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

Primary Purpose

Alzheimer's Disease

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Remternetug (IV)
Remternetug (SC)
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Mild cognitive impairment, Alzheimer's disease, Dementia, Amyloid-beta therapy, Amyloid Plaque, Disease modifying

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • MD First Research - ChandlerRecruiting
  • Hope Clinical Research, Inc.Recruiting
  • North County Neurology AssociatesRecruiting
  • Wr- Pri, LlcRecruiting
  • Neuro-Pain Medical CenterRecruiting
  • Irvine Clinical ResearchRecruiting
  • Kaizen Brain CenterRecruiting
  • Anderson Clinical ResearchRecruiting
  • Mountain Neurological Research CenterRecruiting
  • Alpine Clinical Research CenterRecruiting
  • Colorado Springs Neurological AssociatesRecruiting
  • Ki Health Partners, LLc, dba New England Institute for Clinical ResearchRecruiting
  • JEM Research InstituteRecruiting
  • VIN-Julie SchwartzbardRecruiting
  • Brain Matters ResearchRecruiting
  • Neuropsychiatric Research Center of Southwest FloridaRecruiting
  • Finlay Medical ResearchRecruiting
  • Encore Research Group- Jacksonville Center for Clinical ResearchRecruiting
  • Charter Research - Lady LakeRecruiting
  • ClinCloud - MaitlandRecruiting
  • K2 Medical ResearchRecruiting
  • ClinCloud - VieraRecruiting
  • Merritt Island Medical Research, LLCRecruiting
  • VIN-Andrew LermanRecruiting
  • Optimus U CorporationRecruiting
  • Suncoast Clinical Research, Inc.Recruiting
  • Renstar Medical ResearchRecruiting
  • Emerald Coast Neurology - Airport BoulevardRecruiting
  • Progressive Medical ResearchRecruiting
  • Alzheimer's Research and Treatment CenterRecruiting
  • Brain Matters ResearchRecruiting
  • Tallahassee Neurological ClinicRecruiting
  • Palm Beach NeurologyRecruiting
  • Conquest ResearchRecruiting
  • Charter Research - Winter ParkRecruiting
  • Columbus Memory Center, PCRecruiting
  • CenExel iResearch, LLCRecruiting
  • Great Lakes Clinical Trials - AndersonvilleRecruiting
  • AMITA Health - Alexian Brothers Neurosciences Institute Clinical ResearchRecruiting
  • Cotton O'Neil Clinical Research Center - Central OfficeRecruiting
  • Care Access - Lake CharlesRecruiting
  • MedVadis Research CorporationRecruiting
  • Adams ClinicalRecruiting
  • Covenant Medical CenterRecruiting
  • Citizens Memorial Hospital DistrictRecruiting
  • Clinical Research ProfessionalsRecruiting
  • Las Vegas Medical ResearchRecruiting
  • The Cognitive and Research Center of New JerseyRecruiting
  • Advanced Memory Research Institute of New JerseyRecruiting
  • Neurological Associates AlbanyRecruiting
  • AMC ResearchRecruiting
  • Carteret Medical GroupRecruiting
  • NeuroScience Research CenterRecruiting
  • Valley Medical ResearchRecruiting
  • Neurology Diagnostics, Inc.Recruiting
  • Center for Cognitive HealthRecruiting
  • The Clinical Trial Center, LLCRecruiting
  • Keystone Clinical StudiesRecruiting
  • Rhode Island Mood & Memory Research InstituteRecruiting
  • Neurology Clinic, P.C.Recruiting
  • Texas Diabetes & Endocrinology, P.A.Recruiting
  • Gadolin ResearchRecruiting
  • Kerwin Medical CenterRecruiting
  • Neurology Consultants of Dallas, PARecruiting
  • Central Texas Neurology ConsultantsRecruiting
  • Consano Clinical Research, LLCRecruiting
  • The University of Texas Health Science Center at HoustonRecruiting
  • Re:Cognition HealthRecruiting
  • National Clinical Research, IncRecruiting
  • Northwest Clinical Research CenterRecruiting
  • Universal Research GroupRecruiting
  • Memory Clinic TorideRecruiting
  • Katayama Medical Clinic
  • Memory Clinic OchanomizuRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

