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NCT Number: NCT06544616

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

55 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Neuro Trials Victoria, Carlton, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 possible new neurological signs or symptoms difficult

Treatment and study plan

JNJ-64042056

Drug

JNJ-64042056 will be administered intramuscularly.

Placebo

Drug

Placebo will be administered intramuscularly.

Primary outcomes

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

    Time frame: Baseline up to Week 102

    Change from baseline in brain tau burden, as measured by tau PET (including but not limited to Braak I-VI ROIs, tau naive composite ROI, Connection Rank ROI, and New Tau Composite ROI Volume) will be reported.

Secondary outcomes

  1. Levels of IgG Titers Against Enriched Paired Helical Filaments (ePHF), p-tau and tau in Serum

    Time frame: Up to Week 102

    Levels of IgG titers against ePHF, p-tau peptide and tau peptide in serum will be measured.

  2. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to Week 104

    An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the pharmaceutical or biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.

  3. Number of Participants With Reactogenicity

    Time frame: Up to Week 78

    Solicited AEs will be used to assess the reactogenicity of the active immunotherapy and are predefined local (at the injection site) and systemic events for which the participant is specifically questioned, and which are noted by participants in their participant diary.

  4. Number of Participants with Vital Signs Abnormalities

    Time frame: Up to Week 102

    Participants with vital signs abnormalities including temperature and blood pressure (systolic and diastolic) (supine) will be summarized over time.

  5. Number of Participants with Clinical Laboratory Abnormalities

    Time frame: Up to Week 102

    Participants with clinical laboratory abnormalities values (chemistry, hematology, urinalysis and coagulation) will be reported.

  6. Change from Baseline in Electrocardiogram (ECG) Values

    Time frame: Baseline up to Week 102

    Change from baseline in ECG values will be reported.

  7. Change From Baseline in Columbia-Suicidality Severity Rating Scale (C-SSRS)

    Time frame: Baseline up to Week 102

    A frequency distribution of C-SSRS scores at each scheduled time point by treatment will be provided. Shifts from the baseline visit to the most severe/maximum score during the treatment period will be summarized by treatment. The maximum score assigned for each participant will also be summarized into 1 of 3 categories: no suicidal ideation or behavior (0), suicidal ideation (1 to 5), suicidal behavior (6 to 10).

  8. Change From Baseline in Magnetic Resonance Imaging (MRI) Findings

    Time frame: Baseline up to Week 102

    Change from baseline in brain MRI safety findings will be reported.

Sponsors and collaborators

Lead sponsor

Janssen Pharmaceutica N.V., Belgium

Industry

Registry information

Official study title

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

Acronym: Reτain

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 9, 2024
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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