Active — Not RecruitingPhase 2

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

United States, Australia, Belgium55 participantsStarted 2024-07-22

Plain-language summary

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.

Who can participate

Age range

55 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 possib…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is measuring changes in tau buildup in the brain using a PET scan — can you help me understand what tau burden means for my situation and whether my current scan results would be relevant to what this study is tracking?
2Since this is a Phase 2 trial, the safety and effectiveness of JNJ-64042056 in people haven't been fully established yet — what do you think is known so far about its safety profile, and how does that uncertainty compare to simply monitoring my condition without treatment?
3The trial is listed as 'active not recruiting,' which means they're no longer enrolling new participants — are there any similar trials studying tau-targeting approaches in preclinical Alzheimer's that I might still be able to join?
4This study focuses on people with preclinical Alzheimer's disease, meaning before symptoms appear — given where I am in my diagnosis, do you think participating in a tau-focused study like this would be appropriate for me, or would a different type of intervention make more sense at this stage?
5Tau PET scans are being used as the main measurement tool in this trial — would I need that kind of imaging as part of my regular care anyway, and how does that affect whether a study like this would fit into my current care plan?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change From Baseline in Brain Tau Burden as Measured by Tau PET in Specified Regions of Interest (ROI)

Timeframe: Baseline up to Week 102

Trial details

NCT IDNCT06544616

SponsorJanssen Pharmaceutica N.V., Belgium

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-22

View on ClinicalTrials.gov More Alzheimer Disease trials

Who can participate

Age range

55 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.