Remternetug (IV)

Remternetug (SC)

Placebo

Open-Label Addenda Remternetug (IV)

Open-Label Addenda Remternetug (SC)

Arm Description

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

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

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

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

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

Outcomes

Primary Outcome Measures

Percentage of Participants Who Reach Amyloid Plaque Clearance on Amyloid PET Scan for Remternetug versus Placebo

Secondary Outcome Measures

Mean Absolute Change from Baseline in Brain Amyloid Plaque on Amyloid PET Scan for Remternetug versus Placebo
Percentage of Participants Who Reach Amyloid Plaque Clearance on Amyloid PET Scan for Remternetug versus Placebo
Mean Absolute Change from Baseline in Brain Amyloid Plaque on Amyloid PET Scan for Remternetug versus Placebo
Time to Reach Complete Amyloid Plaque Clearance on Remternetug versus Placebo
Pharmacokinetics (PK) Observed Trough Serum Concentration (Cmin) of Remternetug
Number of Participants with Treatment Emergent Anti-Drug Antibodies (TE-ADAs)

Full Information

First Posted
July 14, 2022
Last Updated
October 16, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT05463731
Brief Title
A Study of Remternetug (LY3372993) in Participants With Alzheimer's Disease (TRAILRUNNER-ALZ 1)
Official Title
Assessment of Safety, Tolerability, and Efficacy Measured by Amyloid Reduction of LY3372993 in Early Symptomatic Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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).
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. Initially, 600 participants will enrollin the double-blind treatment period. Participants in the double-blind treatment period 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 640 participants with early Alzheimer's disease will be enrolled to an addendum safety cohort. The participants will be administered open label remternetug via subcutaneous injection or intravenous infusion. Participants enrolled into the addendum safety cohort are not eligible for the extension period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Mild cognitive impairment, Alzheimer's disease, Dementia, Amyloid-beta therapy, Amyloid Plaque, Disease modifying

