A Study of JNJ-64042056 in Participants With Preclinical Alzheimer's Disease

Last updated: June 4, 2026
Sponsor: Janssen Pharmaceutica N.V., Belgium
Overall Status: Active - Not Recruiting

Phase

2

Condition

N/A

Treatment

JNJ-64042056

Placebo

Clinical Study ID

NCT06544616
64042056ALZ2001
64042056ALZ2001
2023-505096-68-00
  • Ages 55-75
  • All Genders

Study Summary

The purpose of this study is to assess whether JNJ-64042056 affects the spread and build up of tau (a protein in brain) when compared with placebo, using brain scan (tau PET) to determine results from specific areas of the brain.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Elevated brain tau pathology defined as Braak 3 region of interest standardizeduptake value ratio (ROI SUVR) greater than (>) 1.1 (or equivalent based on emergingdata) on a screening tau PET scan, reviewed centrally by a qualified reader toenrich 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 (witheducational adjustment) at screening

  • Able to read and write and with a minimum 5 years of formal education as reported byparticipant and study partner at screening

  • A participant must be of non-childbearing potential

Exclusion

Exclusion Criteria:

  • History consistent with or known autosomal dominant AD (mutation identified in thefamily 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 BodyDementia (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 afterrandomization

  • History of or current neurological disease other than preclinical AD that may makeinterpretation of possible new neurological signs or symptoms difficult

Study Design

Total Participants: 55
Treatment Group(s): 2
Primary Treatment: JNJ-64042056
Phase: 2
Study Start date:
July 22, 2024
Estimated Completion Date:
January 05, 2027

