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

Summary

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.

Eligibility

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

Conditions1

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