A Study of JNJ-64042056 in Participants With Preclinical Alzheimer's Disease
Reτain
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
2 other identifiers
interventional
498
9 countries
90
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2024
Longer than P75 for phase_2
90 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 22, 2024
CompletedFirst Submitted
Initial submission to the registry
August 6, 2024
CompletedFirst Posted
Study publicly available on registry
August 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 17, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 16, 2032
February 17, 2026
February 1, 2026
7 years
August 6, 2024
February 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Preclinical Alzheimer's Disease Cognitive Composite 5 (PACC-5) Total Scores up to Week 206
Cognition will be measured using the PACC-5 scale, which includes 5 components: free/cued selective reminding test, delayed paragraph recall (logical memory test), digit-symbol substitution test, mini mental state examination, and the category fluency test (CFT). PACC-5 is a composite score which provides unique information about early cognitive decline not currently captured by the episodic memory, executive function, and global cognition components. The total score is a sum of z-score, with higher scores indicating better cognitive performance.
Baseline up to Week 206
Secondary Outcomes (21)
Change From Baseline in Brain tau Burden as Measured by tau PET
Baseline and Weeks 102, 154 and 206
Change From Baseline in PACC-5 Individual Domain Scores
Baseline up to Week 206
Time to Event of Clinical Progression as Measured by Clinical Dementia Rating-Global Score (CDR-GS)
Baseline up to Week 206
Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Scores
Baseline up to Week 206
Change from Baseline in Tau PET Standardized Uptake Value Ratio (SUVR) Biomarkers
Baseline up to Week 206
- +16 more secondary outcomes
Study Arms (2)
Arm A: JNJ-64042056
EXPERIMENTALParticipants will receive intramuscular (IM) injection of JNJ-64042056 from Week 0 until Week 180.
Arm B: Placebo
PLACEBO COMPARATORParticipants will receive IM injection of placebo from Week 0 until Week 180.
Interventions
Eligibility Criteria
You may qualify if:
- Elevated brain tau pathology defined as Braak 3 region of interest standardized uptake value ratio (ROI SUVR) greater than (\>) 1.1 (or equivalent based on emerging data) on a screening tau PET scan, reviewed centrally by a qualified reader to enrich for probability of disease progression during the study
- 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) at screening
- 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
You may not qualify if:
- 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 the investigator determines that supplementation is not required after randomization
- History of or current neurological disease other than preclinical AD that may make interpretation of possible new neurological signs or symptoms difficult
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (90)
Xenoscience Inc.
Phoenix, Arizona, 85004, United States
Irvine Clinical Research
Irvine, California, 92614, United States
Esperanza Clinical
Murrieta, California, 92562, United States
Artemis Institute for Clinical Research
Riverside, California, 92503, United States
Artemis Institute for Clinical Research
San Diego, California, 92123, United States
Yale University School Of Medicine
New Haven, Connecticut, 06510, United States
JEM Research LLC
Atlantis, Florida, 33462, United States
Excel Medical Clinical Trials, LLC
Boca Raton, Florida, 33434, United States
K2 Medical Research Winter Garden
Clermont, Florida, 34711, United States
Clinical NeuroScience Solutions Inc
Jacksonville, Florida, 32256, United States
K2 Medical Research
Lady Lake, Florida, 32159, United States
K2 Medical Research
Maitland, Florida, 32751, United States
Merritt Island Medical Research, LLC
Merritt Island, Florida, 32952, United States
Headlands Research Orlando
Orlando, Florida, 32806, United States
Alzheimers Research and Treatment Center
Stuart, Florida, 34997, United States
K2 Medical Research
Tampa, Florida, 33634, United States
Charter Research
The Villages, Florida, 32162, United States
Alzheimers Research and Treatment Center
Wellington, Florida, 33414, United States
Palm Beach Neurology and Premier Research Institute
West Palm Beach, Florida, 33407, United States
Great Lakes Clinical Trials
Chicago, Illinois, 60640, United States
