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A Study of Remternetug (LY3372993) in Participants With Alzheimer's Disease (TRAILRUNNER-ALZ 1)

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05463731
Collaborator
(none)
400
Enrollment
75
Locations
4
Arms
39.5
Anticipated Duration (Months)
5.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The reason for this study is to collect safety and efficacy information regarding the study drug remternetug in participants with early Alzheimer's disease (AD).

Condition or Disease Intervention/Treatment Phase
  • Drug: Remternetug (IV)
  • Drug: Remternetug (SC)
  • Drug: Placebo
 Phase 3

Detailed Description

TRAILRUNNER-ALZ 1 is a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of remternetug in participants with early symptomatic AD. Participants will receive remternetug or placebo administered via subcutaneous injection or intravenous infusion.

Following the 52-week main study period, participants will continue participation for up to an additional 52 weeks in an extension period. Participants who previously received remternetug will receive placebo and participants who previously received placebo will receive remternetug. Thus, all participants will receive remternetug if they complete the study.

An additional 400 participants with early Alzheimer's disease will be enrolled to an addendum safety cohort. The participants will be administered open label remternetug via intravenous infusion. Participants from the addendum safety cohort are not eligible for the extension period.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Assessment of Safety, Tolerability, and Efficacy Measured by Amyloid Reduction of LY3372993 in Early Symptomatic Alzheimer's Disease
Actual Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Aug 5, 2024
Anticipated Study Completion Date :
Nov 15, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Remternetug (IV)

Participants will receive remternetug intravenously (IV) Participants will receive remternetug IV during the treatment period, then switch to placebo IV in the extension period.

Drug: Remternetug (IV)
Administered IV
Other Names:
  • LY3372993

    		•
    Experimental: Remternetug (SC)

    Participants will receive remternetug subcutaneously (SC) Participants will receive remternetug SC during the treatment period, then switch to placebo SC in the extension period.

    Drug: Remternetug (SC)
    Administered SC
    Other Names:
  • LY3372993

    		•
    Placebo Comparator: Placebo

    Participants will receive placebo matching remternetug IV or SC Participants will receive placebo IV or SC during the treatment period, then switch to remternetug IV or SC in the extension period. Participants will receive placebo SC during the treatment period, then switch to LY3372993 SC in the extension period.

    Drug: Placebo
    Administered IV or SC
    Experimental: Open-Label Addenda Remternetug (IV)

    Participants will receive one of two dosing regimens of remternetug IV during the open-label addenda.

    Drug: Remternetug (IV)
    Administered IV
    Other Names:
  • LY3372993

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants Who Reach Amyloid Plaque Clearance on Amyloid PET Scan for Remternetug versus Placebo [Week 52]

    Secondary Outcome Measures

    1. Mean Absolute Change from Baseline in Brain Amyloid Plaque on Amyloid PET Scan for Remternetug versus Placebo [Baseline, Week 52]

    2. Percentage of Participants Who Reach Amyloid Plaque Clearance on Amyloid PET Scan for Remternetug versus Placebo [Week 24]

    3. Mean Absolute Change from Baseline in Brain Amyloid Plaque on Amyloid PET Scan for Remternetug versus Placebo [Baseline, Week 24]

    4. Time to Reach Complete Amyloid Plaque Clearance on Remternetug versus Placebo [Up to Week 52]

    5. Pharmacokinetics (PK) Observed Trough Serum Concentration (Cmin) of Remternetug [Baseline to Week 52]

    6. Number of Participants with Treatment Emergent Anti-Drug Antibodies (TE-ADAs) [Baseline to Week 52]

    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 cognitive function ≥6 months prior to screening.

    • A Mini-Mental (MMSE) score of 20 to 28 (inclusive) at screening.

    • Has a P-tau result consistent with the presence of amyloid pathology.

    • Has an amyloid PET scan result consistent with the presence of brain amyloid pathology.

    • Have a reliable study partner who will provide written informed consent to participate and is in frequent contact with the participant.

    • Have adequate literacy, vision, and hearing for the neuropsychological testing in the opinion of the investigator at the time of screening.

    • Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.

    • Males and females will be eligible for this study.

    • Women not of childbearing potential (WNOCBP) may participate in this trial.

    Exclusion Criteria:

    • Significant neurological disease affecting the central nervous system (CNS) other than AD, that may affect cognition or ability to complete the study.

    • Current serious or unstable illnesses that, in the investigator's opinion, could interfere with the analyses in this study; or has a life expectancy of <24 months.

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

    • Participants with any current primary psychiatric diagnosis other than AD that in the investigator's opinion, is likely to confound interpretation of the drug effect, affect cognitive assessment, or affect the participant's ability to complete the study.

    • History of of clinically significant multiple or severe drug allergies.

    • Have any clinically important abnormality at screening, as determined by investigator that could be detrimental to the participant, could compromise the study, or show evidence of other etiologies for dementia.

    • Screening magnetic resonance imaging (MRI) which shows evidence of significant abnormality that would suggest another potential etiology for progressive dementia or a clinically significant finding that may impact the participant's ability to safely participate in the study.

    • Have any contraindications for MRI or positron emission tomography (PET).

