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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04437511




Registration number
NCT04437511
Ethics application status
Date submitted
17/06/2020
Date registered
18/06/2020
Date last updated
4/05/2021

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 - Donanemab given intravenously (IV).

Placebo Comparator: Placebo - 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) - Change from Baseline on the iADRS in participants with early symptomatic AD with demonstrated presence of low-medium tau pathology.
Timepoint [1] 0 0
Baseline, Up to Week 76
Secondary outcome [1] 0 0
Change from Baseline on the integrated Alzheimer's Disease Rating Scale (iADRS) - Change from Baseline on the iADRS in participants with early symptomatic AD with demonstrated presence of high tau pathology and in the overall population.
Timepoint [1] 0 0
Baseline, Up to Week 76
Secondary outcome [2] 0 0
Change from Baseline on the Mini Mental State Examination (MMSE) Score - Change from Baseline on the MMSE Score in participants with early symptomatic AD with demonstrated presence of low-medium tau pathology, high tau pathology, and in the overall population.
Timepoint [2] 0 0
Baseline, Up to Week 76
Secondary outcome [3] 0 0
Change from Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) - Change from Baseline on the ADAS-Cog13 in participants with early symptomatic AD with demonstrated presence of low-medium tau pathology, high tau pathology, and in the overall population.
Timepoint [3] 0 0
Baseline, Up to Week 76
Secondary outcome [4] 0 0
Change from Baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) - Change from Baseline on the CDR-SB in participants with early symptomatic AD with demonstrated presence of low-medium tau pathology, high tau pathology, and in the overall population.
Timepoint [4] 0 0
Baseline, Up to Week 76
Secondary outcome [5] 0 0
Change from Baseline on the Alzheimer's Disease Cooperative Study - instrumental Activities of Daily Living (ADCS-iADL) Score - Change from Baseline on the ADCS-iADL Score in participants with early symptomatic AD with demonstrated presence of low-medium tau pathology, high tau pathology, and in the overall population.
Timepoint [5] 0 0
Baseline, Up to Week 76
Secondary outcome [6] 0 0
Change from Baseline in Brain Amyloid Plaque Deposition as Measured by Florbetapir F18 Positron Emission Tomography (PET) Scan - Change from Baseline in Brain Amyloid Plaque Deposition as measured by Florbetapir F18 PET Scan
Timepoint [6] 0 0
Baseline, Up to Week 76
Secondary outcome [7] 0 0
Change from Baseline in Brain Tau Deposition as Measured by Flortaucipir F18 PET Scan - Change from Baseline in Brain Tau Deposition as Measured by Flortaucipir F18 PET Scan
Timepoint [7] 0 0
Baseline, Up to Week 76
Secondary outcome [8] 0 0
Change from Baseline in Brain Volume as Measured by volumetric Magnetic Resonance Imaging (vMRI) - Change from Baseline in Brain Volume as Measured by vMRI
Timepoint [8] 0 0
Baseline, Up to Week 76
Secondary outcome [9] 0 0
Pharmacokinetics (PK): Average Serum Concentration at Steady State of Donanemab - PK: Average Serum Concentration at steady state of Donanemab
Timepoint [9] 0 0
Baseline through Week 76
Secondary outcome [10] 0 0
Number or Participants with Anti-Donanemab Antibodies - Number or Participants with Anti-Donanemab Antibodies
Timepoint [10] 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

- 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
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
St. Vincents Hospital Sydney - Darlinghurst
Recruitment hospital [2] 0 0
Central Coast Neurosciences Research - Erina
Recruitment hospital [3] 0 0
KaRa Institute of Neurological Diseases - Macquarie Park
Recruitment hospital [4] 0 0
HammondCare - Sydney
Recruitment hospital [5] 0 0
Delmont Private Hospital - Glen Iris
Recruitment hospital [6] 0 0
HammondCare - Malvern
Recruitment hospital [7] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [8] 0 0
NeuroCentrix - Noble Park
Recruitment hospital [9] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2250 - Erina
Recruitment postcode(s) [3] 0 0
2113 - Macquarie Park
Recruitment postcode(s) [4] 0 0
2065 - Sydney
Recruitment postcode(s) [5] 0 0
3146 - Glen Iris
Recruitment postcode(s) [6] 0 0
3144 - Malvern
Recruitment postcode(s) [7] 0 0
3004 - Melbourne
Recruitment postcode(s) [8] 0 0
3174 - Noble Park
Recruitment postcode(s) [9] 0 0
3050 - Parkville
Recruitment outside Australia
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Alabama
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT04437511
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
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Address 0 0
Country 0 0
Phone 0 0
1-317-615-4559
Fax 0 0
Email 0 0
Clinicaltrials.gov@lilly.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04437511