Clinical trial NCT06544616: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Preclinical Alzheimer's Disease
Lead sponsor: Janssen Pharmaceutica N.V., Belgium
Sponsor class: INDUSTRY
First posted: 2024-08-09
Enrollment: 498
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 criteria: Inclusion Criteria:

* Elevated brain tau pathology defined as Braak 3 region of interest standardized uptake value ratio (ROI SUVR) greater than (\>) 1.1 on a screening tau PET scan, reviewed centrally by a qualified reader
* 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)
* 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 in the opinion of the investigator it does not require treatment
* History of or current neurological disease other than preclinical AD that may make interpretation of possible new neurological signs or symptoms difficult

Primary outcomes:
measure: Change From Baseline in Preclinical Alzheimer's Disease Cognitive Composite 5 (PACC-5) Total Scores up to Week 206
timeFrame: Baseline up to Week 206
Secondary outcomes:
measure: Change From Baseline in Brain tau Burden as Measured by tau PET
timeFrame: Baseline and Weeks 102, 154 and 206
measure: Change From Baseline in PACC-5 Individual Domain Scores
timeFrame: Baseline up to Week 206
measure: Time to Event of Clinical Progression as Measured by Clinical Dementia Rating-Global Score (CDR-GS)
timeFrame: Baseline up to Week 206
measure: Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Scores
timeFrame: Baseline up to Week 206
measure: Change from Baseline in Tau PET Standardized Uptake Value Ratio (SUVR) Biomarkers (tau Naive Composite ROI and Other ROIs)
timeFrame: Baseline up to Week 206
measure: Change From Baseline in p217+tau
timeFrame: Baseline up to Week 206
measure: Change From Baseline in PACC-5 Total Score
timeFrame: Baseline up to Week 180
measure: Change From Baseline in Brain Tau Burden as Measured by Tau PET in Other ROI
timeFrame: Baseline up to Week 206
measure: Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living -Prevention Instrument (ADCS-ADL-PI)
timeFrame: Baseline up to Week 206
measure: Change From Baseline in Mild Behavioral Impairment Checklist (MBI-C) Score
timeFrame: Baseline up to Week 206
measure: Change From Baseline in the Quality of Life- Alzheimer's Disease (QoL-AD)
timeFrame: Baseline up to Week 206
measure: Change From Baseline in European Quality of Life-5 Dimensions 5-Levels (EQ-5D-5L) Score
timeFrame: Baseline up to Week 206
measure: Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite) Score
timeFrame: Baseline up to Week 206
measure: Levels of IgG Titers Against Enriched Paired Helical Filaments (ePHF), p-tau and tau in Serum
timeFrame: Up to Week 206
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: Up to Week 208
measure: Number of Participants With Reactogenicity
timeFrame: Up to Week 182
measure: Change from Baseline in Vital Signs
timeFrame: Baseline up to Week 206
measure: Change From Baseline in Clinical Laboratory Values
timeFrame: Baseline up to Week 206
measure: Change from Baseline in Electrocardiogram (ECG) Values
timeFrame: Baseline up to Week 206
measure: Change From Baseline in Columbia-Suicidality Severity Rating Scale (C-SSRS)
timeFrame: Baseline up to Week 206
measure: Change From Baseline in Magnetic Resonance Imaging (MRI) Findings
timeFrame: Baseline up to Week 206
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Xenoscience Inc.
