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

Preclinical Alzheimer's Disease
Clinicaltrials.gov:
EU CTIS:
#2023-505096-68-00
Other:
#64042056ALZ2001
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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

Note: The criteria listed here are only a general guide. To join any trial, you must first have a medical check by a qualified doctor or healthcare professional. They will decide if the trial is a good fit and safe for your health.
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