--- title: "A Study of JNJ-64042056 in Participants With Preclinical Alzheimer's Disease" nct_id: NCT06544616 overall_status: ACTIVE_NOT_RECRUITING phase: PHASE2 sponsor: Janssen Pharmaceutica N.V., Belgium study_type: INTERVENTIONAL primary_condition: "Preclinical Alzheimer's Disease" countries: United States, Australia, Belgium, France, Germany, Japan, Spain, Sweden, United Kingdom canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06544616.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06544616" ct_last_update_post_date: 2026-02-17 last_seen_at: "2026-05-12T07:27:27.785Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # A Study of JNJ-64042056 in Participants With Preclinical Alzheimer's Disease **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 **NCT ID:** [NCT06544616](https://clinicaltrials.gov/study/NCT06544616) ## Key Facts - **Status:** ACTIVE_NOT_RECRUITING - **Phase:** PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 498 - **Lead Sponsor:** Janssen Pharmaceutica N.V., Belgium - **Conditions:** Preclinical Alzheimer's Disease - **Start Date:** 2024-07-22 - **Completion Date:** 2032-07-16 - **CT.gov Last Update:** 2026-02-17 ## Brief 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 - **Minimum age:** 55 Years - **Maximum age:** 75 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: * 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 Exclusion Criteria: * History consistent with or known autosomal dominant AD (mutation identified in the family 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 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) * Vitamin B12 or folate levels below the central laboratory lower limit of normal, unless the investigator determines that supplementation is not required after randomization * History of or current neurological disease other than preclinical AD that may make interpretation of possible new neurological signs or symptoms difficult ``` ## Arms - **Arm A: JNJ-64042056** (EXPERIMENTAL) — Participants will receive intramuscular (IM) injection of JNJ-64042056 from Week 0 until Week 180. - **Arm B: Placebo** (PLACEBO_COMPARATOR) — Participants will receive IM injection of placebo from Week 0 until Week 180. ## Interventions - **JNJ-64042056** (DRUG) — JNJ-64042056 will be administered intramuscularly. - **Placebo** (DRUG) — Placebo will be administered intramuscularly. ## Primary Outcomes - **Change From Baseline in Preclinical Alzheimer's Disease Cognitive Composite 5 (PACC-5) Total Scores up to Week 206** _(time frame: Baseline up to Week 206)_ — Cognition will be measured using the PACC-5 scale, which includes 5 components: free/cued selective reminding test, delayed paragraph recall (logical memory test), digit-symbol substitution test, mini mental state examination, and the category fluency test (CFT). PACC-5 is a composite score which provides unique information about early cognitive decline not currently captured by the episodic memory, executive function, and global cognition components. The total score is a sum of z-score, with higher scores indicating better cognitive performance. ## Secondary Outcomes - **Change From Baseline in Brain tau Burden as Measured by tau PET** _(time frame: Baseline and Weeks 102, 154 and 206)_ - **Change From Baseline in PACC-5 Individual Domain Scores** _(time frame: Baseline up to Week 206)_ - **Time to Event of Clinical Progression as Measured by Clinical Dementia Rating-Global Score (CDR-GS)** _(time frame: Baseline up to Week 206)_ - **Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Scores** _(time frame: Baseline up to Week 206)_ - **Change from Baseline in Tau PET Standardized Uptake Value Ratio (SUVR) Biomarkers** _(time frame: Baseline up to Week 206)_ - **Change From Baseline in p217+tau** _(time frame: Baseline up to Week 206)_ - **Change From Baseline in PACC-5 Total Score** _(time frame: Baseline up to Week 180)_ - **Change From Baseline in Brain Tau Burden as Measured by Tau PET in Other ROI** _(time frame: Baseline up to Week 206)_ - **Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living -Prevention Instrument (ADCS-ADL-PI)** _(time frame: Baseline up to Week 206)_ - **Change From Baseline in Mild Behavioral Impairment Checklist (MBI-C) Score** _(time frame: Baseline up to Week 206)_ - **Change From Baseline in the Quality of Life- Alzheimer's Disease (QoL-AD)** _(time frame: Baseline up to Week 206)_ - **Change From Baseline in European Quality of Life-5 Dimensions 5-Levels (EQ-5D-5L) Score** _(time frame: Baseline up to Week 206)_ - **Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite) Score** _(time