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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05508789




Registration number
NCT05508789
Ethics application status
Date submitted
18/08/2022
Date registered
19/08/2022

Titles & IDs
Public title
A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)
Scientific title
Global Study to Investigate Safety and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease
Secondary ID [1] 0 0
I5T-MC-AACO
Secondary ID [2] 0 0
18442
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer Disease 0 0
Dementia 0 0
Brain Diseases 0 0
Central Nervous System Diseases 0 0
Nervous System Diseases 0 0
Tauopathies 0 0
Neurodegenerative Diseases 0 0
Neurocognitive Disorders 0 0
Mental Disorders 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias
Neurological 0 0 0 0
Neurodegenerative diseases
Neurological 0 0 0 0
Other neurological disorders
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Donanemab
Treatment: Drugs - Placebo

Experimental: Donanemab - Participants will receive donanemab intravenously (IV)

Placebo comparator: Placebo - Participants will receive placebo IV


Treatment: Drugs: Donanemab
Administered IV

Treatment: Drugs: Placebo
Administered 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)
Timepoint [1] 0 0
Baseline, Week 76
Secondary outcome [1] 0 0
Change from Baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB)
Timepoint [1] 0 0
Baseline, Week 76
Secondary outcome [2] 0 0
Change from Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale ADAS-Cog13 Score
Timepoint [2] 0 0
Baseline, Week 76
Secondary outcome [3] 0 0
Change from Baseline on the Alzheimer's Disease Cooperative Study - instrumental Activities of Daily Living ADCS-iADL Score
Timepoint [3] 0 0
Baseline, Week 76
Secondary outcome [4] 0 0
Change from Baseline on the Mini Mental State Examination (MMSE) Score
Timepoint [4] 0 0
Baseline, Week 76
Secondary outcome [5] 0 0
Change from Baseline in Amyloid Plaque Deposition as by Florbetapir F18 Positron Emission Tomography (PET) Scan
Timepoint [5] 0 0
Baseline, Week 76
Secondary outcome [6] 0 0
Pharmacokinetics (PK): Average Serum Concentration of Donanemab
Timepoint [6] 0 0
Baseline to Week 76
Secondary outcome [7] 0 0
Number of Participants with Treatment-Emergent Anti-Drug Antibodies (ADAs)
Timepoint [7] 0 0
Week 76
Secondary outcome [8] 0 0
Change from Baseline in Quality of Life in Alzheimer's Disease (QOL-AD)
Timepoint [8] 0 0
Baseline, Week 76
Secondary outcome [9] 0 0
Change from Baseline in Resource Utilization in Dementia - Lite Version (RUD-Lite)
Timepoint [9] 0 0
Baseline, Week 76
Secondary outcome [10] 0 0
Change from Baseline in Neuropsychiatric Inventory (NPI)
Timepoint [10] 0 0
Baseline, Week 76

Eligibility
Key inclusion criteria
* Gradual and progressive change in memory function reported by the participant or informant for =6 months
* A MMSE score of 20 to 28 (inclusive) at Day 601 or 1.
* Meet flortaucipir F18 scan (central read) criteria
* Meet florbetapir F18 scan (central read) criteria
* 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 the study or be available by telephone at designated times.
* A second study partner may serve as backup. The study partner(s) is/are required to accompany the participant for signing consent. The study partner must be present on all days the cognitive and functional scales are administered.
* If a participant has a second study partner, it is preferred that 1 study partner be primarily responsible for the CDR and the ADCS-ADL assessments.
* Days requiring the following assessments and scales must have a study partner available by telephone if not accompanying participant for the following assessments

* AEs and concomitant medications
* CDR, and
* ADCS-ADL
* Stable concomitant symptomatic AD medications and other medications that may impact cognition for at least approximately 30 days prior to randomization.
Minimum age
60 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has significant neurological disease affect 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; or has a life expectancy of <24 months.
* History of cancer within the last 5 years, except of non-metastatic basal and/or squamous cell carcinoma of the skin, in situ cervical cancer, nonprogressive prostate cancer, or other cancers with low risk of recurrence or spread.
* Contraindication to MRI or PET scans

