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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Alzheimer Disease

In brief

The purpose of this study is to assess whether JNJ-64042056 affects the spread and build up of tau (a protein in brain) when compared with placebo, using brain scan (tau PET) to determine results from specific areas of the brain.

Key facts

Study ID

NCT06544616

Run by

Janssen Pharmaceutica N.V., Belgium

People needed

55

Starts

2024-07-22

Expected to finish

2027-01-05

Last updated by the study team

2026-07-31

Who can join

Age: 55 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Irvine Clinical Research — Irvine, California, United States
• Esperanza Clinical — Murrieta, California, United States
• Artemis Institute for Clinical Research Riverside — Riverside, California, United States
• Artemis Institute for Clinical Research San Diego — San Diego, California, United States
• Yale University School Of Medicine — New Haven, Connecticut, United States
• JEM Research LLC — Atlantis, Florida, United States
• Excel Medical Clinical Trials, LLC — Boca Raton, Florida, United States
• K2 Medical Research Winter Garden — Clermont, Florida, United States
• Clinical NeuroScience Solutions Inc — Jacksonville, Florida, United States
• K2 Medical Research Lady Lake — Lady Lake, Florida, United States
• K2 Medical Research Maitland — Maitland, Florida, United States
• Merritt Island Medical Research, LLC — Merritt Island, Florida, United States
• Headlands Research Orlando — Orlando, Florida, United States
• Alzheimers Research and Treatment Center Stuart — Stuart, Florida, United States
• K2 Medical Research Tampa — Tampa, Florida, United States
• Charter Research — The Villages, Florida, United States
• Alzheimers Research and Treatment Center Wellington — Wellington, Florida, United States
• Palm Beach Neurology and Premier Research Institute — West Palm Beach, Florida, United States
• Great Lakes Clinical Trials Chicago — Chicago, Illinois, United States
• Great Lakes Clinical Trials Gurnee — Gurnee, Illinois, United States
• Quest Research Institute — Farmington Hills, Michigan, United States
• Hattiesburg Clinic — Hattiesburg, Mississippi, United States
• The Cognitive and Research Center of New Jersey LLC — Springfield, New Jersey, United States
• Neurological Associates of Albany, PC — Albany, New York, United States
• Xenoscience Inc. — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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