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NCT06544616Active, not recruitingPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
55 (actual)
First submitted
6 Aug 2024
Start date
22 Jul 2024
Primary completion date
22 Dec 2026
Lead sponsor
Janssen Pharmaceutica N.V., Belgium
NCT number
NCT06544616
EU CT number
2023-505096-68-00

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 55
  • From 22 Jul 2024 to the primary completion date, 22 Dec 2026
  • 90 sites in 9 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

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

Lab values

  • Vitamin B12 or folate levels below the central laboratory lower limit of normal, unless the investigator determines that supplementation is not required after randomization

Other

  • History consistent with or known autosomal dominant AD (mutation identified in the family and/or participant)

Who the study is looking for

  • 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

Age in the registry: 55 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (90)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Neuro Trials Victoria
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CarltonAustraliaUnknown status
The Prince Charles Hospital
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ChermsideAustraliaUnknown status
St Vincent's Centre for Applied Medical Research
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DarlinghurstAustraliaUnknown status
Austin Health - Heidelberg Repatriation Hospital
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IvanhoeAustraliaUnknown status
Southern Neurology
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KogarahAustraliaUnknown status
KaRa Institute of Neurological Diseases
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Macquarie ParkAustraliaUnknown status
Alzheimers Research Australia
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NedlandsAustraliaUnknown status
AZ Groeninge
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KortrijkBelgiumUnknown status
Universitaetsklinikum der RWTH Aachen
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AachenGermanyUnknown status
Universitaetsklinikum Koeln
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CologneGermanyUnknown status
Universitaetsklinikum des Saarlandes
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HomburgGermanyUnknown status
Universitätsklinikum Münster
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MünsterGermanyUnknown status
Fund. Ace-Inst. Cat. Neuroc. Aplicades
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BarcelonaSpainUnknown status
Hosp Clinic de Barcelona
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BarcelonaSpainUnknown status
Barcelona Beta Brain Research Center
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BarcelonaSpainUnknown status
Centro At. Esp. Oroitu
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GetxoSpainUnknown status
Hosp. Univ. Santa Maria
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LleidaSpainUnknown status
Hosp. Clinico San Carlos
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MadridSpainUnknown status
Clinica Univ. de Navarra
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PamplonaSpainUnknown status
Hosp. Quiron Madrid Pozuelo
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Pozuelo de AlarcónSpainUnknown status
Idc Salud Hosp. Gral. de Catalunya
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Sant Cugat del VallèsSpainUnknown status
Hosp. Mutua Terrassa
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TerrassaSpainUnknown status
Hosp. Viamed Montecanal
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ZaragozaSpainUnknown status
Hopital Roger Salengro, CHU Lille
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LilleFranceUnknown status
Hopital Nord Laennec CHU NANTES
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NantesFranceUnknown status
CHU Pitie Salpetriere
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ParisFranceUnknown status
Hopital Lariboisiere-Fernand Widal
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ParisFranceUnknown status
CHU Toulouse - Hôpital La Grave
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ToulouseFranceUnknown status
CHRU Tours Hopital Bretonneau
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ToursFranceUnknown status
Royal United Hospital
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BathUnited KingdomUnknown status
Re:Cognition Health - Birmingham
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BirminghamUnited KingdomUnknown status
Re:Cognition Health - Bristol
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BristolUnited KingdomUnknown status
Scottish Brain Sciences
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EdinburghUnited KingdomUnknown status
Re:Cognition Health - Guildford
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GuildfordUnited KingdomUnknown status
Kings College Hospital
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LondonUnited KingdomUnknown status
Re:Cognition Health - London
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LondonUnited KingdomUnknown status
University of Oxford
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OxfordUnited KingdomUnknown status
Re:Cognition Health - Plymouth
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PlymouthUnited KingdomUnknown status
Moorgreen Hospital Memory Assessment And Research Centre
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SouthamptonUnited KingdomUnknown status
Southampton General Hospital
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SouthamptonUnited KingdomUnknown status
Re:Cognition Health - Winchester
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WinchesterUnited KingdomUnknown status
