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Clinical Trials in the UK / NCT06544616
Active, not recruiting Phase 2

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

NCT06544616 · tracked via the Priya Life Science UK tracker
Sponsor
Janssen Pharmaceutica N.V., Belgium
Phase
Phase 2
Started
2024-07-22
Last updated
2026-08-28

Condition(s) studied

Alzheimer Disease

Investigational drug(s) / intervention(s)

JNJ-64042056Placebo

JNJ-64042056: JNJ-64042056 will be administered intramuscularly.

Placebo: Placebo will be administered intramuscularly.

Study summary

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.

Eligibility

Sex
ALL
Min age
55 Years
Max age
75 Years
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

Primary outcome measure(s)

Trial sites (90)

FacilityCityRegionStatus
Xenoscience Inc. Phoenix Arizona
Irvine Clinical Research Irvine California
Esperanza Clinical Murrieta California
Artemis Institute for Clinical Research Riverside Riverside California
Artemis Institute for Clinical Research San Diego San Diego California
Yale University School Of Medicine New Haven Connecticut
JEM Research LLC Atlantis Florida
Excel Medical Clinical Trials, LLC Boca Raton Florida
K2 Medical Research Winter Garden Clermont Florida
Clinical NeuroScience Solutions Inc Jacksonville Florida
K2 Medical Research Lady Lake Lady Lake Florida
K2 Medical Research Maitland Maitland Florida
Merritt Island Medical Research, LLC Merritt Island Florida
Headlands Research Orlando Orlando Florida
Alzheimers Research and Treatment Center Stuart Stuart Florida
K2 Medical Research Tampa Tampa Florida
Charter Research The Villages Florida
Alzheimers Research and Treatment Center Wellington Wellington Florida
Palm Beach Neurology and Premier Research Institute West Palm Beach Florida
Great Lakes Clinical Trials Chicago Chicago Illinois
Great Lakes Clinical Trials Gurnee Gurnee Illinois
Quest Research Institute Farmington Hills Michigan
Hattiesburg Clinic Hattiesburg Mississippi
The Cognitive and Research Center of New Jersey LLC Springfield New Jersey
Neurological Associates of Albany, PC Albany New York
Velocity Clinical Research East Syracuse East Syracuse New York
The Medical Research Network, LLC New York New York
AMC Research, LLC Matthews North Carolina
Valley Medical Research Centerville Ohio
Keystone Clinical Studies LLC Plymouth Meeting Pennsylvania
Butler Hospital Providence Rhode Island
Clinical Trials of Texas Inc San Antonio Texas
Memory Clinic Inc Bennington Vermont
University of Virginia Charlottesville Virginia
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

+ 50 more sites — see the full list on the official registry below.

More Janssen Pharmaceutica N.V., Belgium trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06544616 on ClinicalTrials.gov ↗ ← All trials in the UK