frame: Baseline up to Week 206)_ - **Levels of IgG Titers Against Enriched Paired Helical Filaments (ePHF), p-tau and tau in Serum** _(time frame: Up to Week 206)_ - **Number of Participants With Treatment Emergent Adverse Events (TEAEs)** _(time frame: Up to Week 208)_ - **Number of Participants With Reactogenicity** _(time frame: Up to Week 182)_ - **Change from Baseline in Vital Signs** _(time frame: Baseline up to Week 180)_ - **Change From Baseline in Clinical Laboratory Values** _(time frame: Baseline up to Week 206)_ - **Change from Baseline in Electrocardiogram (ECG) Values** _(time frame: Baseline up to Week 206)_ - **Change From Baseline in Columbia-Suicidality Severity Rating Scale (C-SSRS)** _(time frame: Baseline up to Week 206)_ - **Change From Baseline in Magnetic Resonance Imaging (MRI) Findings** _(time frame: Baseline up to Week 206)_ ## 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, Malmö, 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 ## Recent Field Changes (last 30 days) - `locations.re-cognition health|winchester||united kingdom` — added _(2026-05-12)_ - `locations.southampton general hospital|southampton||united kingdom` — added _(2026-05-12)_ - `locations.moorgreen hospital memory assessment and research centre|southampton||united kingdom` — added _(2026-05-12)_ - `locations.re-cognition health|plymouth||united kingdom` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.xenoscience inc.|phoenix|arizona|united states` — added _(2026-05-12)_ - `locations.irvine clinical research|irvine|california|united states` — added _(2026-05-12)_ - `locations.esperanza clinical|murrieta|california|united states` — added _(2026-05-12)_ - `locations.artemis institute for clinical research|riverside|california|united states` — added _(2026-05-12)_ - `locations.artemis institute for clinical research|san diego|california|united states` — added _(2026-05-12)_ - `locations.yale university school of medicine|new haven|connecticut|united states` — added _(2026-05-12)_ - `locations.jem research llc|atlantis|florida|united states` — added _(2026-05-12)_ - `locations.excel medical clinical trials, llc|boca raton|florida|united states` — added _(2026-05-12)_ - `locations.k2 medical research winter garden|clermont|florida|united states` — added _(2026-05-12)_ - `locations.clinical neuroscience solutions inc|jacksonville|florida|united states` — added _(2026-05-12)_ - `locations.k2 medical research|lady lake|florida|united states` — added _(2026-05-12)_ - `locations.k2 medical research|maitland|florida|united states` — added _(2026-05-12)_ - `locations.merritt island medical research, llc|merritt island|florida|united states` — added _(2026-05-12)_ - `locations.headlands research orlando|orlando|florida|united states` — added _(2026-05-12)_ - `locations.alzheimers research and treatment center|stuart|florida|united states` — added _(2026-05-12)_ - `locations.k2 medical research|tampa|florida|united states` — added _(2026-05-12)_ - `locations.charter research|the villages|florida|united states` — added _(2026-05-12)_ - `locations.alzheimers research and treatment center|wellington|florida|united states` — added _(2026-05-12)_ - `locations.palm beach neurology and premier research institute|west palm beach|florida|united states` — added _(2026-05-12)_ - `locations.great lakes clinical trials|chicago|illinois|united states` — added _(2026-05-12)_ - `locations.great lakes clinical trials|gurnee|illinois|united states` — added _(2026-05-12)_ - `locations.quest research institute|farmington hills|michigan|united states` — added _(2026-05-12)_ - `locations.hattiesburg clinic|hattiesburg|mississippi|united states` — added _(2026-05-12)_ - `locations.the cognitive and research center of new jersey llc|springfield|new jersey|united states` — added _(2026-05-12)_ - `locations.neurological associates of albany, pc|albany|new york|united states` — added _(2026-05-12)_ - `locations.velocity clinical research|east syracuse|new york|united states` — added _(2026-05-12)_ - `locations.the medical research network, llc|new york|new york|united states` — added _(2026-05-12)_ - `locations.amc research, llc|matthews|north carolina|united states` — added _(2026-05-12)_ - `locations.valley medical research|centerville|ohio|united states` — added _(2026-05-12)_ - `locations.keystone clinical studies llc|plymouth meeting|pennsylvania|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT06544616.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT06544616* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*