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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06653153




Registration number
NCT06653153
Ethics application status
Date submitted
21/10/2024
Date registered
22/10/2024

Titles & IDs
Public title
A Study of Remternetug (LY3372993) in Early Alzheimer's Disease (TRAILRUNNER-ALZ 3)
Scientific title
A Study of Remternetug Versus Placebo in Early Alzheimer's Disease Participants at Risk for Cognitive and Functional Decline
Secondary ID [1] 0 0
J1G-MC-LAKI
Secondary ID [2] 0 0
27183
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's 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 - Remternetug
Treatment: Drugs - Placebo

Experimental: Remternetug - Remternetug administered subcutaneously (SC).

Placebo comparator: Placebo - Placebo administered SC.


Treatment: Drugs: Remternetug
Administered SC

Treatment: Drugs: Placebo
Administered SC
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to Clinically Meaningful Progression as Measured by Clinical Dementia Rate (CDR)
Timepoint [1] 0 0
Baseline to Time to Event up to Week 255
Secondary outcome [1] 0 0
Change from Baseline in Clinical Dementia Rate Box Score (SB)
Timepoint [1] 0 0
Baseline, Week 255
Secondary outcome [2] 0 0
Change from Baseline in Montreal Cognitive Assessment (MoCA)
Timepoint [2] 0 0
Baseline, Week 255
Secondary outcome [3] 0 0
Change from Baseline in the Category Fluency - Language, Executive Function, Semantic Memory
Timepoint [3] 0 0
Baseline, Week 255
Secondary outcome [4] 0 0
Change from Baseline in the Continuous Paired Associate Learning (CPAL)
Timepoint [4] 0 0
Baseline, Week 255
Secondary outcome [5] 0 0
Change from Baseline in International Shopping List Test (ISLT) - Verbal Episodic Mem
Timepoint [5] 0 0
Baseline, Week 255
Secondary outcome [6] 0 0
Change from Baseline in International Daily Symbol Substitution Test-Medicines (iDSSTm) - Complex Attention Memory
Timepoint [6] 0 0
Baseline, Week 255
Secondary outcome [7] 0 0
Change from Baseline in Cogstate Brief Battery (CBB) - Psychomotor Function, Attention, Learning and Working Memory
Timepoint [7] 0 0
Baseline, Week 255
Secondary outcome [8] 0 0
Change from Baseline in Cognitive Function Index (CFI)
Timepoint [8] 0 0
Baseline, Week 255
Secondary outcome [9] 0 0
Change from Baseline in Mild Behavioral Impairment Checklist (MBI-C)
Timepoint [9] 0 0
Baseline, Week 255
Secondary outcome [10] 0 0
Change from Baseline in Alzheimer's Disease Cooperative Study (ADCS) Activities of Daily Living - Prevention Instrument (ADCS-ADL-PI)
Timepoint [10] 0 0
Baseline, Week 255
Secondary outcome [11] 0 0
Pharmacokinetics: Serum Concentrations of Remternetug
Timepoint [11] 0 0
Baseline through Week 255
Secondary outcome [12] 0 0
Number of Participants with Treatment Emergent Anti-Drug Antibodies (TE-ADAs)
Timepoint [12] 0 0
Baseline through Week 255

Eligibility
Key inclusion criteria
* Have a phosphorylated tau (P-tau) result consistent with the presence of amyloid pathology.
* Have a reliable study partner and backup study partner familiar with overall function and behavior, such as day-to-day activities and cognitive abilities.
* Have adequate literacy, vision, and hearing for neuropsychological testing at screening.
* Have a Mini Mental Status Exam (MMSE) score consistent with no to minimal cognitive impairment.
* Have a Functional Activities Questionnaire (FAQ) score consistent with no to minimal functional impairment.
* If currently receiving medications as symptomatic treatment for AD, dose has been stable for at least 30 days before screening.
Minimum age
55 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have dementia or significant other neurological disease that can affect cognition.
* Have current serious or unstable illnesses that in the investigator's opinion, could interfere with the analyses of the study.
* Have a history of cancer that, in the investigator's opinion, has a high risk of recurrence.
* Have a history of clinically significant multiple or severe drug allergies, or hypersensitivity reactions.
* Have a clinically important laboratory test result or other abnormality as determined by investigator, prior to randomization, that could be detrimental to the participant or could compromise the study.
* Have any contraindications for magnetic resonance imaging (MRI).
* Have a centrally read MRI that does not meets study entry criteria.

Prior or Current Therapies

* Have ever had prior treatment with a passive anti-amyloid immunotherapy.
* Have received active immunization against Aß in any other study.

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
24/10/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2030
Actual
Sample size
Target
1200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Paratus Clinical Research Canberra - Bruce
Recruitment hospital [2] 0 0
Paratus Clinical Research Western Sydney - Blacktown
Recruitment hospital [3] 0 0
Emeritus Research - Botany
Recruitment hospital [4] 0 0
GenesisCare - Maitland - East Maitland
Recruitment hospital [5] 0 0
Paratus Clinical Research Central Coast - Kanwal
Recruitment hospital [6] 0 0
Southern Neurology - Kogarah
Recruitment hospital [7] 0 0
KARA Institute for Neurological Diseases - Macquarie Park
Recruitment hospital [8] 0 0
St Vincent's Hospital - Sydney
Recruitment hospital [9] 0 0
USC Clinical Trials Sunshine Coast - Birtinya
Recruitment hospital [10] 0 0
Paratus Clinical Research Brisbane - Herston
Recruitment hospital [11] 0 0
The University of Queensland - Herston
Recruitment hospital [12] 0 0
Ipswich Hospital - Ipswich
Recruitment hospital [13] 0 0
USC Clinical Trials Brisbane (South Bank) - South Brisbane
Recruitment hospital [14] 0 0
Fusion Clinical Research - Norwood
Recruitment hospital [15] 0 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [16] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [17] 0 0
Emeritus Research - Camberwell
Recruitment hospital [18] 0 0
Austin Health - Ivanhoe
Recruitment hospital [19] 0 0
HammondCare - Malvern
Recruitment hospital [20] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment hospital [21] 0 0
Alzheimer's Research Australia - Nedlands
Recruitment postcode(s) [1] 0 0
2617 - Bruce
Recruitment postcode(s) [2] 0 0
2148 - Blacktown
Recruitment postcode(s) [3] 0 0
2019 - Botany
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2323 - East Maitland
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2259 - Kanwal
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2217 - Kogarah
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2113 - Macquarie Park
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2010 - Sydney
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4575 - Birtinya
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4010 - Herston
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4029 - Herston
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4305 - Ipswich
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4101 - South Brisbane
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5067 - Norwood
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5011 - Woodville
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3128 - Box Hill
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3124 - Camberwell
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3079 - Ivanhoe
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3144 - Malvern
Recruitment postcode(s) [20] 0 0
3050 - Parkville
Recruitment postcode(s) [21] 0 0
6009 - Nedlands
Recruitment outside Australia
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Arizona
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Illinois
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Indiana
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Iowa
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Kansas
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Louisiana
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Madrid
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País Vasco
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Taipei
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Taoyuan
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United Kingdom
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Bath And North East Somerset
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England
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London, City Of
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Oxfordshire
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United Kingdom
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Staffordshire
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United Kingdom
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Wirral
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Birmingham
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Manchester
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United Kingdom
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Newcastle upon Tyne

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
3176154559
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 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/NCT06653153