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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)
Scientific title
Assessment of Safety, Tolerability, and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease
Secondary ID [1] 0 0
I5T-MC-AACI
Secondary ID [2] 0 0
17737
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Overall Population)
Timepoint [1] 0 0
Baseline, Week 76
Primary outcome [2] 0 0
Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Intermediate (Low-medium) Tau Population)
Timepoint [2] 0 0
Baseline, Week 76
Secondary outcome [1] 0 0
Change From Baseline on the Mini Mental State Examination (MMSE) Score (Overall Population)
Timepoint [1] 0 0
Baseline, Week 76
Secondary outcome [2] 0 0
Change From Baseline on the Mini Mental State Examination (MMSE) Score (Intermediate (Low-medium) Tau Population)
Timepoint [2] 0 0
Baseline, Week 76
Secondary outcome [3] 0 0
Change From Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) (Overall Population)
Timepoint [3] 0 0
Baseline, Week 76
Secondary outcome [4] 0 0
Change From Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) (Intermediate (Low-medium) Tau Population)
Timepoint [4] 0 0
Baseline, Week 76
Secondary outcome [5] 0 0
Change From Baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) (Overall Population)
Timepoint [5] 0 0
Baseline, Week 76
Secondary outcome [6] 0 0
Change From Baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) (Intermediate (Low-medium) Tau Population)
Timepoint [6] 0 0
Baseline, Week 76
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)
Timepoint [7] 0 0
Baseline, Week 76
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)
Timepoint [8] 0 0
Baseline, Week 76
Secondary outcome [9] 0 0
Change From Baseline in Brain Amyloid Plaque Deposition as Measured by Amyloid Positron Emission Tomography (PET) Scan
Timepoint [9] 0 0
Baseline, Week 76
Secondary outcome [10] 0 0
Change From Baseline in Brain Tau Deposition as Measured by Flortaucipir F18 PET Scan
Timepoint [10] 0 0
Baseline, Week 76
Secondary outcome [11] 0 0
Change From Baseline in Brain Volume as Measured by Volumetric Magnetic Resonance Imaging (vMRI)
Timepoint [11] 0 0
Baseline, Week 76
Secondary outcome [12] 0 0
Pharmacokinetics (PK): Average Serum Concentration at Steady State of Donanemab
Timepoint [12] 0 0
Week 16 to week 20
Secondary outcome [13] 0 0
Number or Participants With Anti-Donanemab Antibodies
Timepoint [13] 0 0
Baseline through Week 76

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
Minimum age
60 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Contraindication to MRI or PET scans
* Current treatment with immunoglobulin G (IgG) therapy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/06/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
22/08/2025
Actual
Sample size
Target
Accrual to date
Final
1736
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Central Coast Neurosciences Research - Erina
Recruitment hospital [2] 0 0
St Vincent's Hospital - Sydney
Recruitment hospital [3] 0 0
HammondCare Greenwich Hospital - Sydney
Recruitment hospital [4] 0 0
KARA Institute for Neurological Diseases - Sydney
Recruitment hospital [5] 0 0
NeuroCentrix - Carlton
Recruitment hospital [6] 0 0
Delmont Private Hospital - Glen Iris
Recruitment hospital [7] 0 0
HammondCare - Malvern
Recruitment hospital [8] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [9] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2250 - Erina
Recruitment postcode(s) [2] 0 0
2010 - Sydney
Recruitment postcode(s) [3] 0 0
2065 - Sydney
Recruitment postcode(s) [4] 0 0
2113 - Sydney
Recruitment postcode(s) [5] 0 0
3053 - Carlton
Recruitment postcode(s) [6] 0 0
3146 - Glen Iris
Recruitment postcode(s) [7] 0 0
3144 - Malvern
Recruitment postcode(s) [8] 0 0
3004 - Melbourne
Recruitment postcode(s) [9] 0 0
3050 - Parkville
Recruitment outside Australia
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District of Columbia
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Surrey
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Birmingham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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)
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.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://vivli.org/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04437511