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

Last updated: April 3, 2025
Sponsor: Janssen Pharmaceutica N.V., Belgium
Overall Status: Active - 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 the effect of JNJ-64042056 on cognitive decline, as measured by Preclinical Alzheimer's disease Cognitive Composite 5 (PACC-5) compared with placebo.

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 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 (witheducational adjustment)

  • 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 in the opinion of the investigator it does not require treatment

  • 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: 498
Treatment Group(s): 2
Primary Treatment: JNJ-64042056
Phase: 2
Study Start date:
July 22, 2024
Estimated Completion Date:
May 31, 2033

Connect with a study center

  • Neuro Trials Victoria

    Carlton, 3053
    Australia

    Active - Recruiting

  • The Prince Charles Hospital

    Chermside, 4032
    Australia

    Active - Recruiting

  • St Vincent's Centre for Applied Medical Research

    Darlinghurst, 2010
    Australia

    Active - Recruiting

  • Austin Health Heidelberg Repatriation Hospital

    Ivanhoe, 3079
    Australia

    Active - Recruiting

  • Southern Neurology

    Kogarah, 2217
    Australia

    Active - Recruiting

  • KaRa Institute of Neurological Diseases

    Macquarie Park, 2113
    Australia

    Active - Recruiting

  • Australian Alzheimer's Research Foundation Incorporated

    Nedlands, 6009
    Australia

    Active - Recruiting

  • CHU Toulouse - Hôpital La Grave

    Toulouse, 31059
    France

    Active - Recruiting

  • Enomoto Internal Medicine Clinic

    Chofu-shi, 1820036
    Japan

    Active - Recruiting

  • Tokyo Asbo Clinic

    Chuo-ku, 104-0031
    Japan

    Active - Recruiting

  • Hatsuta Neurology Clinic

    Hirakata-shi, 573-1121
    Japan

    Active - Recruiting

  • Kusunoki Clinic

    Kobe, 650-0044
    Japan

    Active - Recruiting

  • Kobe City Medical Center General Hospital

    Kobe City, 650 0047
    Japan

    Active - Recruiting

  • Musashimurayama Hospital

    Musashimurayama, 208-0022
    Japan

    Active - Recruiting

  • Saiseikai Narashino Hospital

    Narashino-shi, 275-8580
    Japan

    Active - Recruiting

  • ToCROM Clinic

    Shinjuku ku, 160 0008
    Japan

    Active - Recruiting

  • 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

    Active - Recruiting

  • Medical Corporation Heishinkai ToCROM Clinic

    Shinjuku-ku, 160-0008
    Japan

    Active - Recruiting

  • Medical corporation Shinanokai Samoncho Clinic

    Shinjyuku Ku, 160 0017
    Japan

    Active - Recruiting

  • OCROM Clinic

    Suita shi, 565 0853
    Japan

    Active - Recruiting

  • Heishinkai OCROM Clinic

    Suita-shi, 565-0853
    Japan

    Active - Recruiting

  • Heishinkai TOCROM Clinic

    Suita-shi, 565-0853
    Japan

    Site Not Available

  • Medical Corporation Heishinkai OCROM Clinic

    Suita-shi, 565-0853
    Japan

    Active - Recruiting

  • Jinsenkai MI Clinic

    Toyonaka-shi, 560-0004
    Japan

    Active - Recruiting

  • Nagomi Clinic

    Toyonaka-shi, 560-0004
    Japan

    Active - Recruiting

  • Barcelona Beta Brain Research Center

    Barcelona, 08005
    Spain

    Active - Recruiting

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

    Barcelona, 08028
    Spain

    Active - Recruiting

  • Hosp Clinic de Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Centro At. Esp. Oroitu