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
10/10/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/04/2027
Actual
Sample size
Target
1500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Emeritus Research - Botany
Recruitment hospital [2] 0 0
Central Coast Neurosciences Research - Erina
Recruitment hospital [3] 0 0
Southern Neurology - Kogarah
Recruitment hospital [4] 0 0
St Vincent's Hospital - Sydney
Recruitment hospital [5] 0 0
KARA Institute for Neurological Diseases - Sydney
Recruitment hospital [6] 0 0
Central Coast Neurosciences Research (Tumbi Umbi) - Tumbi Umbi
Recruitment hospital [7] 0 0
The Prince Charles Hospital - Brisbane
Recruitment hospital [8] 0 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [9] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [10] 0 0
NeuroCentrix - Carlton
Recruitment hospital [11] 0 0
Austin Health - Ivanhoe
Recruitment hospital [12] 0 0
HammondCare - Malvern
Recruitment hospital [13] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [14] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment hospital [15] 0 0
Australian Alzheimer's Research Foundation Inc. - Nedlands
Recruitment hospital [16] 0 0
Neurodegenerative Disorders Research - Perth
Recruitment postcode(s) [1] 0 0
2019 - Botany
Recruitment postcode(s) [2] 0 0
2250 - Erina
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
2010 - Sydney
Recruitment postcode(s) [5] 0 0
2113 - Sydney
Recruitment postcode(s) [6] 0 0
2261 - Tumbi Umbi
Recruitment postcode(s) [7] 0 0
4032 - Brisbane
Recruitment postcode(s) [8] 0 0
5011 - Woodville
Recruitment postcode(s) [9] 0 0
3128 - Box Hill
Recruitment postcode(s) [10] 0 0
3053 - Carlton
Recruitment postcode(s) [11] 0 0
3079 - Ivanhoe
Recruitment postcode(s) [12] 0 0
3144 - Malvern
Recruitment postcode(s) [13] 0 0
3004 - Melbourne
Recruitment postcode(s) [14] 0 0
3050 - Parkville
Recruitment postcode(s) [15] 0 0
6009 - Nedlands
Recruitment postcode(s) [16] 0 0
6005 - Perth
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Ciudad Autónoma De Buenos Aires
Country [3] 0 0
Argentina
State/province [3] 0 0
Santa Fe
Country [4] 0 0
Argentina
State/province [4] 0 0
Ciudad Autónoma de Buenos Aires
Country [5] 0 0
China
State/province [5] 0 0
Beijing
Country [6] 0 0
China
State/province [6] 0 0
Chongqing
Country [7] 0 0
China
State/province [7] 0 0
Fujian
Country [8] 0 0
China
State/province [8] 0 0
Guangdong
Country [9] 0 0
China
State/province [9] 0 0
Hebei
Country [10] 0 0
China
State/province [10] 0 0
Heilongjiang
Country [11] 0 0
China
State/province [11] 0 0
Hubei
Country [12] 0 0
China
State/province [12] 0 0
Hunan
Country [13] 0 0
China
State/province [13] 0 0
Jiangsu
Country [14] 0 0
China
State/province [14] 0 0
Jiangxi
Country [15] 0 0
China
State/province [15] 0 0
Jilin
Country [16] 0 0
China
State/province [16] 0 0
Shaanxi
Country [17] 0 0
China
State/province [17] 0 0
Shandong
Country [18] 0 0
China
State/province [18] 0 0
Shanghai
Country [19] 0 0
China
State/province [19] 0 0
Sichuan
Country [20] 0 0
China
State/province [20] 0 0
Tianjin
Country [21] 0 0
China
State/province [21] 0 0
Zhejiang
Country [22] 0 0
China
State/province [22] 0 0
Wuhan
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Incheon-gwangyeoksi [Incheon]
Country [24] 0 0
Korea, Republic of
State/province [24] 0 0
Kwangju-Kwangyokshi
Country [25] 0 0
Korea, Republic of
State/province [25] 0 0
Kyonggi-do
Country [26] 0 0
Korea, Republic of
State/province [26] 0 0
Pusan-Kwangyokshi
Country [27] 0 0
Korea, Republic of
State/province [27] 0 0
Seoul-teukbyeolsi [Seoul]
Country [28] 0 0
Korea, Republic of
State/province [28] 0 0
Taejon-Kwangyokshi
Country [29] 0 0
Taiwan
State/province [29] 0 0
Kaohsiung
Country [30] 0 0
Taiwan
State/province [30] 0 0
New Taipei
Country [31] 0 0
Taiwan
State/province [31] 0 0
Taipei
Country [32] 0 0
Taiwan
State/province [32] 0 0
Yunlin
Country [33] 0 0
Taiwan
State/province [33] 0 0
Taichung
Country [34] 0 0
Taiwan
State/province [34] 0 0
Tainan
Country [35] 0 0
Taiwan
State/province [35] 0 0
Taoyuan
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Bristol, City Of
Country [37] 0 0
United Kingdom
State/province [37] 0 0
East Sussex
Country [38] 0 0
United Kingdom
State/province [38] 0 0
England
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Hammersmith And Fulham
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Hampshire
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Lancashire
Country [42] 0 0
United Kingdom
State/province [42] 0 0
London, City Of
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Nottingham
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Reading
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Bath
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Birmingham
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Plymouth

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
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
[email protected]
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 European Union (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?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05508789