Status:
RECRUITING
A Study of JNJ-64042056 in Participants With Preclinical Alzheimer's Disease
Lead Sponsor:
Janssen Pharmaceutica N.V., Belgium
Conditions:
Preclinical Alzheimer's Disease
Eligibility:
All Genders
55-75 years
Phase:
PHASE2
Brief 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 Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 7 2034
Estimated Enrollment :
498 Patients enrolled
Trial Details
Trial ID
NCT06544616
Start Date
July 22 2024
End Date
June 7 2034
Last Update
December 19 2025
Active Locations (90)
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1
Xenoscience Inc.
Phoenix, Arizona, United States, 85004
2
Irvine Clinical Research
Irvine, California, United States, 92614
3
Esperanza Clinical
Murrieta, California, United States, 92562
4
Artemis Institute for Clinical Research
Riverside, California, United States, 92503