Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04437511
Registration number
NCT04437511
Ethics application status
Date submitted
17/06/2020
Date registered
18/06/2020
Titles & IDs
Public title
A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)
Query!
Scientific title
Assessment of Safety, Tolerability, and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease
Query!
Secondary ID [1]
0
0
I5T-MC-AACI
Query!
Secondary ID [2]
0
0
17737
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Alzheimer Disease
0
0
Query!
Condition category
Condition code
Neurological
0
0
0
0
Query!
Alzheimer's disease
Query!
Neurological
0
0
0
0
Query!
Dementias
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Donanemab
Treatment: Drugs - Placebo
Experimental: Donanemab - Participants received 700 milligram (mg) Donanemab every 4 weeks (Q4W) x 3 doses, then 1400 mg Q4W given intravenously (IV) for up to 72 weeks
Placebo comparator: Placebo - Participants received placebo given IV.
Treatment: Drugs: Donanemab
Given IV
Treatment: Drugs: Placebo
Given IV
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Overall Population)
Query!
Assessment method [1]
0
0
Integrated Alzheimer's Disease Rating Scale is used to assess whether donanemab slows down the clinical decline associated with AD compared with placebo. iADRS is an integrated assessment of cognition and daily function comprised of items from the ADAS-Cog13 and the Alzheimer's disease cooperative study-instrumental activities of daily living scale (ADCS-iADL). The scale ranges from 0 to 144, where lower scores indicate worse performance and higher score indicates better performance. Least Squares (LS) Mean value was adjusted for basis expansion terms (two terms), basis expansion term-by-treatment interaction, and covariates for age at baseline, pooled investigator, baseline tau level, and baseline acetylcholinesterase inhibitor (AchI)/Memantine use.
Query!
Timepoint [1]
0
0
Baseline, Week 76
Query!
Primary outcome [2]
0
0
Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Intermediate (Low-medium) Tau Population)
Query!
Assessment method [2]
0
0
Integrated Alzheimer's Disease Rating Scale is used to assess whether donanemab slows down the clinical decline associated with AD compared with placebo. iADRS is an integrated assessment of cognition and daily function comprised of items from the Alzheimer's disease assessment scale-cognitive subscale (ADAS-Cog13) and the Alzheimer's disease cooperative study-instrumental activities of daily living scale (ADCS-iADL). The scale ranges from 0 to 144, where lower scores indicate worse performance and higher score indicates better performance. LS Mean value was adjusted for basis expansion terms (two terms), basis expansion term-by-treatment interaction, and covariates for age at baseline, pooled investigator, and baseline AchI/Memantine use.
Query!
Timepoint [2]
0
0
Baseline, Week 76
Query!
Secondary outcome [1]
0
0
Change From Baseline on the Mini Mental State Examination (MMSE) Score (Overall Population)
Query!
Assessment method [1]
0
0
MMSE is an instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures). Total score ranges from 0 to 30; lower score indicates greater disease severity. LS Mean value was adjusted for basis expansion terms (two terms), basis expansion term-by-treatment interaction, and covariates for age at baseline, pooled investigator, baseline tau level, and baseline AchI/Memantine use.
Query!
Timepoint [1]
0
0
Baseline, Week 76
Query!
Secondary outcome [2]
0
0
Change From Baseline on the Mini Mental State Examination (MMSE) Score (Intermediate (Low-medium) Tau Population)
Query!
Assessment method [2]
0
0
MMSE is an instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures). Total score ranges from 0 to 30; lower score indicates greater disease severity. LS Mean value was adjusted for basis expansion terms (two terms), basis expansion term-by-treatment interaction, and covariates for age at baseline, pooled investigator, and baseline AchI/Memantine use.
Query!
Timepoint [2]
0
0
Baseline, Week 76
Query!
Secondary outcome [3]
0
0
Change From Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) (Overall Population)
Query!
Assessment method [3]
0
0
The ADAS-Cog13 is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with AD. The cognitive subscale of the ADAS-Cog13 consists of 13 items assessing areas of cognitive function most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, digit cancellation. The ADAS-Cog13 scale ranges from 0 to 85. Higher scores indicate greater disease severity. LS Mean value was adjusted for basis expansion terms (two terms), basis expansion term-by-treatment interaction, and covariates for age at baseline, pooled investigator, baseline tau level, and baseline AchI/Memantine use.
Query!
Timepoint [3]
0
0
Baseline, Week 76
Query!
