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.
Eligibility
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