Great Lakes Clinical Trials
Gurnee, Illinois, 60031, United States
Quest Research Institute
Farmington Hills, Michigan, 48334, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, 39401, United States
The Cognitive and Research Center of New Jersey LLC
Springfield, New Jersey, 07081, United States
Neurological Associates of Albany, PC
Albany, New York, 12208, United States
Velocity Clinical Research
East Syracuse, New York, 13057, United States
The Medical Research Network, LLC
New York, New York, 10128, United States
AMC Research, LLC
Matthews, North Carolina, 28105, United States
Valley Medical Research
Centerville, Ohio, 45459-2785, United States
Keystone Clinical Studies LLC
Plymouth Meeting, Pennsylvania, 19462, United States
Butler Hospital
Providence, Rhode Island, 02906, United States
Clinical Trials of Texas Inc
San Antonio, Texas, 78229, United States
Memory Clinic Inc
Bennington, Vermont, 05201, United States
University of Virginia
Charlottesville, Virginia, 22903, United States
Neuro Trials Victoria
Carlton, 3053, Australia
The Prince Charles Hospital
Chermside, 4032, Australia
St Vincent's Centre for Applied Medical Research
Darlinghurst, 2010, Australia
Austin Health Heidelberg Repatriation Hospital
Ivanhoe, 3079, Australia
Southern Neurology
Kogarah, 2217, Australia
KaRa Institute of Neurological Diseases
Macquarie Park, 2113, Australia
Alzheimers Research Australia
Nedlands, 6009, Australia
Az Groeninge
Kortrijk, 8500, Belgium
Hopital Roger Salengro - CHU Lille
Lille, 59037, France
Hopital Nord Laennec CHU NANTES
Nantes, 44800, France
Hopital Lariboisiere-Fernand Widal
Paris, 75010, France
CHU Pitie Salpetriere
Paris, 75013, France
CHU Toulouse - Hôpital La Grave
Toulouse, 31059, France
CHRU Tours Hopital Bretonneau
Tours, 37000, France
Universitaetsklinikum der RWTH Aachen
Aachen, 52074, Germany
Universitaetsklinikum Koeln
Cologne, 50937, Germany
Universitaetsklinikum des Saarlandes
Homburg, 66421, Germany
Universitatsklinikum Munster
Münster, 48149, Germany
Enomoto Internal Medicine Clinic
Chofu-shi, 1820036, Japan
Tokyo Asbo Clinic
Chūōku, 104-0031, Japan
Hatsuta Neurology Clinic
Hirakata-shi, 573-1121, Japan
Kobe City Medical Center General Hospital
Kobe, 650 0047, Japan
Kusunoki Clinic
Kobe, 650-0044, Japan
Musashimurayama Hospital
Musashimurayama, 208-0022, Japan
Saiseikai Narashino Hospital
Narashino-shi, 275-8580, Japan
ToCROM Clinic
Shinjuku Ku, 160 0008, Japan
Higashi-Shinjuku Clinic
Shinjuku-ku, 169-0072, Japan
Medical corporation Shinanokai Samoncho Clinic
Shinjyuku Ku, 160 0017, Japan
OCROM Clinic
Suita Shi, 565 0853, Japan
Nagomi Clinic
Toyonaka-shi, 560-0004, Japan
Jinsenkai MI Clinic
Toyonaka-shi, 5600004, Japan
Barcelona Beta Brain Research Center
Barcelona, 08005, Spain
Fund. Ace-Inst. Cat. Neuroc. Aplicades
Barcelona, 08028, Spain
Hosp Clinic de Barcelona
Barcelona, 08036, Spain
Centro At. Esp. Oroitu
Getxo, 48993, Spain
Hosp. Univ. Santa Maria
Lleida, 25198, Spain
Hosp. Clinico San Carlos
Madrid, 28040, Spain
Clinica Univ. de Navarra
Pamplona, 31008, Spain
Hosp. Quiron Madrid Pozuelo
Pozuelo de Alarcón, 28223, Spain
Idc Salud Hosp. Gral. de Catalunya
Sant Cugat del Vallès, 08190, Spain
Hosp. Mutua Terrassa
Terrassa, 08222, Spain
Hosp. Viamed Montecanal
Zaragoza, 50012, Spain
Skanes universitetssjukhus
Malmo, 20502, Sweden
Karolinska Universitetssjukhuset Huddinge
Stockholm, 14186, Sweden
Royal United Hospital
Bath, BA1 3NG, United Kingdom
Re-Cognition Health
Birmingham, B16 8LT, United Kingdom
Re-Cognition Health
Bristol, BS32 4SY, United Kingdom
Scottish Brain Sciences
Edinburgh, EH12 5PJ, United Kingdom
Re-Cognition Health
Guildford, GU2 7YD, United Kingdom
Re-Cognition Health
London, W1G 8TA, United Kingdom
Kings College Hospital
London, WC2R 2LS, United Kingdom
University of Oxford
Oxford, OX3 7JX, United Kingdom
Re-Cognition Health
Plymouth, PL6 8BT, United Kingdom
Moorgreen Hospital Memory Assessment And Research Centre
Southampton, S03 3JB, United Kingdom
Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
Re-Cognition Health
Winchester, SO23 8SR, United Kingdom
Study Officials
- STUDY DIRECTOR
Janssen Pharmaceutica N.V., Belgium Clinical trial
Janssen Pharmaceutica N.V., Belgium
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2024
First Posted
August 9, 2024
Study Start
July 22, 2024
Primary Completion (Estimated)
July 17, 2031
Study Completion (Estimated)
July 16, 2032
Last Updated
February 17, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.