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
The main treatment period is double-blinded and the addendum is open-label.
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Remternetug (IV)
Arm Type
Experimental
Arm Description
Participants will receive remternetug intravenously (IV) Participants will receive remternetug IV during the treatment period, then switch to placebo IV in the extension period.
Arm Title
Remternetug (SC)
Arm Type
Experimental
Arm Description
Participants will receive one of two dosing regimens of remternetug subcutaneously (SC) Participants will receive remternetug SC during the treatment period, then switch to placebo SC in the extension period.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo matching remternetug IV or SC. Participants will receive placebo IV during the treatment period, then switch to remternetug IV in the extension period. Participants will receive placebo SC during the treatment period, then switch to LY3372993 SC in the extension period.
Arm Title
Open-Label Addenda Remternetug (IV)
Arm Type
Experimental
Arm Description
Participants will receive one of three dosing regimens of remternetug IV during the open-label addenda.
Arm Title
Open-Label Addenda Remternetug (SC)
Arm Type
Experimental
Arm Description
Participants will receive one of two dosing regimens of remternetug SC during the open-label addenda.
Intervention Type
Drug
Intervention Name(s)
Remternetug (IV)
Other Intervention Name(s)
LY3372993
Intervention Description
Administered IV
Intervention Type
Drug
Intervention Name(s)
Remternetug (SC)
Other Intervention Name(s)
LY3372993
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered IV or SC
Primary Outcome Measure Information:
Title
Percentage of Participants Who Reach Amyloid Plaque Clearance on Amyloid PET Scan for Remternetug versus Placebo
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Mean Absolute Change from Baseline in Brain Amyloid Plaque on Amyloid PET Scan for Remternetug versus Placebo
Time Frame
Baseline, Week 52
Title
Percentage of Participants Who Reach Amyloid Plaque Clearance on Amyloid PET Scan for Remternetug versus Placebo
Time Frame
Week 24
Title
Mean Absolute Change from Baseline in Brain Amyloid Plaque on Amyloid PET Scan for Remternetug versus Placebo
Time Frame
Baseline, Week 24
Title
Time to Reach Complete Amyloid Plaque Clearance on Remternetug versus Placebo
Time Frame
Up to Week 52
Title
Pharmacokinetics (PK) Observed Trough Serum Concentration (Cmin) of Remternetug
Time Frame
Baseline to Week 52
Title
Number of Participants with Treatment Emergent Anti-Drug Antibodies (TE-ADAs)
Time Frame
Baseline to Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone
1-317-615-4559
Email
ClinicalTrials.gov@lilly.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
MD First Research - Chandler
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85286
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
480-508-1038
First Name & Middle Initial & Last Name & Degree
Hemant K Pandey
Facility Name
Hope Clinical Research, Inc.
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
818-999-4673
First Name & Middle Initial & Last Name & Degree
Leon Barkodar
Facility Name
North County Neurology Associates
City
Carlsbad
State/Province
California
ZIP/Postal Code
92011
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
760-631-3000
First Name & Middle Initial & Last Name & Degree
Benjamin Frishberg
Facility Name
Wr- Pri, Llc
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
818-705-7450
First Name & Middle Initial & Last Name & Degree
Clifford R. Feldman
Facility Name
Neuro-Pain Medical Center
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
559-437-9700
First Name & Middle Initial & Last Name & Degree
PERMINDER BHATIA
Facility Name
Irvine Clinical Research
City
Irvine
State/Province
California
ZIP/Postal Code
92614
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elly R Lee
Facility Name
Kaizen Brain Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
866-277-2659
First Name & Middle Initial & Last Name & Degree
Collins Liu
Facility Name
Anderson Clinical Research
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
9097929007
First Name & Middle Initial & Last Name & Degree
Donald Lee Anderson
Facility Name
Mountain Neurological Research Center
City
Basalt
State/Province
Colorado
ZIP/Postal Code
81621
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
970-927-1141
First Name & Middle Initial & Last Name & Degree
Alison B Allen
Facility Name
Alpine Clinical Research Center
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
3034437229
First Name & Middle Initial & Last Name & Degree
Paul Kenneth Brownstone, MD
Facility Name
Colorado Springs Neurological Associates
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christen Kutz
Facility Name
Ki Health Partners, LLc, dba New England Institute for Clinical Research
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
203-914-1903
First Name & Middle Initial & Last Name & Degree
Peter McAllister
Facility Name
JEM Research Institute
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
561-968-2933
First Name & Middle Initial & Last Name & Degree
Mark A Goldstein
Facility Name
VIN-Julie Schwartzbard
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
305-933-5993
First Name & Middle Initial & Last Name & Degree
Julie Schwartzbard
Facility Name
Brain Matters Research
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paayal Patel
Facility Name
Neuropsychiatric Research Center of Southwest Florida
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
239-939-7777
First Name & Middle Initial & Last Name & Degree
