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ACTIVE NOT RECRUITING
NCT06544616
PHASE2

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

Sponsor: Janssen Pharmaceutica N.V., Belgium

View on ClinicalTrials.gov

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.

Official 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

Key Details

Gender

All

Age Range

55 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

498

Start Date

2024-07-22

Completion Date

2032-07-16

Last Updated

2026-02-17

Healthy Volunteers

No

Interventions

DRUG

JNJ-64042056

JNJ-64042056 will be administered intramuscularly.

DRUG

Placebo

Placebo will be administered intramuscularly.

Locations (90)

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

Alzheimers Research Australia

Nedlands, Australia

Az Groeninge

Kortrijk, Belgium

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