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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-505096-68-00 | Registry Identifier | EUCT number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: JNJ-64042056 | Experimental | Participants will receive intramuscular (IM) injection of JNJ-64042056 from Week 0 up to a maximum of Week 76. |
|
| Arm B: Placebo | Placebo Comparator | Participants will receive IM injection of placebo from Week 0 up to a maximum of Week 76. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-64042056 | Drug | JNJ-64042056 will be administered intramuscularly. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Brain Tau Burden as Measured by Tau PET in Specified Regions of Interest (ROI) | Change from baseline in brain tau burden, as measured by tau PET (including but not limited to Braak I-VI ROIs, tau naive composite ROI, Connection Rank ROI, and New Tau Composite ROI Volume) will be reported. | Baseline up to Week 102 |
| Measure | Description | Time Frame |
|---|---|---|
| Levels of IgG Titers Against Enriched Paired Helical Filaments (ePHF), p-tau and tau in Serum | Levels of IgG titers against ePHF, p-tau peptide and tau peptide in serum will be measured. | Up to Week 102 |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutica N.V., Belgium Clinical trial | Janssen Pharmaceutica N.V., Belgium | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xenoscience Inc. | Phoenix | Arizona | 85004 | United States | ||
| Irvine Clinical Research |
The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.jnj.com/innovativemedicine/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
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| Placebo |
| Drug |
Placebo will be administered intramuscularly. |
|
An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the pharmaceutical or biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment. |
| Up to Week 104 |
| Number of Participants With Reactogenicity | Solicited AEs will be used to assess the reactogenicity of the active immunotherapy and are predefined local (at the injection site) and systemic events for which the participant is specifically questioned, and which are noted by participants in their participant diary. | Up to Week 78 |
| Number of Participants with Vital Signs Abnormalities | Participants with vital signs abnormalities including temperature and blood pressure (systolic and diastolic) (supine) will be summarized over time. | Up to Week 102 |
| Number of Participants with Clinical Laboratory Abnormalities | Participants with clinical laboratory abnormalities values (chemistry, hematology, urinalysis and coagulation) will be reported. | Up to Week 102 |
| Change from Baseline in Electrocardiogram (ECG) Values | Change from baseline in ECG values will be reported. | Baseline up to Week 102 |
| Change From Baseline in Columbia-Suicidality Severity Rating Scale (C-SSRS) | A frequency distribution of C-SSRS scores at each scheduled time point by treatment will be provided. Shifts from the baseline visit to the most severe/maximum score during the treatment period will be summarized by treatment. The maximum score assigned for each participant will also be summarized into 1 of 3 categories: no suicidal ideation or behavior (0), suicidal ideation (1 to 5), suicidal behavior (6 to 10). | Baseline up to Week 102 |
| Change From Baseline in Magnetic Resonance Imaging (MRI) Findings | Change from baseline in brain MRI safety findings will be reported. | Baseline up to Week 102 |
| Irvine |
| California |
| 92614 |
| United States |
| Esperanza Clinical | Murrieta | California | 92562 | United States |
| Artemis Institute for Clinical Research Riverside | Riverside | California | 92503 | United States |
| Artemis Institute for Clinical Research San Diego | San Diego | California | 92123 | United States |
| Yale University School Of Medicine | New Haven | Connecticut | 06510 | United States |
| JEM Research LLC | Atlantis | Florida | 33462 | United States |
| Excel Medical Clinical Trials, LLC | Boca Raton | Florida | 33434 | United States |
| K2 Medical Research Winter Garden | Clermont | Florida | 34711 | United States |
| Clinical NeuroScience Solutions Inc | Jacksonville | Florida | 32256 | United States |
| K2 Medical Research Lady Lake | Lady Lake | Florida | 32159 | United States |
| K2 Medical Research Maitland | Maitland | Florida | 32751 | United States |
| Merritt Island Medical Research, LLC | Merritt Island | Florida | 32952 | United States |
| Headlands Research Orlando | Orlando | Florida | 32806 | United States |
| Alzheimers Research and Treatment Center Stuart | Stuart | Florida | 34997 | United States |
| K2 Medical Research Tampa | Tampa | Florida | 33634 | United States |
| Charter Research | The Villages | Florida | 32162 | United States |
| Alzheimers Research and Treatment Center Wellington | Wellington | Florida | 33414 | United States |
