Trial Review

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/NCT06653153




Registration number
NCT06653153
Ethics application status
Date submitted
21/10/2024
Date registered
22/10/2024
Date last updated
8/07/2025

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)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Emeritus Research - Botany
Recruitment hospital [2] 0 0
GenesisCare - Maitland - East Maitland
Recruitment hospital [3] 0 0
Southern Neurology - Kogarah
Recruitment hospital [4] 0 0
KARA Institute for Neurological Diseases - Macquarie Park
Recruitment hospital [5] 0 0
St Vincent's Hospital - Sydney
Recruitment hospital [6] 0 0
USC Clinical Trials Sunshine Coast - Birtinya
Recruitment hospital [7] 0 0
The University of Queensland - Herston
Recruitment hospital [8] 0 0
Ipswich Hospital - Ipswich
Recruitment hospital [9] 0 0
USC Clinical Trials Brisbane (South Bank) - South Brisbane
Recruitment hospital [10] 0 0
Fusion Clinical Research - Norwood
Recruitment hospital [11] 0 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [12] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [13] 0 0
Emeritus Research - Camberwell
Recruitment hospital [14] 0 0
Austin Health - Ivanhoe
Recruitment hospital [15] 0 0
HammondCare - Malvern
Recruitment hospital [16] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2019 - Botany
Recruitment postcode(s) [2] 0 0
2323 - East Maitland
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
2113 - Macquarie Park
Recruitment postcode(s) [5] 0 0
2010 - Sydney
Recruitment postcode(s) [6] 0 0
4575 - Birtinya
Recruitment postcode(s) [7] 0 0
4029 - Herston
Recruitment postcode(s) [8] 0 0
4305 - Ipswich
Recruitment postcode(s) [9] 0 0
4101 - South Brisbane
Recruitment postcode(s) [10] 0 0
5067 - Norwood
Recruitment postcode(s) [11] 0 0
5011 - Woodville
Recruitment postcode(s) [12] 0 0
3128 - Box Hill
Recruitment postcode(s) [13] 0 0
3124 - Camberwell
Recruitment postcode(s) [14] 0 0
3079 - Ivanhoe
Recruitment postcode(s) [15] 0 0
3144 - Malvern
Recruitment postcode(s) [16] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Iowa
Country [12] 0 0
United States of America
State/province [12] 0 0
Kansas
Country [13] 0 0
United States of America
State/province [13] 0 0
Louisiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Maine
Country [15] 0 0
United States of America
State/province [15] 0 0
Maryland
Country [16] 0 0
United States of America
State/province [16] 0 0
Massachusetts
Country [17] 0 0
United States of America
State/province [17] 0 0
Michigan
Country [18] 0 0
United States of America
State/province [18] 0 0
Minnesota
Country [19] 0 0
United States of America
State/province [19] 0 0
Mississippi
Country [20] 0 0
United States of America
State/province [20] 0 0
Missouri
Country [21] 0 0
United States of America
State/province [21] 0 0
Nebraska
Country [22] 0 0
United States of America
State/province [22] 0 0
Nevada
Country [23] 0 0
United States of America
State/province [23] 0 0
New Jersey
Country [24] 0 0
United States of America
State/province [24] 0 0
New Mexico
Country [25] 0 0
United States of America
State/province [25] 0 0
North Carolina
Country [26] 0 0
United States of America
State/province [26] 0 0
Ohio
Country [27] 0 0
United States of America
State/province [27] 0 0
Oregon
Country [28] 0 0
United States of America
State/province [28] 0 0
Pennsylvania
Country [29] 0 0
United States of America
State/province [29] 0 0
Rhode Island
Country [30] 0 0
United States of America
State/province [30] 0 0
South Carolina
Country [31] 0 0
United States of America
State/province [31] 0 0
Tennessee
Country [32] 0 0
United States of America
State/province [32] 0 0
Texas
Country [33] 0 0
United States of America
State/province [33] 0 0
Virginia
Country [34] 0 0
United States of America
State/province [34] 0 0
Washington
Country [35] 0 0
Argentina
State/province [35] 0 0
Buenos Aires
Country [36] 0 0
Argentina
State/province [36] 0 0
Ciudad Autónoma De Buenos Aires
Country [37] 0 0
Argentina
State/province [37] 0 0
Santa Fe
Country [38] 0 0
Argentina
State/province [38] 0 0
Tucumán
Country [39] 0 0
Argentina
State/province [39] 0 0
Ciudad Autónoma de Buenos Aires
Country [40] 0 0
Argentina
State/province [40] 0 0
Córdoba
Country [41] 0 0
Argentina
State/province [41] 0 0
Mendoza
Country [42] 0 0
Brazil
State/province [42] 0 0
Ceará
Country [43] 0 0
Brazil
State/province [43] 0 0
Distrito Federal
Country [44] 0 0
Brazil
State/province [44] 0 0
Espírito Santo
Country [45] 0 0
Brazil
State/province [45] 0 0
Paraná
Country [46] 0 0
Brazil
State/province [46] 0 0
Rio Grande Do Sul
Country [47] 0 0
Brazil
State/province [47] 0 0
Santa Catarina
Country [48] 0 0
Brazil
State/province [48] 0 0
Sergipe
Country [49] 0 0
Brazil
State/province [49] 0 0
São Paulo
Country [50] 0 0
Brazil
State/province [50] 0 0
Rio de Janeiro
Country [51] 0 0
Brazil
State/province [51] 0 0
Rio De Janeiro
Country [52] 0 0
Canada
State/province [52] 0 0
British Columbia
Country [53] 0 0
Canada
State/province [53] 0 0
Ontario
Country [54] 0 0
Canada
State/province [54] 0 0
Quebec
Country [55] 0 0
China
State/province [55] 0 0
Anhui
Country [56] 0 0
China
State/province [56] 0 0
Beijing
Country [57] 0 0
China
State/province [57] 0 0
Guangdong
Country [58] 0 0
China
State/province [58] 0 0
Hebei
Country [59] 0 0
China
State/province [59] 0 0
Henan
Country [60] 0 0
China
State/province [60] 0 0
Hunan
Country [61] 0 0
China
State/province [61] 0 0
Jiangsu
Country [62] 0 0
China
State/province [62] 0 0
Jiangxi
Country [63] 0 0
China
State/province [63] 0 0
Jilin
Country [64] 0 0
China
State/province [64] 0 0
Shaanxi
Country [65] 0 0
China
State/province [65] 0 0
Shandong
Country [66] 0 0
China
State/province [66] 0 0
Shanghai
Country [67] 0 0
China
State/province [67] 0 0
Sichuan
Country [68] 0 0
China
State/province [68] 0 0
Tianjin
Country [69] 0 0
Japan
State/province [69] 0 0
Aichi
Country [70] 0 0
Japan
State/province [70] 0 0
Ehime
Country [71] 0 0
Japan
State/province [71] 0 0
Hyogo
Country [72] 0 0
Japan
State/province [72] 0 0
Kanagawa
Country [73] 0 0
Japan
State/province [73] 0 0
Osaka
Country [74] 0 0
Japan
State/province [74] 0 0
Saitama
Country [75] 0 0
Japan
State/province [75] 0 0
Tokyo
Country [76] 0 0
Japan
State/province [76] 0 0
Fukuoka
Country [77] 0 0
Japan
State/province [77] 0 0
Kyoto
Country [78] 0 0
Korea, Republic of
State/province [78] 0 0
Chungcheongbuk-do [Chungbuk]
Country [79] 0 0
Korea, Republic of
State/province [79] 0 0
Incheon-gwangyeoksi [Incheon]
Country [80] 0 0
Korea, Republic of
State/province [80] 0 0
Jeju-teukbyeoljachido [Jeju]
Country [81] 0 0
Korea, Republic of
State/province [81] 0 0
Kang-won-do
Country [82] 0 0
Korea, Republic of
State/province [82] 0 0
Kwangju-Kwangyokshi
Country [83] 0 0
Korea, Republic of
State/province [83] 0 0
Kyonggi-do
Country [84] 0 0
Korea, Republic of
State/province [84] 0 0
Pusan-Kwangyokshi
Country [85] 0 0
Korea, Republic of
State/province [85] 0 0
Seoul-teukbyeolsi [Seoul]
Country [86] 0 0
Mexico
State/province [86] 0 0
Distrito Federal
Country [87] 0 0
Mexico
State/province [87] 0 0
Jalisco
Country [88] 0 0
Mexico
State/province [88] 0 0
Nuevo León
Country [89] 0 0
Mexico
State/province [89] 0 0
Oaxaca
Country [90] 0 0
Mexico
State/province [90] 0 0
Yucatán
Country [91] 0 0
Mexico
State/province [91] 0 0
Aguascalientes
Country [92] 0 0
Mexico
State/province [92] 0 0
Chihuahua
Country [93] 0 0
Puerto Rico
State/province [93] 0 0
Bayamon
Country [94] 0 0
Puerto Rico
State/province [94] 0 0
San Juan
Country [95] 0 0
Spain
State/province [95] 0 0
Andalucía
Country [96] 0 0
Spain
State/province [96] 0 0
Barcelona [Barcelona]
Country [97] 0 0
Spain
State/province [97] 0 0
Catalunya [Cataluña]
Country [98] 0 0
Spain
State/province [98] 0 0
Madrid
Country [99] 0 0
Spain
State/province [99] 0 0
País Vasco
Country [100] 0 0
Taiwan
State/province [100] 0 0
Changhua
Country [101] 0 0
Taiwan
State/province [101] 0 0
Kaohsiung
Country [102] 0 0
Taiwan
State/province [102] 0 0
New Taipei
Country [103] 0 0
Taiwan
State/province [103] 0 0
Yunlin
Country [104] 0 0
Taiwan
State/province [104] 0 0
Taichung
Country [105] 0 0
Taiwan
State/province [105] 0 0
Tainan
Country [106] 0 0
Taiwan
State/province [106] 0 0
Taipei
Country [107] 0 0
Taiwan
State/province [107] 0 0
Taoyuan
Country [108] 0 0
United Kingdom
State/province [108] 0 0
Bath And North East Somerset
Country [109] 0 0
United Kingdom
State/province [109] 0 0
Cornwall
Country [110] 0 0
United Kingdom
State/province [110] 0 0
Devon
Country [111] 0 0
United Kingdom
State/province [111] 0 0
Edinburgh, City Of
Country [112] 0 0
United Kingdom
State/province [112] 0 0
England
Country [113] 0 0
United Kingdom
State/province [113] 0 0
Great Britain
Country [114] 0 0
United Kingdom
State/province [114] 0 0
Hampshire
Country [115] 0 0
United Kingdom
State/province [115] 0 0
Lancashire
Country [116] 0 0
United Kingdom
State/province [116] 0 0
London, City Of
Country [117] 0 0
United Kingdom
State/province [117] 0 0
Oxfordshire
Country [118] 0 0
United Kingdom
State/province [118] 0 0
Wirral
Country [119] 0 0
United Kingdom
State/province [119] 0 0
Birmingham
Country [120] 0 0
United Kingdom
State/province [120] 0 0
Manchester

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


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