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

Primary Purpose

Alzheimer's Disease, Dementia, Brain Diseases

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Donanemab
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

Eligibility Criteria

60 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. 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.

Sites / Locations

  • MD First Research - ChandlerRecruiting
  • Irvine Clinical ResearchRecruiting
  • Healthy Brain ClinicRecruiting
  • California Neuroscience Research Medical Group, Inc.Recruiting
  • JEM Research InstituteRecruiting
  • VIN-Julie SchwartzbardRecruiting
  • Excel Medical Clinical TrialsRecruiting
  • Brain Matters ResearchRecruiting
  • Neuropsychiatric Research Center of Southwest FloridaRecruiting
  • Finlay Medical ResearchRecruiting
  • Infinity Clinical Research, LLCRecruiting
  • Encore Research Group- Jacksonville Center for Clinical ResearchRecruiting
  • Charter Research - Lady LakeRecruiting
  • K2 Medical ResearchRecruiting
  • ClinCloud - VieraRecruiting
  • Suncoast Clinical Research, Inc.Recruiting
  • Renstar Medical ResearchRecruiting
  • Progressive Medical ResearchRecruiting
  • Alzheimer's Research and Treatment CenterRecruiting
  • K2 Medical Research - TampaRecruiting
  • K2 Summit ResearchRecruiting
  • ClinCloud - MaitlandRecruiting
  • Alzheimer's Research and Treatment CenterRecruiting
  • Palm Beach NeurologyRecruiting
  • Conquest ResearchRecruiting
  • Charter Research - Winter ParkRecruiting
  • Columbus Memory Center, PCRecruiting
  • CenExel iResearch, LLCRecruiting
  • Center for Advanced Research & EducationRecruiting
  • CenExel iResearch, LLCRecruiting
  • MedVadis Research CorporationRecruiting
  • Adams ClinicalRecruiting
  • QUEST Research InstituteRecruiting
  • The Cognitive and Research Center of New JerseyRecruiting
  • Butler HospitalRecruiting
  • Neurology Clinic, P.C.Recruiting
  • Gadolin ResearchRecruiting
  • Kerwin Medical CenterRecruiting
  • The University of Texas Health Science Center at HoustonRecruiting
  • Re:Cognition HealthRecruiting
  • Northwest Clinical Research CenterRecruiting
  • Universal Research GroupRecruiting
  • Re:Cognition Health - BristolRecruiting
  • Re:Cognition Health - WinchesterRecruiting
  • Re:Cognition Health - LondonRecruiting
  • Re:Cognition Health - BirminghamRecruiting
  • Re:Cognition Health - PlymouthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Donanemab Dose Level 1

Donanemab Dose Level 2

Donanemab Dose Level 3

Donanemab Dose Level 4

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Percentage of Participants with Any Occurence of Amyloid-Related Imaging Abnormality-Edema/Effusion (ARIA-E)

Secondary Outcome Measures

Percentage of Participants with Any Occurence of ARIA-E
Change from Baseline in Brain Amyloid Plaque Deposition As Measured By Amyloid Positron Emission Tomography (PET) Scan
Percentage of Participants with Any Occurrence of Amyloid-Related Imaging Abnormality-Hemorrhage/Hemosiderin Deposits (ARIA-H)
Percentage of Participants with ARIA-H
Percentage of Participants with Maximum Severity of ARIA-E or ARIA-H
Pharmacokinetics (PK): Average Serum Concentration of Donanemab
Number of Participants with Anti-Drug Antibodies (ADAs) Against Donanemab, including Treatment Emergent ADAs and Neutralizing Antibodies

