RECRUITING

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

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Conditions

Preclinical Alzheimer's Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-07-22
Study Completion:2033-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06544616

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Clinical Dementia Rating (CDR) global score of 0 at screening and baseline
  3. * Mini Mental State Examination (MMSE) greater than or equal to (\>=) 27 (with educational adjustment)
  4. * Able to read and write and with a minimum 5 years of formal education as reported by participant and study partner at screening
  5. * A participant must be of non-childbearing potential
  1. * History consistent with or known autosomal dominant AD (mutation identified in the family and/or participant)
  2. * 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
  3. * Diagnosis of Mild Cognitive Impairment (MCI)
  4. * 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
  5. * History of or current neurological disease other than preclinical AD that may make interpretation of possible new neurological signs or symptoms difficult

Contacts and Locations

Study Contact

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

Principal Investigator

Janssen Pharmaceutica N.V., Belgium Clinical trial
STUDY_DIRECTOR
Janssen Pharmaceutica N.V., Belgium

Study Locations (Sites)

Xenoscience Inc.
Phoenix, Arizona, 85004
United States
Irvine Clinical Research
Irvine, California, 92614
United States
Artemis Institute for Clinical Research
Riverside, California, 92503
United States
Artemis Institute for Clinical Research
San Diego, California, 92103
United States
JEM Research LLC
Atlantis, Florida, 33462
United States
Excel Medical Clinical Trials, LLC
Boca Raton, Florida, 33434
United States
K2 Medical Research Winter Garden
Clermont, Florida, 34711
United States
Clinical NeuroScience Solutions Inc
Jacksonville, Florida, 32256
United States
K2 Medical Research
Maitland, Florida, 32751
United States
Merritt Island Medical Research, LLC
Merritt Island, Florida, 32952
United States
Headlands Research Orlando
Orlando, Florida, 32819
United States
Alzheimers Research and Treatment Center
Stuart, Florida, 34997
United States
K2 Medical Research
Tampa, Florida, 33607
United States
K2 Medical Research
The Villages, Florida, 32159
United States
Charter Research
The Villages, Florida, 32162
United States
Alzheimers Research and Treatment Center
Wellington, Florida, 33414
United States
Palm Beach Neurology and Premier Research Institute
West Palm Beach, Florida, 33407
United States
Great Lakes Clinical Trials
Chicago, Illinois, 60640
United States
Great Lakes Clinical Trials
Gurnee, Illinois, 60031
United States
Quest Research Institute
Farmington Hills, Michigan, 48334
United States
Hattiesburg Clinic
Hattiesburg, Mississippi, 39401
United States
Neurological Associates of Albany, PC
Albany, New York, 12208
United States
Velocity Clinical Research
East Syracuse, New York, 13057
United States
AMC Research, LLC
Matthews, North Carolina, 28105
United States
Valley Medical Research
Centerville, Ohio, 45459-2785
United States
Keystone Clinical Studies LLC
Plymouth Meeting, Pennsylvania, 19462
United States
Butler Hospital
Providence, Rhode Island, 02906
United States
Clinical Trials of Texas Inc
San Antonio, Texas, 78229
United States
Memory Clinic Inc
Bennington, Vermont, 05201
United States
University of Virginia
Charlottesville, Virginia, 22903
United States

Collaborators and Investigators

Sponsor: Janssen Pharmaceutica N.V., Belgium

  • Janssen Pharmaceutica N.V., Belgium Clinical trial, STUDY_DIRECTOR, Janssen Pharmaceutica N.V., Belgium

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-22
Study Completion Date2033-05-31

Study Record Updates

Study Start Date2024-07-22
Study Completion Date2033-05-31

Terms related to this study

Additional Relevant MeSH Terms

  • Preclinical Alzheimer's Disease