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A Study of Donanemab (LY3002813) Compared With Aducanumab in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 4)

Primary Purpose

Mild Cognitive Impairment, Alzheimer Disease

Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Donanemab
Aducanumab
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Mild Cognitive Impairment due to Alzheimer's Disease

Eligibility Criteria

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

Inclusion Criteria:

  • Gradual and progressive change in memory function reported by the participant or informant for ≥6 months.
  • Meet florbetapir F18 PET scan criteria.
  • A Clinical Dementia Rating (CDR)-Global Score of 0.5 or 1.
  • Must consent to apolipoprotein E (ApoE) genotyping
  • Must have a mini mental state examination (MMSE) score between 20 and 30
  • Have a study partner who will provide written informed consent to participate, is in frequent contact with the participant (defined as at least 10 hours per week), and will accompany the participant to study visits or be available by telephone at designated times.
  • Have adequate literacy, vision, and hearing for neuropsychological testing in the opinion of the investigator at the time of screening.
  • Women not of childbearing potential may participate

Exclusion Criteria:

  • 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, history of transient ischemic attack or stroke, or epilepsy or recurrent seizures (except febrile childhood seizures).

  • Current serious or unstable medical illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, psychiatric (including actively suicidal or deemed at risk of suicide, or current alcohol or substance abuse), immunologic, infectious, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses in this study; or has a life expectancy of approximately

    ≤24 months.

  • 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).
  • History of bleeding disorder or use of medications with platelet anti-aggregant or anti-coagulant properties (unless aspirin at ≤325 milligram (mg).
  • Have had prior or current treatment with donanemab or aducanumab
  • Have known allergies to donanemab or aducanumab, related compounds, or any components of the formulation
  • Prior or current participation in any immunotherapy study targeting Amyloid beta

Sites / Locations

  • Neurology Center of North Orange County
  • Irvine Clinical Research
  • California Neuroscience Research Medical Group, Inc.
  • Institute for Neurodegenerative Disorders
  • JEM Research Institute
  • Brain Matters Research
  • Neuropsychiatric Research Center of Southwest Florida
  • Infinity Clinical Research, LLC
  • Jacksonville Center for Clinical Research
  • Charter Research - Lady Lake
  • ClinCloud - Maitland
  • ClinCloud - Viera
  • Merritt Island Medical Research, LLC
  • Optimus U Corporation
  • Brainstorm Research
  • Brain Matters Research
  • Axiom Clinical Research of Florida
  • Conquest Research
  • Columbus Memory Center, PC
  • Josephson Wallack Munshower Neurology, PC
  • Donald S. Marks M.D., P.C.
  • Adams Clinical
  • Clinical Research Professionals
  • Las Vegas Medical Research
  • The Cognitive and Research Center of New Jersey
  • Advanced Memory Research Institute of New Jersey
  • Neurology Diagnostics, Inc.
  • Abington Neurological Associates, Ltd.
  • The Clinical Trial Center, LLC
  • Kerwin Medical Center
  • National Clinical Research, Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Donanemab

Aducanumab

Arm Description

Donanemab is administered intravenously (IV) every 4 weeks (Q4W)

Aducanumab administered IV per label

Outcomes

Primary Outcome Measures

Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 Positron Emission Tomography (PET) Scan (Superiority) on donanemab versus aducanumab
Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab
Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan in the Intermediate Subpopulation (Superiority) on donanemab versus aducanumab
Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan in the intermediate subpopulation (Superiority) on donanemab versus aducanumab

Secondary Outcome Measures

Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab
Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab
Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab
Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab
Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab
Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab
Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Noninferiority) on donanemab 6 months versus aducanumab 12 months
Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Noninferiority) on donanemab 6 months versus aducanumab 12 months
Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Noninferiority) donanemab 6 months versus aducanumab 18 months
Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Noninferiority) donanemab 6 months versus aducanumab 18 months
Time to Reach Complete Amyloid Plaque Clearance on donanemab versus aducanumab
Time to reach complete amyloid plaque clearance on donanemab versus aducanumab
Mean Percent Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) donanemab versus aducanumab
Mean Percent Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) donanemab versus aducanumab
Mean Percent Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab
Mean Percent Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab
Mean Percent Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab
Mean Percent Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab
Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab
Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab
Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab
Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab
Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan in the Intermediate Tau Subpopulation (Superiority) on donanemab versus aducanumab
Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan in the Intermediate Tau Subpopulation (Superiority) on donanemab versus aducanumab
Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan in the Intermediate Tau Subpopulation (Superiority) on donanemab versus aducanumab
Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan in the Intermediate Tau Subpopulation (Superiority) on donanemab versus aducanumab
Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan in the Intermediate Tau Subpopulation (Superiority) on donanemab versus aducanumab
Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan in the Intermediate Tau Subpopulation (Superiority) on donanemab versus aducanumab
Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan in the Intermediate Tau Subpopulation (Superiority) on donanemab versus aducanumab
Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan in the Intermediate Tau Subpopulation (Superiority) on donanemab versus aducanumab
Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan in the Intermediate Tau Subpopulation (Superiority) on donanemab versus aducanumab
Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan in the Intermediate Tau Subpopulation (Superiority) on donanemab versus aducanumab
Change from Baseline in Brain Amyloid Plaque Reduction on Florbetapir F18 PET Scan (Superiority) donanemab 6 months versus aducanumab 12 months
Change from Baseline in Brain Amyloid Plaque Reduction on Florbetapir F18 PET Scan (Superiority) donanemab 6 months versus aducanumab 12 months