Secondary outcome [4]
0
0
Change From Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) (Intermediate (Low-medium) Tau Population)
Query!
Assessment method [4]
0
0
The ADAS is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with AD. The cognitive subscale of the ADAS-cog consists of 13 items assessing areas of cognitive function most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, digit cancellation. The ADAS-Cog13 scale ranges from 0 to 85. Higher scores indicate greater disease severity. LS Mean value was adjusted for basis expansion terms (two terms), basis expansion term-by-treatment interaction, and covariates for age at baseline, pooled investigator, and baseline AchI/Memantine use.
Query!
Timepoint [4]
0
0
Baseline, Week 76
Query!
Secondary outcome [5]
0
0
Change From Baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) (Overall Population)
Query!
Assessment method [5]
0
0
CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. LS Mean value was adjusted for treatment, visit, treatment-by-visit interaction, and covariates for baseline score, baseline score-by-visit interaction, age at baseline, baseline tau category, pooled investigator, and baseline AchI/Memantine use.
Query!
Timepoint [5]
0
0
Baseline, Week 76
Query!
Secondary outcome [6]
0
0
Change From Baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) (Intermediate (Low-medium) Tau Population)
Query!
Assessment method [6]
0
0
CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. LS Mean value was adjusted for treatment, visit, treatment-by-visit interaction, and covariates for baseline score, baseline score-by-visit interaction, age at baseline, pooled investigator, and baseline AchI/Memantine use.
Query!
Timepoint [6]
0
0
Baseline, Week 76
Query!
Secondary outcome [7]
0
0
Change From Baseline on the Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living (ADCS-iADL) Score (Overall Population)
Query!
Assessment method [7]
0
0
The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities (instrumental activity items 6a, 7-23) of daily living by participants. The range for the ADCS-iADL is 0-59 with higher scores reflecting better performance. LS Mean value was adjusted for basis expansion terms (two terms), basis expansion term-by-treatment interaction, and covariates for age at baseline, pooled investigator, baseline tau level, and baseline AchI/Memantine use.
Query!
Timepoint [7]
0
0
Baseline, Week 76
Query!
Secondary outcome [8]
0
0
Change From Baseline on the Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living (ADCS-iADL) Score (Intermediate (Low-medium) Tau Population)
Query!
Assessment method [8]
0
0
The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities (instrumental activity items 6a, 7-23) of daily living by participants. The range for the ADCS-iADL is 0-59 with higher scores reflecting better performance. LS Mean value was adjusted for basis expansion terms (two terms), basis expansion term-by-treatment interaction, and covariates for age at baseline, pooled investigator, and baseline AchI/Memantine use.
Query!
Timepoint [8]
0
0
Baseline, Week 76
Query!
Secondary outcome [9]
0
0
Change From Baseline in Brain Amyloid Plaque Deposition as Measured by Amyloid Positron Emission Tomography (PET) Scan
Query!
Assessment method [9]
0
0
Amyloid PET scans at baseline and at 76 weeks after the first treatment were used to quantitatively estimate change in amyloid plaques. Quantitative amyloid burden was first formalized as the average Standardized Uptake Value Ratio (SUVR) in six predetermined cortical brain regions relative to the cerebellum as a reference region. Larger SUVR reflects the larger cortical amyloid burden relative to cerebellum. SUVR values were further calibrated to a centiloid (CL) scale. The Centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scan. LS Mean value was adjusted for treatment, visit, treatment-by-visit interaction, and covariates for baseline score, baseline score-by-visit interaction, baseline tau category, and age at baseline.
Query!
Timepoint [9]
0
0
Baseline, Week 76
Query!
Secondary outcome [10]
0
0
Change From Baseline in Brain Tau Deposition as Measured by Flortaucipir F18 PET Scan
Query!
Assessment method [10]
0
0
Flortaucipir PET imaging was used as a quantitative tau biomarker. Tau PET scans at baseline and at 76 weeks after the first treatment were used to quantitatively estimate change in aggregated tau neurofibrillary tangles (NFTs). Quantitative tau burden was formalized using Standardized Uptake Value Ratio (SUVR) in frontal lobe relative to the cerebellum gray as a reference region. Larger SUVR reflects larger tau burden in the frontal lobe relative to cerebellum gray. LS Mean value was adjusted for baseline score, screening tau category, age and treatment (Type III sum of squares).
Query!
Timepoint [10]
0
0
Baseline, Week 76
Query!
