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

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.

Conditions

Preclinical Alzheimer's Disease

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Preclinical Alzheimer's Disease
Intervention / Treatment

-

Contacts and Locations

Phoenix

Xenoscience Inc., Phoenix, Arizona, United States, 85004

Irvine

Irvine Clinical Research, Irvine, California, United States, 92614

Riverside

Artemis Institute for Clinical Research, Riverside, California, United States, 92503

San Diego

Artemis Institute for Clinical Research, San Diego, California, United States, 92103

Atlantis

JEM Research LLC, Atlantis, Florida, United States, 33462

Boca Raton

Excel Medical Clinical Trials, LLC, Boca Raton, Florida, United States, 33434

Clermont

K2 Medical Research Winter Garden, Clermont, Florida, United States, 34711

Jacksonville

Clinical NeuroScience Solutions Inc, Jacksonville, Florida, United States, 32256

Maitland

K2 Medical Research, Maitland, Florida, United States, 32751

Merritt Island

Merritt Island Medical Research, LLC, Merritt Island, Florida, United States, 32952

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

55 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Janssen Pharmaceutica N.V., Belgium,

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

Study Record Dates

2033-05-31