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
- Diseases
- Alzheimer disease
- 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
Sites (90)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Neuro Trials Victoria Coordinator of this site? Confirm its status | Carlton | Australia | Unknown status |
| The Prince Charles Hospital Coordinator of this site? Confirm its status | Chermside | Australia | Unknown status |
| St Vincent's Centre for Applied Medical Research Coordinator of this site? Confirm its status | Darlinghurst | Australia | Unknown status |
| Austin Health - Heidelberg Repatriation Hospital Coordinator of this site? Confirm its status | Ivanhoe | Australia | Unknown status |
| Southern Neurology Coordinator of this site? Confirm its status | Kogarah | Australia | Unknown status |
| KaRa Institute of Neurological Diseases Coordinator of this site? Confirm its status | Macquarie Park | Australia | Unknown status |
| Alzheimers Research Australia Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| AZ Groeninge Coordinator of this site? Confirm its status | Kortrijk | Belgium | Unknown status |
| Universitaetsklinikum der RWTH Aachen Coordinator of this site? Confirm its status | Aachen | Germany | Unknown status |
| Universitaetsklinikum Koeln Coordinator of this site? Confirm its status | Cologne | Germany | Unknown status |
| Universitaetsklinikum des Saarlandes Coordinator of this site? Confirm its status | Homburg | Germany | Unknown status |
| Universitätsklinikum Münster Coordinator of this site? Confirm its status | Münster | Germany | Unknown status |
| Fund. Ace-Inst. Cat. Neuroc. Aplicades Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hosp Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Barcelona Beta Brain Research Center Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Centro At. Esp. Oroitu Coordinator of this site? Confirm its status | Getxo | Spain | Unknown status |
| Hosp. Univ. Santa Maria Coordinator of this site? Confirm its status | Lleida | Spain | Unknown status |
| Hosp. Clinico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Clinica Univ. de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Unknown status |
| Hosp. Quiron Madrid Pozuelo Coordinator of this site? Confirm its status | Pozuelo de Alarcón | Spain | Unknown status |
| Idc Salud Hosp. Gral. de Catalunya Coordinator of this site? Confirm its status | Sant Cugat del Vallès | Spain | Unknown status |
| Hosp. Mutua Terrassa Coordinator of this site? Confirm its status | Terrassa | Spain | Unknown status |
| Hosp. Viamed Montecanal Coordinator of this site? Confirm its status | Zaragoza | Spain | Unknown status |
| Hopital Roger Salengro, CHU Lille Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Hopital Nord Laennec CHU NANTES Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| CHU Pitie Salpetriere Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hopital Lariboisiere-Fernand Widal Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| CHU Toulouse - Hôpital La Grave Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| CHRU Tours Hopital Bretonneau Coordinator of this site? Confirm its status | Tours | France | Unknown status |
| Royal United Hospital Coordinator of this site? Confirm its status | Bath | United Kingdom | Unknown status |
| Re:Cognition Health - Birmingham Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| Re:Cognition Health - Bristol Coordinator of this site? Confirm its status | Bristol | United Kingdom | Unknown status |
| Scottish Brain Sciences Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Unknown status |
| Re:Cognition Health - Guildford Coordinator of this site? Confirm its status | Guildford | United Kingdom | Unknown status |
| Kings College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Re:Cognition Health - London Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| University of Oxford Coordinator of this site? Confirm its status | Oxford | United Kingdom | Unknown status |
| Re:Cognition Health - Plymouth Coordinator of this site? Confirm its status | Plymouth | United Kingdom | Unknown status |
| Moorgreen Hospital Memory Assessment And Research Centre Coordinator of this site? Confirm its status | Southampton | United Kingdom | Unknown status |
| Southampton General Hospital Coordinator of this site? Confirm its status | Southampton | United Kingdom | Unknown status |
| Re:Cognition Health - Winchester Coordinator of this site? Confirm its status | Winchester | United Kingdom | Unknown status |
| Enomoto Internal Medicine Clinic Coordinator of this site? Confirm its status | Chofu-shi | Japan | Unknown status |
| Tokyo Asbo Clinic Coordinator of this site? Confirm its status | Chūōku | Japan | Unknown status |
| Hatsuta Neurology Clinic Coordinator of this site? Confirm its status | Hirakata-shi | Japan | Unknown status |
| Kusunoki Clinic Coordinator of this site? Confirm its status | Kobe | Japan | Unknown status |
| Kobe City Medical Center General Hospital Coordinator of this site? Confirm its status | Kobe | Japan | Unknown status |
| Musashimurayama Hospital Coordinator of this site? Confirm its status | Musashimurayama | Japan | Unknown status |
| Saiseikai Narashino Hospital Coordinator of this site? Confirm its status | Narashino-shi | Japan | Unknown status |
| Higashi Shinjuku Clinic Coordinator of this site? Confirm its status | Shinjuku-ku | Japan | Unknown status |
| ToCROM Clinic Coordinator of this site? Confirm its status | Shinjuku Ku | Japan | Unknown status |
| Medical corporation Shinanokai Samoncho Clinic Coordinator of this site? Confirm its status | Shinjyuku Ku | Japan | Unknown status |
| OCROM Clinic Coordinator of this site? Confirm its status | Suita Shi | Japan | Unknown status |
| Jinsenkai MI Clinic Coordinator of this site? Confirm its status | Toyonaka-shi | Japan | Unknown status |
| Nagomi Clinic Coordinator of this site? Confirm its status | Toyonaka-shi | Japan | Unknown status |
| Skånes universitetssjukhus Coordinator of this site? Confirm its status | Malmö | Sweden | Unknown status |
| Karolinska universitetssjukhuset - Huddinge Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
| Neurological Associates of Albany, PC Coordinator of this site? Confirm its status | Albany | United States | Unknown status |
| JEM Research LLC Coordinator of this site? Confirm its status | Atlantis | United States | Unknown status |
| Memory Clinic, Inc. Coordinator of this site? Confirm its status | Bennington | United States | Unknown status |
| Excel Medical Clinical Trials, LLC Coordinator of this site? Confirm its status | Boca Raton | United States | Unknown status |
| Valley Medical Research Coordinator of this site? Confirm its status | Centerville | United States | Unknown status |
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| Great Lakes Clinical Trials Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| K2 Medical Research WINTER GARDEN Coordinator of this site? Confirm its status | Clermont | United States | Unknown status |
| Velocity Clinical Research East Syracuse Coordinator of this site? Confirm its status | East Syracuse | United States | Unknown status |
| QUEST Research Institute Coordinator of this site? Confirm its status | Farmington Hills | United States | Unknown status |
| Great Lakes Clinical Trials - Gurnee Coordinator of this site? Confirm its status | Gurnee | United States | Unknown status |
| Hattiesburg Clinic Coordinator of this site? Confirm its status | Hattiesburg | United States | Unknown status |
| Irvine Clinical Research Coordinator of this site? Confirm its status | Irvine | United States | Unknown status |
| Clinical NeuroScience Solutions Inc Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| K2 Medical Research Lady Lake Coordinator of this site? Confirm its status | Lady Lake | United States | Unknown status |
| K2 Medical Research - Maitland Coordinator of this site? Confirm its status | Maitland | United States | Unknown status |
| AMC Research, LLC Coordinator of this site? Confirm its status | Matthews | United States | Unknown status |
| Merritt Island Medical Research, LLC Coordinator of this site? Confirm its status | Merritt Island | United States | Unknown status |
| Esperanza Clinical Coordinator of this site? Confirm its status | Murrieta | United States | Unknown status |
| Yale University School Of Medicine Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| The Medical Research Network, LLC Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Headlands Research Orlando Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Xenoscience Inc. Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Keystone Clinical Studies, LLC Coordinator of this site? Confirm its status | Plymouth Meeting | United States | Unknown status |
| Butler Hospital Coordinator of this site? Confirm its status | Providence | United States | Unknown status |
| Artemis Institute for Clinical Research Riverside Coordinator of this site? Confirm its status | Riverside | United States | Unknown status |
| Clinical Trials of Texas Inc Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Artemis Institute for Clinical Research San Diego Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| The Cognitive and Research Center of New Jersey LLC Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Alzheimers Research and Treatment Center Stuart Coordinator of this site? Confirm its status | Stuart | United States | Unknown status |
| K2 Medical Research - Tampa Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Charter Research Coordinator of this site? Confirm its status | The Villages | United States | Unknown status |
| Alzheimers Research and Treatment Center - Wellington Coordinator of this site? Confirm its status | Wellington | United States | Unknown status |
| Palm Beach Neurology and Premier Research Institute Coordinator of this site? Confirm its status | West Palm Beach | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.