Secondary outcome [11]
0
0
Change From Baseline in Brain Volume as Measured by Volumetric Magnetic Resonance Imaging (vMRI)
Query!
Assessment method [11]
0
0
MRI scans at baseline and at 76 weeks after the first treatment were used to quantitatively estimate change in brain volume. Volumetric MRI parameters were measured in bilateral hippocampus, bilateral whole brain, and bilateral ventricles. LS Mean value was adjusted for treatment, visit, treatment-by-visit interaction, and covariates for baseline score, baseline tau category, and age at baseline.
Query!
Timepoint [11]
0
0
Baseline, Week 76
Query!
Secondary outcome [12]
0
0
Pharmacokinetics (PK): Average Serum Concentration at Steady State of Donanemab
Query!
Assessment method [12]
0
0
The average serum concentration at steady state, calculated as Cav = AUCtau/tau, where tau is the dosing interval (4 weeks). AUCtau/tau was assessed at week 12, 16, 24, 36, 52, 64 and Cav for the dosing interval from week 16 to week 20 is reported.
Query!
Timepoint [12]
0
0
Week 16 to week 20
Query!
Secondary outcome [13]
0
0
Number or Participants With Anti-Donanemab Antibodies
Query!
Assessment method [13]
0
0
Number of participants with treatment-emergent positive Anti-Donanemab antibodies was summarized by treatment group.
Query!
Timepoint [13]
0
0
Baseline through Week 76
Query!
Eligibility
Key inclusion criteria
* Gradual and progressive change in memory function reported by participants or informants for = 6 months
* MMSE score of 20 to 28 (inclusive) at baseline
* Meet 18F flortaucipir PET scan (central read) criteria - does not apply to safety cohort
* Meet 18F florbetapir PET scan (central read) criteria
* Have a study partner who will provide written informed consent to participate
Query!
Minimum age
60
Years
Query!
Query!
Maximum age
85
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Contraindication to MRI or PET scans
* Current treatment with immunoglobulin G (IgG) therapy
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
19/06/2020
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
22/08/2025
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1736
Query!
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Query!
Recruitment hospital [1]
0
0
Central Coast Neurosciences Research - Erina
Query!
Recruitment hospital [2]
0
0
St Vincent's Hospital - Sydney
Query!
Recruitment hospital [3]
0
0
HammondCare Greenwich Hospital - Sydney
Query!
Recruitment hospital [4]
0
0
KARA Institute for Neurological Diseases - Sydney
Query!
Recruitment hospital [5]
0
0
NeuroCentrix - Carlton
Query!
Recruitment hospital [6]
0
0
Delmont Private Hospital - Glen Iris
Query!
Recruitment hospital [7]
0
0
HammondCare - Malvern
Query!
Recruitment hospital [8]
0
0
The Alfred Hospital - Melbourne
Query!
Recruitment hospital [9]
0
0
The Royal Melbourne Hospital - Parkville
Query!
Recruitment postcode(s) [1]
0
0
2250 - Erina
Query!
Recruitment postcode(s) [2]
0
0
2010 - Sydney
Query!
Recruitment postcode(s) [3]
0
0
2065 - Sydney
Query!
Recruitment postcode(s) [4]
0
0
2113 - Sydney
Query!
Recruitment postcode(s) [5]
0
0
3053 - Carlton
Query!
Recruitment postcode(s) [6]
0
0
3146 - Glen Iris
Query!
Recruitment postcode(s) [7]
0
0
3144 - Malvern
Query!
Recruitment postcode(s) [8]
0
0
3004 - Melbourne
Query!
Recruitment postcode(s) [9]
0
0
3050 - Parkville
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arkansas
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Connecticut
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
District of Columbia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Florida
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Georgia
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Idaho
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Illinois
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Indiana
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Iowa
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Kansas
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Maine
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Massachusetts
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Michigan
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Mississippi
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Missouri
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Nevada
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
New Jersey
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
New York
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
North Carolina
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Ohio
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Oklahoma
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Oregon
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Pennsylvania
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Rhode Island
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
South Carolina
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Tennessee
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
Texas
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
Vermont
Query!
Country [32]
0
0
United States of America
Query!
State/province [32]
0
0
Virginia
Query!
Country [33]
0
0
United States of America
Query!
State/province [33]
0
0
Washington
Query!
Country [34]
0
0
Canada
Query!
State/province [34]
0
0
British Columbia
Query!
Country [35]
0
0
Canada
Query!
State/province [35]
0
0
Nova Scotia
Query!
