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Evaluating JNJ-64042056 for early Alzheimer's disease

A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study, to Assess Efficacy, Safety and Immunogenicity of JNJ-64042056, a Phosphorylated Tau Targeted Active Immunotherapy, in Participants With Preclinical Alzheimer's Disease

Phase 2 Interventional Janssen Pharmaceutica N.V., Belgium · NCT06544616

This study is testing a new drug called JNJ-64042056 to see if it can help people with early signs of Alzheimer's disease keep their thinking skills from getting worse.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment498 (estimated)
Ages55 Years to 75 Years
SexAll
SponsorJanssen Pharmaceutica N.V., Belgium Industry-sponsored
Locations75 sites (Phoenix, Arizona and 74 other locations)
Trial IDNCT06544616 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effects of JNJ-64042056 on cognitive decline in individuals with preclinical Alzheimer's disease. Participants will be assessed using the Preclinical Alzheimer's disease Cognitive Composite 5 (PACC-5) to measure cognitive changes compared to a placebo group. The study will include individuals with elevated brain tau pathology but no clinical dementia symptoms. It is designed as a Phase 2 interventional trial to gather data on the drug's efficacy and safety.

Who should consider this trial

Good fit: Ideal candidates are individuals with elevated tau pathology but no clinical symptoms of dementia.

Not a fit: Patients with a history of Alzheimer's dementia or other forms of dementia will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could slow cognitive decline in individuals at risk for Alzheimer's disease.

How similar studies have performed: Other studies targeting early cognitive decline in Alzheimer's have shown promise, suggesting potential for this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Phoenix, Arizona and 74 other locations

+25 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Preclinical Alzheimer's Disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.