Full Information

First Posted
October 26, 2021
Last Updated
July 19, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT05108922
Brief Title
A Study of Donanemab (LY3002813) Compared With Aducanumab in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 4)
Official Title
A Phase 3, Open-Label, Parallel-Group, 2-Arm Study to Investigate Amyloid Plaque Clearance With Donanemab Compared With Aducanumab-avwa in Participants With Early Symptomatic Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 16, 2021 (Actual)
Primary Completion Date
September 9, 2022 (Actual)
Study Completion Date
September 5, 2023 (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 main purpose of this study is to compare donanemab to aducanumab on amyloid plaque clearance in participants with early symptomatic Alzheimer's Disease (AD).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Alzheimer Disease
Keywords
Mild Cognitive Impairment due to Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Donanemab
Arm Type
Experimental
Arm Description
Donanemab is administered intravenously (IV) every 4 weeks (Q4W)
Arm Title
Aducanumab
Arm Type
Active Comparator
Arm Description
Aducanumab administered IV per label
Intervention Type
Drug
Intervention Name(s)
Donanemab
Other Intervention Name(s)
LY3002813
Intervention Description
Administered IV
Intervention Type
Drug
Intervention Name(s)
Aducanumab
Intervention Description
Administered IV
Primary Outcome Measure Information:
Title
Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 Positron Emission Tomography (PET) Scan (Superiority) on donanemab versus aducanumab
Description
Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab
Time Frame
6 Months
Title
Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan in the Intermediate Subpopulation (Superiority) on donanemab versus aducanumab
Description
Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan in the intermediate subpopulation (Superiority) on donanemab versus aducanumab
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab
Description
Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab
Time Frame
Baseline, 6 Months
Title
Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab
Description
Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab
Time Frame
Baseline, 12 Months
Title
Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab
Description
Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab
Time Frame
Baseline, 18 Months
Title
Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Noninferiority) on donanemab 6 months versus aducanumab 12 months
Description
Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Noninferiority) on donanemab 6 months versus aducanumab 12 months
Time Frame
Baseline, 6 Months, 12 Months
Title
Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Noninferiority) donanemab 6 months versus aducanumab 18 months
Description
Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Noninferiority) donanemab 6 months versus aducanumab 18 months
Time Frame
Baseline, 6 Months, 18 Months
Title
Time to Reach Complete Amyloid Plaque Clearance on donanemab versus aducanumab
Description
Time to reach complete amyloid plaque clearance on donanemab versus aducanumab
Time Frame
Baseline to 18 Months
Title
Mean Percent Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) donanemab versus aducanumab
Description
Mean Percent Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) donanemab versus aducanumab
Time Frame
Baseline, 6 Months
Title
Mean Percent Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab
Description
Mean Percent Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab
Time Frame
Baseline, 12 Months
Title
Mean Percent Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab
Description
Mean Percent Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab
Time Frame
Baseline, 18 Months
Title
Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab
Description
Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab
Time Frame
12 Months
Title
Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab
Description
Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab
Time Frame
18 Months
Title
Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan in the Intermediate Tau Subpopulation (Superiority) on donanemab versus aducanumab
Description
Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan in the Intermediate Tau Subpopulation (Superiority) on donanemab versus aducanumab
Time Frame
12 Months
Title
Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan in the Intermediate Tau Subpopulation (Superiority) on donanemab versus aducanumab
Description
Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan in the Intermediate Tau Subpopulation (Superiority) on donanemab versus aducanumab
Time Frame
18 Months
Title
Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan in the Intermediate Tau Subpopulation (Superiority) on donanemab versus aducanumab
Description
Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan in the Intermediate Tau Subpopulation (Superiority) on donanemab versus aducanumab
Time Frame
Baseline, 6 Months
Title
Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan in the Intermediate Tau Subpopulation (Superiority) on donanemab versus aducanumab
Description
Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan in the Intermediate Tau Subpopulation (Superiority) on donanemab versus aducanumab
Time Frame
Baseline, 12 Months
Title
Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan in the Intermediate Tau Subpopulation (Superiority) on donanemab versus aducanumab
Description
Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan in the Intermediate Tau Subpopulation (Superiority) on donanemab versus aducanumab
Time Frame