Country [36]
0
0
Canada
Query!
State/province [36]
0
0
Ontario
Query!
Country [37]
0
0
Canada
Query!
State/province [37]
0
0
Quebec
Query!
Country [38]
0
0
Czechia
Query!
State/province [38]
0
0
Plzen-mesto
Query!
Country [39]
0
0
Czechia
Query!
State/province [39]
0
0
Praha 10
Query!
Country [40]
0
0
Czechia
Query!
State/province [40]
0
0
Praha 6
Query!
Country [41]
0
0
Czechia
Query!
State/province [41]
0
0
Stredoceský Kraj
Query!
Country [42]
0
0
Japan
Query!
State/province [42]
0
0
Aichi
Query!
Country [43]
0
0
Japan
Query!
State/province [43]
0
0
Chiba
Query!
Country [44]
0
0
Japan
Query!
State/province [44]
0
0
Hyogo
Query!
Country [45]
0
0
Japan
Query!
State/province [45]
0
0
Ibaraki
Query!
Country [46]
0
0
Japan
Query!
State/province [46]
0
0
Kanagawa
Query!
Country [47]
0
0
Japan
Query!
State/province [47]
0
0
Oita
Query!
Country [48]
0
0
Japan
Query!
State/province [48]
0
0
Okayama
Query!
Country [49]
0
0
Japan
Query!
State/province [49]
0
0
Osaka
Query!
Country [50]
0
0
Japan
Query!
State/province [50]
0
0
Tokyo
Query!
Country [51]
0
0
Japan
Query!
State/province [51]
0
0
Hiroshima
Query!
Country [52]
0
0
Japan
Query!
State/province [52]
0
0
Kyoto
Query!
Country [53]
0
0
Japan
Query!
State/province [53]
0
0
Tokushima
Query!
Country [54]
0
0
Netherlands
Query!
State/province [54]
0
0
Fryslân
Query!
Country [55]
0
0
Netherlands
Query!
State/province [55]
0
0
Noord-Brabant
Query!
Country [56]
0
0
Netherlands
Query!
State/province [56]
0
0
Noord-Holland
Query!
Country [57]
0
0
Netherlands
Query!
State/province [57]
0
0
Overijssel
Query!
Country [58]
0
0
Poland
Query!
State/province [58]
0
0
Dolnoslaskie
Query!
Country [59]
0
0
Poland
Query!
State/province [59]
0
0
Kujawsko-pomorskie
Query!
Country [60]
0
0
Poland
Query!
State/province [60]
0
0
Lubelskie
Query!
Country [61]
0
0
Poland
Query!
State/province [61]
0
0
Mazowieckie
Query!
Country [62]
0
0
Poland
Query!
State/province [62]
0
0
Malopolskie
Query!
Country [63]
0
0
Poland
Query!
State/province [63]
0
0
Podlaskie
Query!
Country [64]
0
0
Poland
Query!
State/province [64]
0
0
Pomorskie
Query!
Country [65]
0
0
Poland
Query!
State/province [65]
0
0
Wielkopolskie
Query!
Country [66]
0
0
Poland
Query!
State/province [66]
0
0
Zachodniopomorskie
Query!
Country [67]
0
0
Poland
Query!
State/province [67]
0
0
Slaskie
Query!
Country [68]
0
0
Puerto Rico
Query!
State/province [68]
0
0
Bayamon
Query!
Country [69]
0
0
Puerto Rico
Query!
State/province [69]
0
0
San Juan
Query!
Country [70]
0
0
United Kingdom
Query!
State/province [70]
0
0
Great Britain
Query!
Country [71]
0
0
United Kingdom
Query!
State/province [71]
0
0
London, City Of
Query!
Country [72]
0
0
United Kingdom
Query!
State/province [72]
0
0
Surrey
Query!
Country [73]
0
0
United Kingdom
Query!
State/province [73]
0
0
Birmingham
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Eli Lilly and Company
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The reason for this study is to see how safe and effective the study drug donanemab is in participants with early Alzheimer's disease. Additional participants will be enrolled to an addendum safety cohort. The participants will be administered open-label donanemab.
Query!
Trial website
https://clinicaltrials.gov/study/NCT04437511
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
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)
Query!
Address
0
0
Eli Lilly and Company
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
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.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
Query!
When will data be available (start and end dates)?
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.
Query!
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: http://vivli.org/
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/11/NCT04437511/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/11/NCT04437511/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT04437511