John Huffaker
Facility Name
Finlay Medical Research
City
Greenacres City
State/Province
Florida
ZIP/Postal Code
33467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
561-766-2181
First Name & Middle Initial & Last Name & Degree
Jorge J Calle Medina
Facility Name
Encore Research Group- Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
904-730-0101
First Name & Middle Initial & Last Name & Degree
Steven A Toenjes
Facility Name
Charter Research - Lady Lake
City
Lady Lake
State/Province
Florida
ZIP/Postal Code
32159
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
352-441-2000
First Name & Middle Initial & Last Name & Degree
Jeffrey A Norton
Facility Name
ClinCloud - Maitland
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
407-636-4031
First Name & Middle Initial & Last Name & Degree
Esteban Olivera
Facility Name
K2 Medical Research
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
407-670-5833
First Name & Middle Initial & Last Name & Degree
Brandon Lenox
Facility Name
ClinCloud - Viera
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32940
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
407-680-0534
First Name & Middle Initial & Last Name & Degree
Rosemary Laird
Facility Name
Merritt Island Medical Research, LLC
City
Merritt Island
State/Province
Florida
ZIP/Postal Code
32952
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
321-305-5015
First Name & Middle Initial & Last Name & Degree
Gregory Kirk
Facility Name
VIN-Andrew Lerman
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
786-655-8010
First Name & Middle Initial & Last Name & Degree
Andrew Lerman
Facility Name
Optimus U Corporation
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
305-240-5206
First Name & Middle Initial & Last Name & Degree
Yaneicy Gonzalez Rojas
Facility Name
Suncoast Clinical Research, Inc.
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
727-849-4131
First Name & Middle Initial & Last Name & Degree
Cathy Barnes
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
3526295800
First Name & Middle Initial & Last Name & Degree
John Paul Nardandrea
Facility Name
Emerald Coast Neurology - Airport Boulevard
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
850-438-1136
First Name & Middle Initial & Last Name & Degree
David M Bear
Facility Name
Progressive Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
386-304-7070
First Name & Middle Initial & Last Name & Degree
Alexander J. White
Facility Name
Alzheimer's Research and Treatment Center
City
Stuart
State/Province
Florida
ZIP/Postal Code
34997
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
561-209-2400
First Name & Middle Initial & Last Name & Degree
David Watson
Facility Name
Brain Matters Research
City
Stuart
State/Province
Florida
ZIP/Postal Code
34997
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
561-374-8461
First Name & Middle Initial & Last Name & Degree
Paayal Patel
Facility Name
Tallahassee Neurological Clinic
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
850-558-1238
First Name & Middle Initial & Last Name & Degree
Ricardo Ayala
Facility Name
Palm Beach Neurology
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
561-845-0500
First Name & Middle Initial & Last Name & Degree
Paul Winner
Facility Name
Conquest Research
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
407-916-0060
First Name & Middle Initial & Last Name & Degree
Malisa Agard
Facility Name
Charter Research - Winter Park
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32792
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
407-337-1000
First Name & Middle Initial & Last Name & Degree
Edgardo J Rivera-Rivera
Facility Name
Columbus Memory Center, PC
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31909
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
706-653-8455
First Name & Middle Initial & Last Name & Degree
Jonathan L. Liss
Facility Name
CenExel iResearch, LLC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
404-537-1281
First Name & Middle Initial & Last Name & Degree
Kimball A. Johnson
Facility Name
Great Lakes Clinical Trials - Andersonville
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
773-275-3500
First Name & Middle Initial & Last Name & Degree
Jeffrey S. Ross
Facility Name
AMITA Health - Alexian Brothers Neurosciences Institute Clinical Research
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Concetta M. Forchetti
Facility Name
Cotton O'Neil Clinical Research Center - Central Office
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
785-354-9591
First Name & Middle Initial & Last Name & Degree
Katherine Willingham
Facility Name
Care Access - Lake Charles
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
337-602-6642
First Name & Middle Initial & Last Name & Degree
Jason Morris
Facility Name
MedVadis Research Corporation
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
617-744-1310
First Name & Middle Initial & Last Name & Degree
David DiBenedetto
Facility Name
Adams Clinical
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
6177448542
First Name & Middle Initial & Last Name & Degree
Stephanie Buchman Rutrick
Facility Name
Covenant Medical Center
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48602
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
NICHOLAS JAMES GOETSCH
Facility Name
Citizens Memorial Hospital District
City
Bolivar
State/Province
Missouri
ZIP/Postal Code
65613
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
417-328-7781
First Name & Middle Initial & Last Name & Degree
Curtis P. Schreiber
Facility Name
Clinical Research Professionals
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63005