Connect with a study center

  • Neuro Trials Victoria

    Carlton, 3053
    Australia

    Site Not Available

  • The Prince Charles Hospital

    Chermside, 4032
    Australia

    Site Not Available

  • St Vincent's Centre for Applied Medical Research

    Darlinghurst, 2010
    Australia

    Site Not Available

  • Austin Health Heidelberg Repatriation Hospital

    Ivanhoe, 3079
    Australia

    Site Not Available

  • Southern Neurology

    Kogarah, 2217
    Australia

    Site Not Available

  • KaRa Institute of Neurological Diseases

    Macquarie Park, 2113
    Australia

    Site Not Available

  • Alzheimers Research Australia

    Nedlands, 6009
    Australia

    Site Not Available

  • Australian Alzheimer's Research Foundation Incorporated

    Nedlands 2064874, 6009
    Australia

    Active - Recruiting

  • Az Groeninge

    Kortrijk, 8500
    Belgium

    Site Not Available

  • Hopital Roger Salengro - CHU Lille

    Lille, 59037
    France

    Site Not Available

  • Hopital Nord Laennec CHU NANTES

    Nantes, 44800
    France

    Site Not Available

  • CHU Pitie Salpetriere

    Paris, 75013
    France

    Site Not Available

  • Hopital Lariboisiere-Fernand Widal

    Paris, 75010
    France

    Site Not Available

  • CHU Pitie Salpetriere

    Paris 2988507, 75013
    France

    Site Not Available

  • CHU Toulouse - Hôpital La Grave

    Toulouse, 31059
    France

    Site Not Available

  • CHRU Tours Hopital Bretonneau

    Tours, 37000
    France

    Site Not Available

  • Universitaetsklinikum der RWTH Aachen

    Aachen, 52074
    Germany

    Site Not Available

  • Universitaetsklinikum Koeln

    Cologne, 50937
    Germany

    Site Not Available

  • Universitaetsklinikum des Saarlandes

    Homburg, 66421
    Germany

    Site Not Available

  • Universitatsklinikum Munster

    Münster, 48149
    Germany

    Site Not Available

  • Enomoto Internal Medicine Clinic

    Chofu-shi, 1820036
    Japan

    Site Not Available

  • Tokyo Asbo Clinic

    Chūōku, 104-0031
    Japan

    Site Not Available

  • Hatsuta Neurology Clinic

    Hirakata-shi, 573-1121
    Japan

    Site Not Available

  • Kobe City Medical Center General Hospital

    Kobe, 650 0047
    Japan

    Site Not Available

  • Kusunoki Clinic

    Kobe, 650-0044
    Japan

    Site Not Available

  • Kobe City Medical Center General Hospital

    Kobe 1859171, 650 0047
    Japan

    Site Not Available

  • Musashimurayama Hospital

    Musashimurayama, 208-0022
    Japan

    Site Not Available

  • Saiseikai Narashino Hospital

    Narashino-shi, 275-8580
    Japan

    Site Not Available

  • ToCROM Clinic

    Shinjuku Ku, 160 0008
    Japan

    Site Not Available

  • Heishinkai OCROM Clinic

    Shinjuku-ku, 160-0008
    Japan

    Active - Recruiting

  • Heishinkai TOCROM Clinic

    Shinjuku-ku, 160-0008
    Japan

    Active - Recruiting

  • Higashi-Shinjuku Clinic

    Shinjuku-ku, 169-0072
    Japan

    Site Not Available

  • Medical Corporation Heishinkai ToCROM Clinic

    Shinjuku-ku, 160-0008
    Japan

    Active - Recruiting

  • Medical corporation Shinanokai Samoncho Clinic

    Shinjyuku Ku, 160 0017
    Japan

    Site Not Available

  • OCROM Clinic

    Suita Shi, 565 0853
    Japan

    Site Not Available

  • Heishinkai OCROM Clinic

    Suita-shi, 565-0853
    Japan

    Active - Recruiting

  • Medical Corporation Heishinkai OCROM Clinic

    Suita-shi, 565-0853
    Japan

    Active - Recruiting

  • Jinsenkai MI Clinic

    Toyonaka-shi, 5600004
    Japan

    Site Not Available

  • Nagomi Clinic

    Toyonaka-shi, 560-0004
    Japan

    Site Not Available

  • Barcelona Beta Brain Research Center

    Barcelona, 08005
    Spain

    Site Not Available

  • Fund. Ace-Inst. Cat. Neuroc. Aplicades

    Barcelona, 08028
    Spain

    Site Not Available

  • Hosp Clinic de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Barcelona Beta Brain Research Center

    Barcelona 3128760, 08005
    Spain

    Site Not Available

  • Hosp Clinic de Barcelona

    Barcelona 3128760, 08036
    Spain

    Site Not Available

  • Centro At. Esp. Oroitu

    Getxo, 48993
    Spain

    Site Not Available

  • Hosp. Univ. Santa Maria

    Lleida, 25198
    Spain

    Site Not Available

  • Hosp. Clinico San Carlos

    Madrid, 28040
    Spain

    Site Not Available

  • Clinica Univ. de Navarra

    Pamplona, 31008
    Spain

    Site Not Available

  • Hosp. Quiron Madrid Pozuelo

    Pozuelo de Alarcón, 28223
    Spain

    Site Not Available

  • Idc Salud Hosp. Gral. de Catalunya

    Sant Cugat del Vallès, 08190
    Spain

    Site Not Available

  • Hosp. Mutua Terrassa

    Terrassa, 08222
    Spain

    Site Not Available

  • Hosp. Viamed Montecanal

    Zaragoza, 50012
    Spain

    Site Not Available

  • Skanes universitetssjukhus

    Malmö, 20502
    Sweden

    Site Not Available

  • Karolinska Universitetssjukhuset Huddinge

    Stockholm, 14186
    Sweden

    Site Not Available

  • Karolinska Universitetssjukhuset, Huddinge

    Stockholm, 14186
    Sweden

    Active - Recruiting

  • Royal United Hospital

    Bath, BA1 3NG
    United Kingdom

    Site Not Available

  • Re-Cognition Health Birmingham

    Birmingham, B16 8LT
    United Kingdom

    Site Not Available

  • Re-Cognition Health Bristol

    Bristol, BS32 4SY
    United Kingdom

    Site Not Available

  • Gyleview House

    Edinburgh, EH12 9DQ
    United Kingdom

    Active - Recruiting

  • Scottish Brain Sciences

    Edinburgh, EH12 5PJ
    United Kingdom

    Site Not Available

  • Re-Cognition Health Guildford

    Guildford, GU2 7YD
    United Kingdom

    Site Not Available

  • Cognition Health Ltd

    London, W1G 9JF
    United Kingdom

    Active - Recruiting

  • Kings College Hospital

    London, WC2R 2LS
    United Kingdom

    Site Not Available

  • Re-Cognition Health

    London, W1G 8TA
    United Kingdom

    Active - Recruiting

  • Re-Cognition Health London

    London, W1G 8TA
    United Kingdom

    Site Not Available

  • Kings College Hospital

    London 2643743, WC2R 2LS
    United Kingdom

    Site Not Available

  • University of Oxford

    Oxford, OX3 7JX
    United Kingdom

    Site Not Available

  • Re-Cognition Health Plymouth

    Plymouth, PL6 8BT
    United Kingdom

    Site Not Available

  • Moorgreen Hospital Memory Assessment And Research Centre

    Southampton, S03 3JB
    United Kingdom

    Site Not Available

  • Southampton General Hospital

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

  • Southampton General Hospital

    Southampton 2637487, SO16 6YD
    United Kingdom

    Site Not Available

  • Re-Cognition Health Winchester

    Winchester, SO23 8SR
    United Kingdom

    Site Not Available

  • Xenoscience Inc.