Enomoto Internal Medicine Clinic
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Chofu-shiJapanUnknown status
Tokyo Asbo Clinic
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ChūōkuJapanUnknown status
Hatsuta Neurology Clinic
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Hirakata-shiJapanUnknown status
Kusunoki Clinic
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KobeJapanUnknown status
Kobe City Medical Center General Hospital
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KobeJapanUnknown status
Musashimurayama Hospital
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MusashimurayamaJapanUnknown status
Saiseikai Narashino Hospital
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Narashino-shiJapanUnknown status
Higashi Shinjuku Clinic
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Shinjuku-kuJapanUnknown status
ToCROM Clinic
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Shinjuku KuJapanUnknown status
Medical corporation Shinanokai Samoncho Clinic
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Shinjyuku KuJapanUnknown status
OCROM Clinic
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Suita ShiJapanUnknown status
Jinsenkai MI Clinic
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Toyonaka-shiJapanUnknown status
Nagomi Clinic
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Toyonaka-shiJapanUnknown status
Skånes universitetssjukhus
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MalmöSwedenUnknown status
Karolinska universitetssjukhuset - Huddinge
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StockholmSwedenUnknown status
Neurological Associates of Albany, PC
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AlbanyUnited StatesUnknown status
JEM Research LLC
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AtlantisUnited StatesUnknown status
Memory Clinic, Inc.
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BenningtonUnited StatesUnknown status
Excel Medical Clinical Trials, LLC
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Boca RatonUnited StatesUnknown status
Valley Medical Research
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CentervilleUnited StatesUnknown status
University of Virginia
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CharlottesvilleUnited StatesUnknown status
Great Lakes Clinical Trials Chicago
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ChicagoUnited StatesUnknown status
K2 Medical Research WINTER GARDEN
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ClermontUnited StatesUnknown status
Velocity Clinical Research East Syracuse
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East SyracuseUnited StatesUnknown status
QUEST Research Institute
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Farmington HillsUnited StatesUnknown status
Great Lakes Clinical Trials - Gurnee
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GurneeUnited StatesUnknown status
Hattiesburg Clinic
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HattiesburgUnited StatesUnknown status
Irvine Clinical Research
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IrvineUnited StatesUnknown status
Clinical NeuroScience Solutions Inc
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JacksonvilleUnited StatesUnknown status
K2 Medical Research Lady Lake
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Lady LakeUnited StatesUnknown status
K2 Medical Research - Maitland
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MaitlandUnited StatesUnknown status
AMC Research, LLC
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MatthewsUnited StatesUnknown status
Merritt Island Medical Research, LLC
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Merritt IslandUnited StatesUnknown status
Esperanza Clinical
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MurrietaUnited StatesUnknown status
Yale University School Of Medicine
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New HavenUnited StatesUnknown status
The Medical Research Network, LLC
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New YorkUnited StatesUnknown status
Headlands Research Orlando
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OrlandoUnited StatesUnknown status
Xenoscience Inc.
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PhoenixUnited StatesUnknown status
Keystone Clinical Studies, LLC
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Plymouth MeetingUnited StatesUnknown status
Butler Hospital
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ProvidenceUnited StatesUnknown status
Artemis Institute for Clinical Research Riverside
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RiversideUnited StatesUnknown status
Clinical Trials of Texas Inc
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San AntonioUnited StatesUnknown status
Artemis Institute for Clinical Research San Diego
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San DiegoUnited StatesUnknown status
The Cognitive and Research Center of New Jersey LLC
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SpringfieldUnited StatesUnknown status
Alzheimers Research and Treatment Center Stuart
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StuartUnited StatesUnknown status
K2 Medical Research - Tampa
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TampaUnited StatesUnknown status
Charter Research
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The VillagesUnited StatesUnknown status
Alzheimers Research and Treatment Center - Wellington
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WellingtonUnited StatesUnknown status
Palm Beach Neurology and Premier Research Institute
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West Palm BeachUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.