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
636-220-1200
First Name & Middle Initial & Last Name & Degree
Siddharth Kaul
Facility Name
Las Vegas Medical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89113
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
702-750-0222
First Name & Middle Initial & Last Name & Degree
Bharat R Mocherla
Facility Name
The Cognitive and Research Center of New Jersey
City
Springfield
State/Province
New Jersey
ZIP/Postal Code
07081
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
973-850-4622
First Name & Middle Initial & Last Name & Degree
Michelle Papka
Facility Name
Advanced Memory Research Institute of New Jersey
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
732-341-9500
First Name & Middle Initial & Last Name & Degree
Sanjiv Sharma
Facility Name
Neurological Associates Albany
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
518-426-0575
First Name & Middle Initial & Last Name & Degree
Richard Holub
Facility Name
AMC Research
City
Matthews
State/Province
North Carolina
ZIP/Postal Code
28105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammad Reza Bolouri
Facility Name
Carteret Medical Group
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
2524998623
First Name & Middle Initial & Last Name & Degree
Mary Katherine Lawrence
Facility Name
NeuroScience Research Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
330-244-2542
First Name & Middle Initial & Last Name & Degree
Ryan S Drake
Facility Name
Valley Medical Research
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meenakshi C. Patel
Facility Name
Neurology Diagnostics, Inc.
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
937-224-8200
First Name & Middle Initial & Last Name & Degree
Joel Vandersluis
Facility Name
Center for Cognitive Health
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
5032072066
First Name & Middle Initial & Last Name & Degree
Michael Steven Mega
Facility Name
The Clinical Trial Center, LLC
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
215-884-1700
First Name & Middle Initial & Last Name & Degree
Marvin Kalafer
Facility Name
Keystone Clinical Studies
City
Plymouth Meeting
State/Province
Pennsylvania
ZIP/Postal Code
19462
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
610-277-8073
First Name & Middle Initial & Last Name & Degree
Cherian Verghese
Facility Name
Rhode Island Mood & Memory Research Institute
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
401-435-8950
First Name & Middle Initial & Last Name & Degree
john stoukides
Facility Name
Neurology Clinic, P.C.
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
9018669252
First Name & Middle Initial & Last Name & Degree
Oleksandra Oleksandra Dryn
Facility Name
Texas Diabetes & Endocrinology, P.A.
City
Austin
State/Province
Texas
ZIP/Postal Code
78749
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Raymond
Facility Name
Gadolin Research
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77702
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
409-331-6040
First Name & Middle Initial & Last Name & Degree
Kandasami Senthilkumar
Facility Name
Kerwin Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
972-433-9100
First Name & Middle Initial & Last Name & Degree
Diana R Kerwin
Facility Name
Neurology Consultants of Dallas, PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
214-750-9977
First Name & Middle Initial & Last Name & Degree
Duc Tran
Facility Name
Central Texas Neurology Consultants
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
512-218-1222
First Name & Middle Initial & Last Name & Degree
Elizabeth Peckham
Facility Name
Consano Clinical Research, LLC
City
Shavano Park
State/Province
Texas
ZIP/Postal Code
78231
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
210-545-4900
First Name & Middle Initial & Last Name & Degree
Michelle Welch
Facility Name
The University of Texas Health Science Center at Houston
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
7134860536
First Name & Middle Initial & Last Name & Degree
Paul Ernest Schulz
Facility Name
Re:Cognition Health
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
2026877337
First Name & Middle Initial & Last Name & Degree
Raymond Scott Turner
Facility Name
National Clinical Research, Inc
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
8046722995
First Name & Middle Initial & Last Name & Degree
John Keith Scott
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
425-453-0404
First Name & Middle Initial & Last Name & Degree
Arifulla Khan, MD
Facility Name
Universal Research Group
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
2538821070
First Name & Middle Initial & Last Name & Degree
Sabrina Ann Benjamin
Facility Name
Memory Clinic Toride
City
Toride
State/Province
Ibaraki
ZIP/Postal Code
302-0004
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mitsuhiro Isozaki
Facility Name
Katayama Medical Clinic
City
Kurashiki
State/Province
Okayama
ZIP/Postal Code
710-0813
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sadao Katayama
Facility Name
Memory Clinic Ochanomizu
City
Tokyo
ZIP/Postal Code
113-0034
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
81368018718
First Name & Middle Initial & Last Name & Degree
Takashi Asada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
http://vivli.org/
Links:
URL
https://trials.lilly.com/en-US/trial/351135
Description
A Study of Remternetug (LY3372993) in Participants With Alzheimer's Disease (TRAILRUNNER-ALZ 1)

Learn more about this trial

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

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