Baseline, 18 Months
Title
Change from Baseline in Brain Amyloid Plaque Reduction on Florbetapir F18 PET Scan (Superiority) donanemab 6 months versus aducanumab 12 months
Description
Change from Baseline in Brain Amyloid Plaque Reduction on Florbetapir F18 PET Scan (Superiority) donanemab 6 months versus aducanumab 12 months
Time Frame
Baseline, 6 Months, 12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Gradual and progressive change in memory function reported by the participant or informant for ≥6 months. Meet florbetapir F18 PET scan criteria. A Clinical Dementia Rating (CDR)-Global Score of 0.5 or 1. Must consent to apolipoprotein E (ApoE) genotyping Must have a mini mental state examination (MMSE) score between 20 and 30 Have a study partner who will provide written informed consent to participate, is in frequent contact with the participant (defined as at least 10 hours per week), and will accompany the participant to study visits or be available by telephone at designated times. Have adequate literacy, vision, and hearing for neuropsychological testing in the opinion of the investigator at the time of screening. Women not of childbearing potential may participate Exclusion Criteria: 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, history of transient ischemic attack or stroke, or epilepsy or recurrent seizures (except febrile childhood seizures). Current serious or unstable medical illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, psychiatric (including actively suicidal or deemed at risk of suicide, or current alcohol or substance abuse), immunologic, infectious, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses in this study; or has a life expectancy of approximately ≤24 months. 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). History of bleeding disorder or use of medications with platelet anti-aggregant or anti-coagulant properties (unless aspirin at ≤325 milligram (mg). Have had prior or current treatment with donanemab or aducanumab Have known allergies to donanemab or aducanumab, related compounds, or any components of the formulation Prior or current participation in any immunotherapy study targeting Amyloid beta
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-2559) 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
Neurology Center of North Orange County
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Irvine Clinical Research
City
Irvine
State/Province
California
ZIP/Postal Code
92614
Country
United States
Facility Name
California Neuroscience Research Medical Group, Inc.
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Institute for Neurodegenerative Disorders
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
JEM Research Institute
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Brain Matters Research
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Facility Name
Neuropsychiatric Research Center of Southwest Florida
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Infinity Clinical Research, LLC
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Charter Research - Lady Lake
City
Lady Lake
State/Province
Florida
ZIP/Postal Code
32159
Country
United States
Facility Name
ClinCloud - Maitland
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
ClinCloud - Viera
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32940
Country
United States
Facility Name
Merritt Island Medical Research, LLC
City
Merritt Island
State/Province
Florida
ZIP/Postal Code
32952
Country
United States
Facility Name
Optimus U Corporation
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Brainstorm Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Brain Matters Research
City
Stuart
State/Province
Florida
ZIP/Postal Code
34997
Country
United States
Facility Name
Axiom Clinical Research of Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Conquest Research
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Columbus Memory Center, PC
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31909
Country
United States
Facility Name
Josephson Wallack Munshower Neurology, PC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Donald S. Marks M.D., P.C.
City
Plymouth
State/Province
Massachusetts
ZIP/Postal Code
02360
Country
United States
Facility Name
Adams Clinical
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Clinical Research Professionals
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63005
Country
United States
Facility Name
Las Vegas Medical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89113
Country
United States
Facility Name
The Cognitive and Research Center of New Jersey
City
Springfield
State/Province
New Jersey
ZIP/Postal Code
07081
Country
United States
Facility Name
Advanced Memory Research Institute of New Jersey
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Neurology Diagnostics, Inc.
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
Abington Neurological Associates, Ltd.
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
The Clinical Trial Center, LLC
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Kerwin Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
National Clinical Research, Inc
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States

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 European Union (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.lillytrialguide.com/en-US/trial/7lW96VnHH5irho2IpKQCFM
Description
A Study of Donanemab (LY3002813) Compared With Aducanumab in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 4)

Learn more about this trial

A Study of Donanemab (LY3002813) Compared With Aducanumab in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 4)

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