Full Information

First Posted
February 13, 2023
Last Updated
October 10, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT05738486
Brief Title
A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)
Official Title
Investigating the Effect of Different Donanemab Dosing Regimens on ARIA-E and Amyloid Lowering in Adults With Early Symptomatic Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2023 (Actual)
Primary Completion Date
March 19, 2024 (Anticipated)
Study Completion Date
May 13, 2025 (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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Neurodegenerative Diseases, Neurocognitive Disorders, Mental Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Phase 3b
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Donanemab Dose Level 1
Arm Type
Experimental
Arm Description
Participants will receive donanemab by intravenously (IV) infusion. Participants will receive placebo at certain intervals to preserve the blind.
Arm Title
Donanemab Dose Level 2
Arm Type
Experimental
Arm Description
Participants will receive donanemab by IV infusion. Participants will receive placebo at certain intervals to preserve the blind.
Arm Title
Donanemab Dose Level 3
Arm Type
Experimental
Arm Description
Participants will receive donanemab by IV infusion. Participants will receive placebo at certain intervals to preserve the blind.
Arm Title
Donanemab Dose Level 4
Arm Type
Experimental
Arm Description
Participants will receive donanemab by IV infusion. Participants will receive placebo at certain intervals to preserve the blind.
Intervention Type
Drug
Intervention Name(s)
Donanemab
Other Intervention Name(s)
LY3002813
Intervention Description
Administered IV
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered IV
Primary Outcome Measure Information:
Title
Percentage of Participants with Any Occurence of Amyloid-Related Imaging Abnormality-Edema/Effusion (ARIA-E)
Time Frame
24 Weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants with Any Occurence of ARIA-E
Time Frame
52 Weeks
Title
Change from Baseline in Brain Amyloid Plaque Deposition As Measured By Amyloid Positron Emission Tomography (PET) Scan
Time Frame
Baseline, 76 Weeks
Title
Percentage of Participants with Any Occurrence of Amyloid-Related Imaging Abnormality-Hemorrhage/Hemosiderin Deposits (ARIA-H)
Time Frame
24 Weeks
Title
Percentage of Participants with ARIA-H
Time Frame
52 Weeks
Title
Percentage of Participants with Maximum Severity of ARIA-E or ARIA-H
Time Frame
52 Weeks
Title
Pharmacokinetics (PK): Average Serum Concentration of Donanemab
Time Frame
Baseline to 52 Weeks
Title
Number of Participants with Anti-Drug Antibodies (ADAs) Against Donanemab, including Treatment Emergent ADAs and Neutralizing Antibodies
Time Frame
Baseline to End of Follow-Up (91 Weeks)

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 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.
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
Irvine Clinical Research
City
Irvine
State/Province
California
ZIP/Postal Code
92614
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
949-753-1663
First Name & Middle Initial & Last Name & Degree
Elly R Lee
Facility Name
Healthy Brain Clinic
City
Long Beach
State/Province
California
ZIP/Postal Code
90804
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
562-606-5999
First Name & Middle Initial & Last Name & Degree
Dung Trinh
Facility Name
California Neuroscience Research Medical Group, Inc.
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
818-990-2671
First Name & Middle Initial & Last Name & Degree
Thomas M Shiovitz
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
Excel Medical Clinical Trials
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33434
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
561-756-8206
First Name & Middle Initial & Last Name & Degree
Rasha Youssef
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
Infinity Clinical Research, LLC
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
954-620-3340
First Name & Middle Initial & Last Name & Degree
Harvey Schwartz
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
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
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
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
K2 Medical Research - Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelley Wilson Yokum
Facility Name
K2 Summit Research
City
The Villages
State/Province
Florida
ZIP/Postal Code
32159
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
352-500-5252
First Name & Middle Initial & Last Name & Degree
Craig Curtis
Facility Name
ClinCloud - Maitland
City
Viera
State/Province
Florida
ZIP/Postal Code
32940
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
407-636-4031
First Name & Middle Initial & Last Name & Degree
Esteban Olivera
Facility Name
Alzheimer's Research and Treatment Center
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
561-209-2400
First Name & Middle Initial & Last Name & Degree
David Watson
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
Center for Advanced Research & Education
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
7705345154
First Name & Middle Initial & Last Name & Degree
Angela Dawn Ritter
Facility Name
CenExel iResearch, LLC
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yael R Elfassy
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
QUEST Research Institute
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aaron Ellenbogen
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
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
401-655-6403
First Name & Middle Initial & Last Name & Degree
Meghan Riddle
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
901-866-9252
First Name & Middle Initial & Last Name & Degree
Thomas W Arnold
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
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
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
Arun Arora
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
Re:Cognition Health - Bristol
City
Bristol
State/Province
Bristol, City Of
ZIP/Postal Code
BS32 4SY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Phone
44033553536
First Name & Middle Initial & Last Name & Degree
Daniel John Lashley
Facility Name
Re:Cognition Health - Winchester
City
Winchester
State/Province
Hampshire
ZIP/Postal Code
SO21 1HU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Phone
44019625884
First Name & Middle Initial & Last Name & Degree
Steven J Allder
Facility Name
Re:Cognition Health - London
City
London
State/Province
London, City Of
ZIP/Postal Code
W1G 9JF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Phone
02033553536
First Name & Middle Initial & Last Name & Degree
Josephine Emer MacSweeney
Facility Name
Re:Cognition Health - Birmingham
City
Birmingham
ZIP/Postal Code
B16 8LT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Phone
01216550174
First Name & Middle Initial & Last Name & Degree
Conor Clerkin-Oliver
Facility Name
Re:Cognition Health - Plymouth
City
Plymouth
ZIP/Postal Code
PL6 8BT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Phone
441752875604
First Name & Middle Initial & Last Name & Degree
STEPHEN William PEARSON

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.lilly.com/en-US/trial/389475
Description
A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)

Learn more about this trial

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

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