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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 55 Years and 75 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A: JNJ-64042056 		Participants will receive intramuscular (IM) injection of JNJ-64042056 from Week 0 until Week 180.
  • Drug: JNJ-64042056
    JNJ-64042056 will be administered intramuscularly.
Placebo Comparator
Arm B: Placebo 		Participants will receive IM injection of placebo from Week 0 until Week 180.
  • Drug: Placebo
    Placebo will be administered intramuscularly.

Recruiting Locations

Xenoscience Inc.
Phoenix 5308655, Arizona 5551752 85004

Irvine Clinical Research
Irvine 5359777, California 5332921 92614

Esperanza Clinical
Murrieta 5375911, California 5332921 92562

Artemis Institute for Clinical Research
Riverside 5387877, California 5332921 92503

Artemis Institute for Clinical Research
San Diego 5391811, California 5332921 92123

Yale University School Of Medicine
New Haven 4839366, Connecticut 4831725 06510

JEM Research LLC
Atlantis 4146372, Florida 4155751 33462

Excel Medical Clinical Trials, LLC
Boca Raton 4148411, Florida 4155751 33434

K2 Medical Research Winter Garden
Clermont 4151352, Florida 4155751 34711

Clinical NeuroScience Solutions Inc
Jacksonville 4160021, Florida 4155751 32256

K2 Medical Research
Lady Lake 4161118, Florida 4155751 32159

K2 Medical Research
Maitland 4163220, Florida 4155751 32751

Merritt Island Medical Research, LLC
Merritt Island 4164092, Florida 4155751 32952

Headlands Research Orlando
Orlando 4167147, Florida 4155751 32806

Alzheimers Research and Treatment Center
Stuart 4174201, Florida 4155751 34997

K2 Medical Research
Tampa 4174757, Florida 4155751 33634

Charter Research
The Villages 4175179, Florida 4155751 32162

Alzheimers Research and Treatment Center
Wellington 4177703, Florida 4155751 33414

Palm Beach Neurology and Premier Research Institute
West Palm Beach 4177887, Florida 4155751 33407

Great Lakes Clinical Trials
Chicago 4887398, Illinois 4896861 60640

Quest Research Institute
Farmington Hills 4992523, Michigan 5001836 48334

Hattiesburg Clinic
Hattiesburg 4429295, Mississippi 4436296 39401

The Cognitive and Research Center of New Jersey LLC
Springfield 5104952, New Jersey 5101760 07081

Neurological Associates of Albany, PC
Albany 5106834, New York 5128638 12208

Velocity Clinical Research
East Syracuse 5116079, New York 5128638 13057

The Medical Research Network, LLC
New York 5128581, New York 5128638 10128

AMC Research, LLC
Matthews 4478334, North Carolina 4482348 28105

Valley Medical Research
Centerville 4508204, Ohio 5165418 45459-2785

Keystone Clinical Studies LLC
Plymouth Meeting 5206666, Pennsylvania 6254927 19462

Butler Hospital
Providence 5224151, Rhode Island 5224323 02906

Clinical Trials of Texas Inc
San Antonio 4726206, Texas 4736286 78229

Memory Clinic Inc
Bennington 5233742, Vermont 5242283 05201

University of Virginia
Charlottesville 4752031, Virginia 6254928 22903

More Details

NCT ID
NCT06544616
Status
Recruiting
Sponsor
Janssen Pharmaceutica N.V., Belgium

Study Contact

Study Contact
844-434-4210
Participate-In-This-Study1@its.jnj.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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