| Palm Beach Neurology and Premier Research Institute | West Palm Beach | Florida | 33407 | United States |
| Great Lakes Clinical Trials Chicago | Chicago | Illinois | 60640 | United States |
| Great Lakes Clinical Trials Gurnee | Gurnee | Illinois | 60031 | United States |
| Quest Research Institute | Farmington Hills | Michigan | 48334 | United States |
| Hattiesburg Clinic | Hattiesburg | Mississippi | 39401 | United States |
| The Cognitive and Research Center of New Jersey LLC | Springfield | New Jersey | 07081 | United States |
| Neurological Associates of Albany, PC | Albany | New York | 12208 | United States |
| Velocity Clinical Research East Syracuse | East Syracuse | New York | 13057 | United States |
| The Medical Research Network, LLC | New York | New York | 10128 | United States |
| AMC Research, LLC | Matthews | North Carolina | 28105 | United States |
| Valley Medical Research | Centerville | Ohio | 45459-2785 | United States |
| Keystone Clinical Studies LLC | Plymouth Meeting | Pennsylvania | 19462 | United States |
| Butler Hospital | Providence | Rhode Island | 02906 | United States |
| Clinical Trials of Texas Inc | San Antonio | Texas | 78229 | United States |
| Memory Clinic Inc | Bennington | Vermont | 05201 | United States |
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
| Neuro Trials Victoria | Carlton | 3053 | Australia |
| The Prince Charles Hospital | Chermside | 4032 | Australia |
| St Vincent's Centre for Applied Medical Research | Darlinghurst | 2010 | Australia |
| Austin Health Heidelberg Repatriation Hospital | Ivanhoe | 3079 | Australia |
| Southern Neurology | Kogarah | 2217 | Australia |
| KaRa Institute of Neurological Diseases | Macquarie Park | 2113 | Australia |
| Alzheimers Research Australia | Nedlands | 6009 | Australia |
| Az Groeninge | Kortrijk | 8500 | Belgium |
| Hopital Roger Salengro - CHU Lille | Lille | 59037 | France |
| Hopital Nord Laennec CHU NANTES | Nantes | 44800 | France |
| Hopital Lariboisiere-Fernand Widal | Paris | 75010 | France |
| CHU Pitie Salpetriere | Paris | 75013 | France |
| CHU Toulouse - Hôpital La Grave | Toulouse | 31059 | France |
| CHRU Tours Hopital Bretonneau | Tours | 37000 | France |
| Universitaetsklinikum der RWTH Aachen | Aachen | 52074 | Germany |
| Universitaetsklinikum Koeln | Cologne | 50937 | Germany |
| Universitaetsklinikum des Saarlandes | Homburg | 66421 | Germany |
| Universitatsklinikum Munster | Münster | 48149 | Germany |
| Enomoto Internal Medicine Clinic | Chofu-shi | 1820036 | Japan |
| Tokyo Asbo Clinic | Chūōku | 104-0031 | Japan |
| Hatsuta Neurology Clinic | Hirakata-shi | 573-1121 | Japan |
| Kobe City Medical Center General Hospital | Kobe | 650 0047 | Japan |
| Kusunoki Clinic | Kobe | 650-0044 | Japan |
| Musashimurayama Hospital | Musashimurayama | 208-0022 | Japan |
| Saiseikai Narashino Hospital | Narashino-shi | 275-8580 | Japan |
| ToCROM Clinic | Shinjuku Ku | 160 0008 | Japan |
| Higashi-Shinjuku Clinic | Shinjuku-ku | 169-0072 | Japan |
| Medical corporation Shinanokai Samoncho Clinic | Shinjyuku Ku | 160 0017 | Japan |
| OCROM Clinic | Suita Shi | 565 0853 | Japan |
| Nagomi Clinic | Toyonaka-shi | 560-0004 | Japan |
| Jinsenkai MI Clinic | Toyonaka-shi | 5600004 | Japan |
| Barcelona Beta Brain Research Center | Barcelona | 08005 | Spain |
| Fund. Ace-Inst. Cat. Neuroc. Aplicades | Barcelona | 08028 | Spain |
| Hosp Clinic de Barcelona | Barcelona | 08036 | Spain |
| Centro At. Esp. Oroitu | Getxo | 48993 | Spain |
| Hosp. Univ. Santa Maria | Lleida | 25198 | Spain |
| Hosp. Clinico San Carlos | Madrid | 28040 | Spain |
| Clinica Univ. de Navarra | Pamplona | 31008 | Spain |
| Hosp. Quiron Madrid Pozuelo | Pozuelo de Alarcón | 28223 | Spain |
| Idc Salud Hosp. Gral. de Catalunya | Sant Cugat del Vallès | 08190 | Spain |
| Hosp. Mutua Terrassa | Terrassa | 08222 | Spain |
| Hosp. Viamed Montecanal | Zaragoza | 50012 | Spain |
| Skanes universitetssjukhus | Malmö | 20502 | Sweden |
| Karolinska Universitetssjukhuset Huddinge | Stockholm | 14186 | Sweden |
| Royal United Hospital | Bath | BA1 3NG | United Kingdom |
| Re-Cognition Health Birmingham | Birmingham | B16 8LT | United Kingdom |
| Re-Cognition Health Bristol | Bristol | BS32 4SY | United Kingdom |
| Scottish Brain Sciences | Edinburgh | EH12 5PJ | United Kingdom |
| Re-Cognition Health Guildford | Guildford | GU2 7YD | United Kingdom |
| Re-Cognition Health London | London | W1G 8TA | United Kingdom |
| Kings College Hospital | London | WC2R 2LS | United Kingdom |
| University of Oxford | Oxford | OX3 7JX | United Kingdom |
| Re-Cognition Health Plymouth | Plymouth | PL6 8BT | United Kingdom |
| Moorgreen Hospital Memory Assessment And Research Centre | Southampton | S03 3JB | United Kingdom |
| Southampton General Hospital | Southampton | SO16 6YD | United Kingdom |
| Re-Cognition Health Winchester | Winchester | SO23 8SR | United Kingdom |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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