ISRCTN78730935 · Phase 2 · RECRUITING
A study of JNJ-64042056 in participants with preclinical Alzheimer's disease
This trial tests JNJ-64042056, a vaccine-like injection meant to help the body make antibodies against tau, a protein that builds up in Alzheimer's. About 4 years, compared with placebo, in people with no symptoms yet. The main measure is cognitive decline. It is a Phase 2 trial, testing whether it works and is safe, not yet proven or approved.
You may qualify if
- 55 to 75 years of age, inclusive, at randomisation visit.
- Elevated brain tau pathology defined as Braak 3 ROI SUVR > 1.1 on a screening tau PET scan, reviewed centrally by a qualified reader.
- CDR global score of 0 at screening and baseline.
- MMSE ≥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.
You're excluded if
- MRI evidence of any brain disease or intracranial pathology other than potential very early signs of AD or typical age-related changes, which in the opinion of the investigator or the central imaging reader and/or the sponsor, may affect cognition.
- History consistent with or known autosomal dominant AD.
- 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 ofMild Cognitive Impairment (MCI)
- Presence of any neurological, psychiatric, or medical conditions associated with a longterm risk of significant cognitive impairment or dementia
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2024-06-04
Source: ISRCTN registry, record ISRCTN78730935, retrieved 2026-10-27. Registry text licensed CC BY 4.0.