state: Arizona
city: Irvine
country: United States
facility: Irvine Clinical Research
state: California
city: Riverside
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Atlantis
country: United States
facility: JEM Research LLC
state: Florida
city: Boca Raton
country: United States
facility: Excel Medical Clinical Trials, LLC
state: Florida
city: Clermont
country: United States
facility: K2 Medical Research Winter Garden
state: Florida
city: Jacksonville
country: United States
facility: Clinical NeuroScience Solutions Inc
state: Florida
city: Lady Lake
country: United States
facility: K2 Medical Research
state: Florida
city: Maitland
country: United States
facility: K2 Medical Research
state: Florida
city: Merritt Island
country: United States
facility: Merritt Island Medical Research, LLC
state: Florida
city: Orlando
country: United States
facility: Headlands Research Orlando
state: Florida
city: Stuart
country: United States
facility: Alzheimers Research and Treatment Center
state: Florida
city: Tampa
country: United States
facility: K2 Medical Research
state: Florida
city: The Villages
country: United States
facility: Charter Research
state: Florida
city: Wellington
country: United States
facility: Alzheimers Research and Treatment Center
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Neurology and Premier Research Institute
state: Florida
city: Chicago
country: United States
facility: Great Lakes Clinical Trials
state: Illinois
city: Gurnee
country: United States
facility: Great Lakes Clinical Trials
state: Illinois
city: Farmington Hills
country: United States
facility: Quest Research Institute
state: Michigan
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic
state: Mississippi
city: Springfield
country: United States
facility: The Cognitive and Research Center of New Jersey LLC
state: New Jersey
city: Albany
country: United States
facility: Neurological Associates of Albany, PC
state: New York
city: East Syracuse
country: United States
facility: Velocity Clinical Research
state: New York
city: New York
country: United States
facility: The Medical Research Network, LLC
state: New York
city: Matthews
country: United States
facility: AMC Research, LLC
state: North Carolina
city: Centerville
country: United States
facility: Valley Medical Research
state: Ohio
city: Plymouth Meeting
country: United States
facility: Keystone Clinical Studies LLC
state: Pennsylvania
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
city: San Antonio
country: United States
facility: Clinical Trials of Texas Inc
state: Texas
city: Bennington
country: United States
facility: Memory Clinic Inc
state: Vermont
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Carlton
country: Australia
facility: Neuro Trials Victoria
city: Chermside
country: Australia
facility: The Prince Charles Hospital
city: Darlinghurst
country: Australia
facility: St Vincent's Centre for Applied Medical Research
city: Ivanhoe
country: Australia
facility: Austin Health Heidelberg Repatriation Hospital
city: Kogarah
country: Australia
facility: Southern Neurology
city: Macquarie Park
country: Australia
facility: KaRa Institute of Neurological Diseases
city: Nedlands
country: Australia
facility: Australian Alzheimer's Research Foundation Incorporated
city: Toulouse
country: France
facility: CHU Toulouse - Hôpital La Grave
city: Chofu-shi
country: Japan
facility: Enomoto Internal Medicine Clinic
city: Chuo-ku
country: Japan
facility: Tokyo Asbo Clinic
city: Hirakata-shi
country: Japan
facility: Hatsuta Neurology Clinic
city: Kobe City
country: Japan
facility: Kobe City Medical Center General Hospital
city: Kobe
country: Japan
facility: Kusunoki Clinic
city: Musashimurayama
country: Japan
facility: Musashimurayama Hospital
city: Narashino-shi
country: Japan
facility: Saiseikai Narashino Hospital
city: Shinjuku ku
country: Japan
facility: ToCROM Clinic
city: Shinjuku-ku
country: Japan
facility: Higashi-Shinjuku Clinic
city: Shinjyuku Ku
country: Japan
facility: Medical corporation Shinanokai Samoncho Clinic
city: Suita shi
country: Japan
facility: OCROM Clinic
city: Toyonaka-shi
country: Japan
facility: Nagomi Clinic
city: Toyonaka-shi
country: Japan
facility: Jinsenkai MI Clinic
city: Barcelona
country: Spain
facility: Barcelona Beta Brain Research Center
city: Barcelona
country: Spain
facility: Fund. Ace-Inst. Cat. Neuroc. Aplicades
city: Barcelona
country: Spain
facility: Hosp Clinic de Barcelona
city: Getxo
country: Spain
facility: Centro At. Esp. Oroitu
city: Madrid
country: Spain
facility: Hosp. Clinico San Carlos
city: Pamplona
country: Spain
facility: Clinica Univ. de Navarra
city: Pozuelo de Alarcón
country: Spain
facility: Hosp. Quiron Madrid Pozuelo
city: Terrassa
country: Spain
facility: Hosp. Mutua Terrassa
city: Zaragoza
country: Spain
facility: Hosp. Viamed Montecanal
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Huddinge
city: Bath
country: United Kingdom
facility: Royal United Hospital
city: Birmingham
country: United Kingdom
facility: Re-Cognition Health
city: Bristol
country: United Kingdom
facility: Re-Cognition Health
city: Edinburgh
country: United Kingdom
facility: Scottish Brain Sciences
city: Guildford
country: United Kingdom
facility: Re-Cognition Health
city: London
country: United Kingdom
facility: Re-Cognition Health
city: London
country: United Kingdom
facility: Kings College Hospital
city: Oxford
country: United Kingdom
facility: University of Oxford
city: Plymouth
country: United Kingdom
facility: Re-Cognition Health
city: Southampton
country: United Kingdom
facility: Moorgreen Hospital Memory Assessment And Research Centre
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
city: Winchester
country: United Kingdom
facility: Re-Cognition Health
Study officials:
affiliation: Janssen Pharmaceutica N.V., Belgium
name: Janssen Pharmaceutica N.V., Belgium Clinical trial
role: STUDY_DIRECTOR
References: