Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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/NCT06544616




Registration number
NCT06544616
Ethics application status
Date submitted
6/08/2024
Date registered
9/08/2024
Date last updated
26/10/2024

Titles & IDs
Public title
A Study of JNJ-64042056 in Participants With Preclinical Alzheimer's Disease
Scientific title
A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study, to Assess Efficacy, Safety and Immunogenicity of JNJ-64042056, a Phosphorylated Tau Targeted Active Immunotherapy, in Participants With Preclinical Alzheimer's Disease
Secondary ID [1] 0 0
2023-505096-68-00
Secondary ID [2] 0 0
64042056ALZ2001
Universal Trial Number (UTN)
Trial acronym
Retain
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preclinical 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 - JNJ-64042056
Treatment: Drugs - Placebo

Experimental: Arm A: JNJ-64042056 - Participants will receive intramuscular (IM) injection of JNJ-64042056 from Week 0 until Week 180.

Placebo comparator: Arm B: Placebo - Participants will receive IM injection of placebo from Week 0 until Week 180.


Treatment: Drugs: JNJ-64042056
JNJ-64042056 will be administered intramuscularly.

Treatment: Drugs: Placebo
Placebo will be administered intramuscularly.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Preclinical Alzheimer's Disease Cognitive Composite 5 (PACC-5) Total Scores up to Week 206
Timepoint [1] 0 0
Baseline up to Week 206
Secondary outcome [1] 0 0
Change From Baseline in Brain tau Burden as Measured by tau PET
Timepoint [1] 0 0
Baseline and Weeks 102, 154 and 206
Secondary outcome [2] 0 0
Change From Baseline in PACC-5 Individual Domain Scores
Timepoint [2] 0 0
Baseline up to Week 206
Secondary outcome [3] 0 0
Time to Event of Clinical Progression as Measured by Clinical Dementia Rating-Global Score (CDR-GS)
Timepoint [3] 0 0
Baseline up to Week 206
Secondary outcome [4] 0 0
Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Scores
Timepoint [4] 0 0
Baseline up to Week 206
Secondary outcome [5] 0 0
Change from Baseline in Tau PET Standardized Uptake Value Ratio (SUVR) Biomarkers (tau Naive Composite ROI and Other ROIs)
Timepoint [5] 0 0
Baseline up to Week 206
Secondary outcome [6] 0 0
Change From Baseline in p217+tau
Timepoint [6] 0 0
Baseline up to Week 206
Secondary outcome [7] 0 0
Change From Baseline in PACC-5 Total Score
Timepoint [7] 0 0
Baseline up to Week 180
Secondary outcome [8] 0 0
Change From Baseline in Brain Tau Burden as Measured by Tau PET in Other ROI
Timepoint [8] 0 0
Baseline up to Week 206
Secondary outcome [9] 0 0
Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living -Prevention Instrument (ADCS-ADL-PI)
Timepoint [9] 0 0
Baseline up to Week 206
Secondary outcome [10] 0 0
Change From Baseline in Mild Behavioral Impairment Checklist (MBI-C) Score
Timepoint [10] 0 0
Baseline up to Week 206
Secondary outcome [11] 0 0
Change From Baseline in the Quality of Life- Alzheimer's Disease (QoL-AD)
Timepoint [11] 0 0
Baseline up to Week 206
Secondary outcome [12] 0 0
Change From Baseline in European Quality of Life-5 Dimensions 5-Levels (EQ-5D-5L) Score
Timepoint [12] 0 0
Baseline up to Week 206
Secondary outcome [13] 0 0
Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite) Score
Timepoint [13] 0 0
Baseline up to Week 206
Secondary outcome [14] 0 0
Levels of IgG Titers Against Enriched Paired Helical Filaments (ePHF), p-tau and tau in Serum
Timepoint [14] 0 0
Up to Week 206
Secondary outcome [15] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Timepoint [15] 0 0
Up to Week 208
Secondary outcome [16] 0 0
Number of Participants With Reactogenicity
Timepoint [16] 0 0
Up to Week 182
Secondary outcome [17] 0 0
Change from Baseline in Vital Signs
Timepoint [17] 0 0
Baseline up to Week 206
Secondary outcome [18] 0 0
Change From Baseline in Clinical Laboratory Values
Timepoint [18] 0 0
Baseline up to Week 206
Secondary outcome [19] 0 0
Change from Baseline in Electrocardiogram (ECG) Values
Timepoint [19] 0 0
Baseline up to Week 206
Secondary outcome [20] 0 0
Change From Baseline in Columbia-Suicidality Severity Rating Scale (C-SSRS)
Timepoint [20] 0 0
Baseline up to Week 206
Secondary outcome [21] 0 0
Change From Baseline in Magnetic Resonance Imaging (MRI) Findings
Timepoint [21] 0 0
Baseline up to Week 206