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

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

    • Have known allergies to remternetug related compounds, or any components of the formulation.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MD First Research - Chandler Chandler Arizona United States 85286
    2 Hope Clinical Research, Inc. Canoga Park California United States 91303
    3 North County Neurology Associates Carlsbad California United States 92011
    4 Wr- Pri, Llc Encino California United States 91316
    5 Neuro-Pain Medical Center Fresno California United States 93710
    6 Irvine Clinical Research Irvine California United States 92614
    7 Kaizen Brain Center La Jolla California United States 92037
    8 Anderson Clinical Research Redlands California United States 92374
    9 Mountain Neurological Research Center Basalt Colorado United States 81621
    10 Alpine Clinical Research Center Boulder Colorado United States 80301
    11 Colorado Springs Neurological Associates Colorado Springs Colorado United States 80907
    12 Institute for Neurodegenerative Disorders New Haven Connecticut United States 06510
    13 Ki Health Partners, LLc, dba New England Institute for Clinical Research Stamford Connecticut United States 06905
    14 JEM Research Institute Atlantis Florida United States 33462
    15 VIN-Julie Schwartzbard Aventura Florida United States 33180
    16 Brain Matters Research Delray Beach Florida United States 33445
    17 Neuropsychiatric Research Center of Southwest Florida Fort Myers Florida United States 33912
    18 Finlay Medical Research Greenacres City Florida United States 33467
    19 Jacksonville Center for Clinical Research Jacksonville Florida United States 32216
    20 Charter Research - Lady Lake Lady Lake Florida United States 32159
    21 ClinCloud - Maitland Maitland Florida United States 32751
    22 K2 Medical Research Maitland Florida United States 32751
    23 ClinCloud - Viera Melbourne Florida United States 32940
    24 Merritt Island Medical Research, LLC Merritt Island Florida United States 32952
    25 Optimus U Corporation Miami Florida United States 33125
    26 VIN-Andrew Lerman Miami Florida United States 33133
    27 Suncoast Clinical Research, Inc. New Port Richey Florida United States 34652
    28 Renstar Medical Research Ocala Florida United States 34470
    29 Emerald Coast Neurology - Airport Boulevard Pensacola Florida United States 32504
    30 Progressive Medical Research Port Orange Florida United States 32127
    31 Alzheimer's Research and Treatment Center Stuart Florida United States 34997
    32 Brain Matters Research Stuart Florida United States 34997
    33 Tallahassee Neurological Clinic Tallahassee Florida United States 32308
    34 Alzheimer's Research and Treatment Center Wellington Florida United States 33414
    35 Palm Beach Neurology West Palm Beach Florida United States 33407
    36 Conquest Research Winter Park Florida United States 32789
    37 Charter Research - Winter Park Winter Park Florida United States 32792
    38 Columbus Memory Center, PC Columbus Georgia United States 31909
    39 North Georgia Clinical Research Woodstock Georgia United States 30189
    40 Great Lakes Clinical Trials - Andersonville Chicago Illinois United States 60640
    41 Alexian Brothers Medical Center Elk Grove Village Illinois United States 60007
    42 Covenant Medical Center Waterloo Iowa United States 50702
    43 Cotton O'Neil Mulvane Topeka Kansas United States 66606
    44 Care Access - Lake Charles Lake Charles Louisiana United States 70601
    45 MedVadis Research Corporation Waltham Massachusetts United States 02451
    46 Adams Clinical Watertown Massachusetts United States 02472
    47 Citizens Memorial Hospital District Bolivar Missouri United States 65613
    48 Clinical Research Professionals Chesterfield Missouri United States 63005
    49 Las Vegas Medical Research Las Vegas Nevada United States 89113
    50 The Cognitive and Research Center of New Jersey Springfield New Jersey United States 07081
    51 Advanced Memory Research Institute of New Jersey Toms River New Jersey United States 08755
    52 Neurological Associates Albany Albany New York United States 12208
    53 AMC Research, LLC Matthews North Carolina United States 28105
    54 Carteret Medical Group Morehead City North Carolina United States 28557
    55 NeuroScience Research Center Canton Ohio United States 44718
    56 Valley Medical Research Centerville Ohio United States 45459
    57 Neurology Diagnostics, Inc. Dayton Ohio United States 45459
    58 Summit Headlands Portland Oregon United States 97210
    59 Center for Cognitive Health Portland Oregon United States 97225
    60 The Clinical Trial Center, LLC Jenkintown Pennsylvania United States 19046
    61 Keystone Clinical Studies Plymouth Meeting Pennsylvania United States 19462
    62 Rhode Island Mood & Memory Research Institute East Providence Rhode Island United States 02914
    63 Neurology Clinic, P.C. Cordova Tennessee United States 38018
    64 Texas Diabetes & Endocrinology, P.A. Austin Texas United States 78749
    65 Gadolin Research Beaumont Texas United States 77702
    66 Kerwin Medical Center Dallas Texas United States 75231
    67 Neurology Consultants of Dallas, PA Dallas Texas United States 75243
    68 Central Texas Neurology Consultants Round Rock Texas United States 78681
    69 Consano Clinical Research, LLC Shavano Park Texas United States 78231
    70 The University of Texas Health Science Center at Houston Sugar Land Texas United States 77478
    71 The Memory Clinic Bennington Vermont United States 05201-9810
    72 Re:Cognition Health Fairfax Virginia United States 22031
    73 National Clinical Research, Inc Richmond Virginia United States 23294
    74 Northwest Clinical Research Center Bellevue Washington United States 98007
    75 Universal Research Group Tacoma Washington United States 98405

    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:
    NCT05463731
    Other Study ID Numbers:
    • 18467
    • J1G-MC-LAKC
    First Posted:
    Jul 19, 2022
    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
    Keywords provided by Eli Lilly and Company
    Mild cognitive impairment
    Alzheimer's disease
    Dementia
    Amyloid-beta therapy
    Amyloid Plaque
    Disease modifying
    Additional relevant MeSH terms:
    Alzheimer Disease

    Study Results

    No Results Posted as of Aug 19, 2022