    Phoenix, Arizona 85004
    United States

    Site Not Available

  • Irvine Clinical Research

    Irvine, California 92614
    United States

    Site Not Available

  • Esperanza Clinical

    Murrieta, California 92562
    United States

    Site Not Available

  • Artemis Institute for Clinical Research Riverside

    Riverside, California 92503
    United States

    Site Not Available

  • Artemis Institute for Clinical Research San Diego

    San Diego, California 92123
    United States

    Site Not Available

  • Artemis Institute for Clinical Research

    San Diego 5391811, California 5332921 92103
    United States

    Active - Recruiting

  • Yale University School Of Medicine

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • JEM Research LLC

    Atlantis, Florida 33462
    United States

    Site Not Available

  • Excel Medical Clinical Trials, LLC

    Boca Raton, Florida 33434
    United States

    Site Not Available

  • K2 Medical Research Winter Garden

    Clermont, Florida 34711
    United States

    Site Not Available

  • Clinical NeuroScience Solutions Inc

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • K2 Medical Research Lady Lake

    Lady Lake, Florida 32159
    United States

    Site Not Available

  • K2 Medical Research Maitland

    Maitland, Florida 32751
    United States

    Site Not Available

  • Merritt Island Medical Research, LLC

    Merritt Island, Florida 32952
    United States

    Site Not Available

  • Headlands Research Orlando

    Orlando, Florida 32806
    United States

    Site Not Available

  • Alzheimers Research and Treatment Center Stuart

    Stuart, Florida 34997
    United States

    Site Not Available

  • K2 Medical Research Tampa

    Tampa, Florida 33634
    United States

    Site Not Available

  • Charter Research

    The Villages, Florida 32162
    United States

    Site Not Available

  • K2 Medical Research

    The Villages, Florida 32159
    United States

    Active - Recruiting

  • Alzheimers Research and Treatment Center Wellington

    Wellington, Florida 33414
    United States

    Site Not Available

  • Palm Beach Neurology and Premier Research Institute

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • Headlands Research Orlando

    Orlando 4167147, Florida 4155751 32819
    United States

    Active - Recruiting

  • K2 Medical Research

    Tampa 4174757, Florida 4155751 33607
    United States

    Active - Recruiting

  • Great Lakes Clinical Trials Chicago

    Chicago, Illinois 60640
    United States

    Site Not Available

  • Great Lakes Clinical Trials Gurnee

    Gurnee, Illinois 60031
    United States

    Site Not Available

  • Quest Research Institute

    Farmington Hills, Michigan 48334
    United States

    Site Not Available

  • Hattiesburg Clinic

    Hattiesburg, Mississippi 39401
    United States

    Site Not Available

  • The Cognitive and Research Center of New Jersey LLC

    Springfield, New Jersey 07081
    United States

    Site Not Available

  • Neurological Associates of Albany, PC

    Albany, New York 12208
    United States

    Site Not Available

  • Velocity Clinical Research East Syracuse

    East Syracuse, New York 13057
    United States

    Site Not Available

  • The Medical Research Network, LLC

    New York, New York 10128
    United States

    Site Not Available

  • AMC Research, LLC

    Matthews, North Carolina 28105
    United States

    Site Not Available

  • Valley Medical Research

    Centerville, Ohio 45459-2785
    United States

    Site Not Available

  • Keystone Clinical Studies LLC

    Plymouth Meeting, Pennsylvania 19462
    United States

    Site Not Available

  • Butler Hospital

    Providence, Rhode Island 02906
    United States

    Site Not Available

  • Clinical Trials of Texas Inc

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Memory Clinic Inc

    Bennington, Vermont 05201
    United States

    Site Not Available

  • University of Virginia

    Charlottesville, Virginia 22903
    United States

    Site Not Available

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