abnormality-Hemorrhage/Hemosiderin Deposits (ARIA-H) [24 Weeks]

    4. Percentage of Participants with ARIA-H [52 Weeks]

    5. Percentage of Participants with Maximum Severity of ARIA-E or ARIA-H [52 Weeks]

    6. Pharmacokinetics (PK): Average Serum Concentration of Donanemab [Baseline to 52 Weeks]

    7. Number of Participants with Anti-Drug Antibodies (ADAs) Against Donanemab, including Treatment Emergent ADAs and Neutralizing Antibodies [Baseline to End of Follow-Up (91 Weeks)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Gradual and progressive change in memory function reported by the participant or informant for ≥6 months.

    • A mini mental state examination (MMSE) score of 20 to 28 (inclusive) at screening.

    • Have an amyloid PET scan result from central read, consistent with the presence of amyloid pathology.

    Exclusion Criteria:

    • Have significant neurological disease affecting the central nervous system other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson's disease, multiple concussions, or epilepsy or recurrent seizures, except febrile childhood seizures.

    • Has current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses in this study.

    • A life expectancy of <24 months

    • Have a presence or history of malignant neoplasms within the past 5 years prior to Visit 1.

    Exceptions:

    • non-metastatic basal- or squamous-cell skin cancer

    • Stage 0 non-invasive carcinoma of the cervix

    • Stage 0 non-invasive prostate cancer, or

    • other cancers with low risk of recurrence or spread

    • Contraindication to MRI or PET scans

    • Have had prior treatment with a passive anti-amyloid immunotherapy.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MD First Research - Chandler Chandler Arizona United States 85286
    2 Irvine Clinical Research Irvine California United States 92614
    3 Healthy Brain Clinic Long Beach California United States 90804
    4 California Neuroscience Research, LLC Sherman Oaks California United States 91403
    5 JEM Research Institute Atlantis Florida United States 33462
    6 Excel Medical Clinical Trials Boca Raton Florida United States 33434
    7 Brain Matters Research Delray Beach Florida United States 33445
    8 Finlay Medical Research Greenacres City Florida United States 33467
    9 Infinity Clinical Research, LLC Hollywood Florida United States 33024
    10 Jacksonville Center for Clinical Research Jacksonville Florida United States 32216
    11 Charter Research - Lady Lake Lady Lake Florida United States 32159
    12 ClinCloud - Maitland Maitland Florida United States 32751
    13 K2 Medical Research Maitland Florida United States 32751
    14 ClinCloud - Viera Melbourne Florida United States 32940
    15 Suncoast Clinical Research, Inc. New Port Richey Florida United States 34652
    16 Renstar Medical Research Ocala Florida United States 34470
    17 K2 Medical Research Ocoee Florida United States 34761
    18 Progressive Medical Research Port Orange Florida United States 32127
    19 Alzheimer's Research and Treatment Center Stuart Florida United States 34997
    20 K2 Summit Research The Villages Florida United States 32159
    21 Alzheimer's Research and Treatment Center Wellington Florida United States 33414
    22 Palm Beach Neurology West Palm Beach Florida United States 33407
    23 Conquest Research Winter Park Florida United States 32789
    24 Charter Research - Winter Park Winter Park Florida United States 32792
    25 Columbus Memory Center, LLC Columbus Georgia United States 31909
    26 CenExel iResearch, LLC Decatur Georgia United States 30030
    27 Center for Advanced Research & Education Gainesville Georgia United States 30501
    28 MedVadis Research Corporation Waltham Massachusetts United States 02451
    29 Adams Clinical Watertown Massachusetts United States 02472
    30 QUEST Research Institute Farmington Hills Michigan United States 48334
    31 The Cognitive and Research Center of New Jersey Springfield New Jersey United States 07081
    32 Neurology Clinic, P.C. Cordova Tennessee United States 38018
    33 Gadolin Research Beaumont Texas United States 77702
    34 The University of Texas Health Science Center at Houston Sugar Land Texas United States 77478
    35 Re:Cognition Health Fairfax Virginia United States 22031
    36 Northwest Clinical Research Center Bellevue Washington United States 98007
    37 Universal Research Group Tacoma Washington United States 98405
    38 AOU Policlinico Umberto I Roma Lazio Italy 00185
    39 Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano Lombardia Italy 20122
    40 Ospedale San Raffaele Milano Lombardia Italy 20132
    41 IRCCS Istituto Neurologico Carlo Besta Milano Lombardia Italy 20133
    42 "Fatebenefratelli Isola Tiberina - Gemelli Isola" Rome Roma Italy 00186
    43 Azienda Ospedaliera Universitaria Pisana Pisa Toscana Italy 56126
    44 Azienda Ospedaliera Spedali Civili di Brescia Brescia Italy 25123
    45 Fondazione Istituto Neurologico C. Mondino Pavia Italy 27100
    46 Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore Roma Italy 00168
    47 Re:Cognition Health - Bristol Bristol Bristol, City Of United Kingdom BS32 4SY
    48 Re:Cognition Health - Winchester Winchester Hampshire United Kingdom SO21 1HU
    49 Re:Cognition Health - London London London, City Of United Kingdom W1G 9JF
    50 Re:Cognition Health Guildford Guildford Reading United Kingdom GU2 7YD
    51 Re:Cognition Health - Birmingham Birmingham United Kingdom B16 8LT
    52 Re:Cognition Health - Plymouth Plymouth United Kingdom PL6 8BT

    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

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT05738486
    Other Study ID Numbers:
    • 18648
    • I5T-MC-AACQ
    • 2022-502268-18-00
    • U1111-1285-9438
    First Posted:
    Feb 22, 2023
    Last Update Posted:
    Feb 22, 2023
    Last Verified:
    Feb 1, 2023
    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
    Nervous System Diseases
    Neurodegenerative Diseases
    Brain Diseases
    Central Nervous System Diseases
    Disease
    Mental Disorders
    Neurocognitive Disorders

    Study Results

    No Results Posted as of Feb 22, 2023