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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 Genders
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 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

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, Arizona 85004

Irvine Clinical Research
Irvine, California 92614

Artemis Institute for Clinical Research
Riverside, California 92503

Artemis Institute for Clinical Research
San Diego, California 92103

JEM Research LLC
Atlantis, Florida 33462

Excel Medical Clinical Trials, LLC
Boca Raton, Florida 33434

K2 Medical Research Winter Garden
Clermont, Florida 34711

Clinical NeuroScience Solutions Inc
Jacksonville, Florida 32256

K2 Medical Research
Lady Lake, Florida 32159

K2 Medical Research
Maitland, Florida 32751

Merritt Island Medical Research, LLC
Merritt Island, Florida 32952

Headlands Research Orlando
Orlando, Florida 32819

Alzheimers Research and Treatment Center
Stuart, Florida 34997

K2 Medical Research
Tampa, Florida 33607

Charter Research
The Villages, Florida 32162

Alzheimers Research and Treatment Center
Wellington, Florida 33414

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

Great Lakes Clinical Trials
Chicago, Illinois 60640

Great Lakes Clinical Trials
Gurnee, Illinois 60031

Quest Research Institute
Farmington Hills, Michigan 48334

Hattiesburg Clinic
Hattiesburg, Mississippi 39401

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

Neurological Associates of Albany, PC
Albany, New York 12208

Velocity Clinical Research
East Syracuse, New York 13057

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

AMC Research, LLC
Matthews, North Carolina 28105

Valley Medical Research
Centerville, Ohio 45459-2785

Keystone Clinical Studies LLC
Plymouth Meeting, Pennsylvania 19462

Butler Hospital
Providence, Rhode Island 02906

Clinical Trials of Texas Inc
San Antonio, Texas 78229

Memory Clinic Inc
Bennington, Vermont 05201

University of Virginia
Charlottesville, Virginia 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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