    Getxo, 48993
    Spain

    Active - Recruiting

  • Hosp. Clinico San Carlos

    Madrid, 28040
    Spain

    Active - Recruiting

  • Clinica Univ. de Navarra

    Pamplona, 31008
    Spain

    Active - Recruiting

  • Hosp. Quiron Madrid Pozuelo

    Pozuelo de Alarcón, 28223
    Spain

    Active - Recruiting

  • Hosp. Mutua Terrassa

    Terrassa, 08222
    Spain

    Active - Recruiting

  • Hosp. Viamed Montecanal

    Zaragoza, 50012
    Spain

    Active - Recruiting

  • Karolinska Universitetssjukhuset Huddinge

    Stockholm, 14186
    Sweden

    Active - Recruiting

  • Karolinska Universitetssjukhuset, Huddinge

    Stockholm, 14186
    Sweden

    Active - Recruiting

  • Royal United Hospital

    Bath, BA1 3NG
    United Kingdom

    Active - Recruiting

  • Re-Cognition Health

    Birmingham, B16 8LT
    United Kingdom

    Active - Recruiting

  • Re-Cognition Health

    Bristol, BS32 4SY
    United Kingdom

    Active - Recruiting

  • Gyleview House

    Edinburgh, EH12 9DQ
    United Kingdom

    Active - Recruiting

  • Scottish Brain Sciences

    Edinburgh, EH12 5PJ
    United Kingdom

    Active - Recruiting

  • Re-Cognition Health

    Guildford, GU2 7YD
    United Kingdom

    Active - Recruiting

  • Cognition Health Ltd

    London, W1G 9JF
    United Kingdom

    Active - Recruiting

  • Kings College Hospital

    London, WC2R 2LS
    United Kingdom

    Active - Recruiting

  • Re-Cognition Health

    London, W1G 8TA
    United Kingdom

    Active - Recruiting

  • University of Oxford

    Oxford, OX3 7JX
    United Kingdom

    Active - Recruiting

  • Re-Cognition Health

    Plymouth, PL6 8BT
    United Kingdom

    Active - Recruiting

  • Moorgreen Hospital Memory Assessment And Research Centre

    Southampton, S03 3JB
    United Kingdom

    Active - Recruiting

  • Southampton General Hospital

    Southampton, SO16 6YD
    United Kingdom

    Active - Recruiting

  • Re-Cognition Health

    Winchester, S021 1HU
    United Kingdom

    Active - Recruiting

  • Xenoscience Inc.

    Phoenix, Arizona 85004
    United States

    Active - Recruiting

  • Irvine Clinical Research

    Irvine, California 92614
    United States

    Active - Recruiting

  • Artemis Institute for Clinical Research

    Riverside, California 92503
    United States

    Active - Recruiting

  • Artemis Institute for Clinical Research

    San Diego, California 92103
    United States

    Active - Recruiting

  • JEM Research LLC

    Atlantis, Florida 33462
    United States

    Active - Recruiting

  • Excel Medical Clinical Trials, LLC

    Boca Raton, Florida 33434
    United States

    Active - Recruiting

  • K2 Medical Research Winter Garden

    Clermont, Florida 34711
    United States

    Active - Recruiting

  • Clinical NeuroScience Solutions Inc

    Jacksonville, Florida 32256
    United States

    Active - Recruiting

  • K2 Medical Research

    Lady Lake, Florida 32159
    United States

    Active - Recruiting

  • K2 Medical Research

    Maitland, Florida 32751
    United States

    Active - Recruiting

  • Merritt Island Medical Research, LLC

    Merritt Island, Florida 32952
    United States

    Active - Recruiting

  • Headlands Research Orlando

    Orlando, Florida 32819
    United States

    Active - Recruiting

  • Alzheimers Research and Treatment Center

    Stuart, Florida 34997
    United States

    Active - Recruiting

  • K2 Medical Research

    Tampa, Florida 33607
    United States

    Active - Recruiting

  • Charter Research

    The Villages, Florida 32162
    United States

    Active - Recruiting

  • K2 Medical Research

    The Villages, Florida 32159
    United States

    Active - Recruiting

  • Alzheimers Research and Treatment Center

    Wellington, Florida 33414
    United States

    Active - Recruiting

  • Palm Beach Neurology and Premier Research Institute

    West Palm Beach, Florida 33407
    United States

    Active - Recruiting

  • Great Lakes Clinical Trials

    Chicago, Illinois 60640
    United States

    Active - Recruiting

  • Great Lakes Clinical Trials

    Gurnee, Illinois 60031
    United States

    Active - Recruiting

  • Quest Research Institute

    Farmington Hills, Michigan 48334
    United States

    Active - Recruiting

  • Hattiesburg Clinic

    Hattiesburg, Mississippi 39401
    United States

    Active - Recruiting

  • The Cognitive and Research Center of New Jersey LLC

    Springfield, New Jersey 07081
    United States

    Active - Recruiting

  • Neurological Associates of Albany, PC

    Albany, New York 12208
    United States

    Active - Recruiting

  • Velocity Clinical Research

    East Syracuse, New York 13057
    United States

    Active - Recruiting

  • The Medical Research Network, LLC

    New York, New York 10128
    United States

    Active - Recruiting

  • AMC Research, LLC

    Matthews, North Carolina 28105
    United States

    Active - Recruiting

  • Valley Medical Research

    Centerville, Ohio 45459-2785
    United States

    Active - Recruiting

  • Keystone Clinical Studies LLC

    Plymouth Meeting, Pennsylvania 19462
    United States

    Active - Recruiting

  • Butler Hospital

    Providence, Rhode Island 02906
    United States

    Active - Recruiting

  • Clinical Trials of Texas Inc

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Memory Clinic Inc

    Bennington, Vermont 05201
    United States

    Active - Recruiting

  • University of Virginia

    Charlottesville, Virginia 22903
    United States

    Active - Recruiting

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