Eligibility
Key inclusion criteria
* Elevated brain tau pathology defined as Braak 3 region of interest standardized uptake value ratio (ROI SUVR) greater than (>) 1.1 on a screening tau PET scan, reviewed centrally by a qualified reader
* Clinical Dementia Rating (CDR) global score of 0 at screening and baseline
* Mini Mental State Examination (MMSE) greater than or equal to (>=) 27 (with educational adjustment)
* Able to read and write and with a minimum 5 years of formal education as reported by participant and study partner at screening
* A participant must be of non-childbearing potential
Minimum age
55 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History consistent with or known autosomal dominant AD (mutation identified in the family and/or participant)
* Fulfills diagnostic criteria for Alzheimer's Dementia or non-Alzheimer's Dementia, including, but not limited to Frontotemporal Dementia (FTD), Diffuse Lewy Body Dementia (DLBD), Vascular Dementia (VAD), alcoholic dementia, Parkinson's dementia, Korsakov, Creutzfeldt-Jakob or other prion diseases, Posterior Cortical Atrophy
* Diagnosis of Mild Cognitive Impairment (MCI)
* Vitamin B12 or folate levels below the central laboratory lower limit of normal, unless in the opinion of the investigator it does not require treatment
* History of or current neurological disease other than preclinical AD that may make interpretation of possible new neurological signs or symptoms difficult

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 2
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
22/07/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/05/2033
Actual
Sample size
Target
498
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Neuro Trials Victoria - Carlton
Recruitment hospital [2] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [3] 0 0
St Vincent's Centre for Applied Medical Research - Darlinghurst
Recruitment hospital [4] 0 0
Austin Health Heidelberg Repatriation Hospital - Ivanhoe
Recruitment hospital [5] 0 0
Southern Neurology - Kogarah
Recruitment hospital [6] 0 0
KaRa Institute of Neurological Diseases - Macquarie Park
Recruitment hospital [7] 0 0
Australian Alzheimer's Research Foundation Incorporated - Nedlands
Recruitment postcode(s) [1] 0 0
3053 - Carlton
Recruitment postcode(s) [2] 0 0
4032 - Chermside
Recruitment postcode(s) [3] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [4] 0 0
3079 - Ivanhoe
Recruitment postcode(s) [5] 0 0
2217 - Kogarah
Recruitment postcode(s) [6] 0 0
2113 - Macquarie Park
Recruitment postcode(s) [7] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Mississippi
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
Rhode Island
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Vermont
Country [14] 0 0
United States of America
State/province [14] 0 0
Virginia
Country [15] 0 0
Japan
State/province [15] 0 0
Chofu-shi
Country [16] 0 0
Japan
State/province [16] 0 0
Chuo-ku
Country [17] 0 0
Japan
State/province [17] 0 0
Hirakata-shi
Country [18] 0 0
Japan
State/province [18] 0 0
Kobe City
Country [19] 0 0
Japan
State/province [19] 0 0
Kobe
Country [20] 0 0
Japan
State/province [20] 0 0
Musashimurayama
Country [21] 0 0
Japan
State/province [21] 0 0
Narashino-shi
Country [22] 0 0
Japan
State/province [22] 0 0
Shinjuku-ku
Country [23] 0 0
Japan
State/province [23] 0 0
Shinjyuku Ku
Country [24] 0 0
Japan
State/province [24] 0 0
Suita-shi
Country [25] 0 0
Japan
State/province [25] 0 0
Toyonaka-shi
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Birmingham
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Edinburgh
Country [28] 0 0
United Kingdom
State/province [28] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Pharmaceutica N.V., Belgium
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the effect of JNJ-64042056 on cognitive decline, as measured by Preclinical Alzheimer's disease Cognitive Composite 5 (PACC-5) compared with placebo.
Trial website
https://clinicaltrials.gov/study/NCT06544616
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Pharmaceutica N.V., Belgium Clinical trial
Address 0 0
Janssen Pharmaceutica N.V., Belgium
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06544616