A Study of JNJ-64042056 in Participants With Preclinical Alzheimer's Disease
NCT ID: NCT06544616
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
498 participants
INTERVENTIONAL
2024-07-22
2034-06-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm A: JNJ-64042056
Participants will receive intramuscular (IM) injection of JNJ-64042056 from Week 0 until Week 180.
JNJ-64042056
JNJ-64042056 will be administered intramuscularly.
Arm B: Placebo
Participants will receive IM injection of placebo from Week 0 until Week 180.
Placebo
Placebo will be administered intramuscularly.
Interventions
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JNJ-64042056
JNJ-64042056 will be administered intramuscularly.
Placebo
Placebo will be administered intramuscularly.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
55 Years
75 Years
ALL
No
Sponsors
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Janssen Pharmaceutica N.V., Belgium
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Pharmaceutica N.V., Belgium Clinical trial
Role: STUDY_DIRECTOR
Janssen Pharmaceutica N.V., Belgium
Locations
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Xenoscience Inc.
Phoenix, Arizona, United States
Irvine Clinical Research
Irvine, California, United States
Esperanza Clinical
Murrieta, California, United States
Artemis Institute for Clinical Research
Riverside, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
Yale University School Of Medicine
New Haven, Connecticut, United States
JEM Research LLC
Atlantis, Florida, United States
Excel Medical Clinical Trials, LLC
Boca Raton, Florida, United States
K2 Medical Research Winter Garden
Clermont, Florida, United States
Clinical NeuroScience Solutions Inc
Jacksonville, Florida, United States
K2 Medical Research
Lady Lake, Florida, United States
K2 Medical Research
Maitland, Florida, United States
Merritt Island Medical Research, LLC
Merritt Island, Florida, United States
Headlands Research Orlando
Orlando, Florida, United States
Alzheimers Research and Treatment Center
Stuart, Florida, United States
K2 Medical Research
Tampa, Florida, United States
Charter Research
The Villages, Florida, United States
Alzheimers Research and Treatment Center
Wellington, Florida, United States
Palm Beach Neurology and Premier Research Institute
West Palm Beach, Florida, United States
Great Lakes Clinical Trials
Chicago, Illinois, United States
Great Lakes Clinical Trials
Gurnee, Illinois, United States
Quest Research Institute
Farmington Hills, Michigan, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, United States
The Cognitive and Research Center of New Jersey LLC
Springfield, New Jersey, United States
Neurological Associates of Albany, PC
Albany, New York, United States
Velocity Clinical Research
East Syracuse, New York, United States
The Medical Research Network, LLC
New York, New York, United States
AMC Research, LLC
Matthews, North Carolina, United States
Valley Medical Research
Centerville, Ohio, United States
Keystone Clinical Studies LLC
Plymouth Meeting, Pennsylvania, United States
Butler Hospital
Providence, Rhode Island, United States
Clinical Trials of Texas Inc
San Antonio, Texas, United States
Memory Clinic Inc
Bennington, Vermont, United States
University of Virginia
Charlottesville, Virginia, United States
Neuro Trials Victoria
Carlton, , Australia
The Prince Charles Hospital
Chermside, , Australia
St Vincent's Centre for Applied Medical Research
Darlinghurst, , Australia
Austin Health Heidelberg Repatriation Hospital
Ivanhoe, , Australia
Southern Neurology
Kogarah, , Australia
KaRa Institute of Neurological Diseases
Macquarie Park, , Australia
Australian Alzheimer's Research Foundation Incorporated
Nedlands, , Australia
Hopital Roger Salengro - CHU Lille
Lille, , France
Hopital Nord Laennec CHU NANTES
Nantes, , France
Hopital Lariboisiere-Fernand Widal
Paris, , France
CHU Pitie Salpetriere
Paris, , France
CHU Toulouse - Hôpital La Grave
Toulouse, , France
CHRU Tours Hopital Bretonneau
Tours, , France
Universitaetsklinikum der RWTH Aachen
Aachen, , Germany
Universitaetsklinikum Koeln
Cologne, , Germany
Universitaetsklinikum des Saarlandes
Homburg, , Germany
Universitatsklinikum Munster
Münster, , Germany
Enomoto Internal Medicine Clinic
Chofu-shi, , Japan
Tokyo Asbo Clinic
Chūōku, , Japan
Hatsuta Neurology Clinic
Hirakata-shi, , Japan
Kobe City Medical Center General Hospital
Kobe, , Japan
Kusunoki Clinic
Kobe, , Japan
Musashimurayama Hospital
Musashimurayama, , Japan
Saiseikai Narashino Hospital
Narashino-shi, , Japan
ToCROM Clinic
Shinjuku Ku, , Japan
Higashi-Shinjuku Clinic
Shinjuku-ku, , Japan
Medical corporation Shinanokai Samoncho Clinic
Shinjyuku Ku, , Japan
OCROM Clinic
Suita Shi, , Japan
Nagomi Clinic
Toyonaka-shi, , Japan
Jinsenkai MI Clinic
Toyonaka-shi, , Japan
Barcelona Beta Brain Research Center
Barcelona, , Spain
Fund. Ace-Inst. Cat. Neuroc. Aplicades
Barcelona, , Spain
Hosp Clinic de Barcelona
Barcelona, , Spain
Centro At. Esp. Oroitu
Getxo, , Spain
Hosp. Univ. Santa Maria
Lleida, , Spain
Hosp. Clinico San Carlos
Madrid, , Spain
Clinica Univ. de Navarra
Pamplona, , Spain
Hosp. Quiron Madrid Pozuelo
Pozuelo de Alarcón, , Spain
Idc Salud Hosp. Gral. de Catalunya
Sant Cugat del Vallès, , Spain
Hosp. Mutua Terrassa
Terrassa, , Spain
Hosp. Viamed Montecanal
Zaragoza, , Spain
Skanes universitetssjukhus
Malmo, , Sweden
Karolinska Universitetssjukhuset Huddinge
Stockholm, , Sweden
Royal United Hospital
Bath, , United Kingdom
Re-Cognition Health
Birmingham, , United Kingdom
Re-Cognition Health
Bristol, , United Kingdom
Scottish Brain Sciences
Edinburgh, , United Kingdom
Re-Cognition Health
Guildford, , United Kingdom
Re-Cognition Health
London, , United Kingdom
Kings College Hospital
London, , United Kingdom
University of Oxford
Oxford, , United Kingdom
Re-Cognition Health
Plymouth, , United Kingdom
Moorgreen Hospital Memory Assessment And Research Centre
Southampton, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Re-Cognition Health
Winchester, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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64042056ALZ2001
Identifier Type: OTHER
Identifier Source: secondary_id
2023-505096-68-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
64042056ALZ2001
Identifier Type: -
Identifier Source: org_study_id