Preclinical Alzheimer’s Disease Nervous System Diseases
Conditions
Interventions
Participants will be assigned by chance to one of two treatment groups: JNJ-64042056 or placebo. Participants will be assigned randomly by a central randomisation process.
Participants will receive t
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 55 to 75 years of age, inclusive, at randomisation visit. 2. Elevated brain tau pathology defined as Braak 3 ROI SUVR > 1.1 on a screening tau PET scan, reviewed centrally by a qualified reader. 3. CDR global score of 0 at screening and baseline. 4. MMSE =27 (with educational adjustment). 5. Able to read and write and with a minimum 5 years of formal education as reported by participant and study partner at screening.
Exclusion criteria
Exclusion criteria: 1. 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. 2. History consistent with or known autosomal dominant AD. 3. 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. 4. Diagnosis ofMild Cognitive Impairment (MCI) 5. Presence of any neurological, psychiatric, or medical conditions associated with a longterm risk of significant cognitive impairment or dementia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in Preclinical Alzheimer's Disease Cognitive Composite 5 (PACC-5) Total Scores up to Week 206 | — |
Secondary
| Measure | Time frame |
|---|---|
| Baseline up to Week 206 (unless noted otherwise): 1. Change From Baseline in Brain tau Burden as Measured by tau PET- Baseline and Weeks 102, 154 and 206 2. Change From Baseline in PACC-5 Individual Domain Scores 3. Time to Event of Clinical Progression as Measured by Clinical Dementia Rating-Global Score (CDR-GS) 4. Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Scores 5. Change from Baseline in Tau PET Standardized Uptake Value Ratio (SUVR) Biomarkers (tau Naiive Composite ROI and Other ROIs) 6. Change From Baseline in p217+tau 7. Change From Baseline in PACC-5 Total Score - Baseline up to Week 180 8. Change From Baseline in Brain Tau Burden as Measured by Tau PET in Other ROI 9. Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living -Prevention Instrument (ADCS-ADL-PI) 10. Change From Baseline in Mild Behavioral Impairment Checklist (MBI-C) Score 11. Change From Baseline in the Quality of Life- Alzheimer's Disease (QoL-AD) 12. Change From Baseline in European Quality of Life-5 Dimensions 5-Levels (EQ-5D-5L) Score 13. Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite) Score 14. Levels of IgG Titers Against Enriched Paired Helical Filaments (ePHF), p-tau and tau in Serum 15. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) - Up to Week 208 16. Number of Participants With Reactogenicity - Up to Week 182 17. Change from Baseline in Vital Signs 18. Change From Baseline in Clinical Laboratory Values 19. Change from Baseline in Electrocardiogram (ECG) Values 20. Change From Baseline in Columbia-Suicidality Severity Rating Scale (C-SSRS) 21. Change From Baseline in Magnetic Resonance Imaging (MRI) Findings | — |
Countries
Australia, Belgium, England, France, Germany, Japan, Netherlands, Scotland, Spain, Sweden, United Kingdom
Outcome results
None listed