Alzheimer Disease
Conditions
Brief 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.
Interventions
DRUGJNJ-64042056
JNJ-64042056 will be administered intramuscularly.
DRUGPlacebo
Placebo will be administered intramuscularly.
Sponsors
Janssen Pharmaceutica N.V., Belgium
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
55 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Brain Tau Burden as Measured by Tau PET in Specified Regions of Interest (ROI) | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Reactogenicity | 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. |
| Number of Participants with Vital Signs Abnormalities | Up to Week 102 | Participants with vital signs abnormalities including temperature and blood pressure (systolic and diastolic) (supine) will be summarized over time. |
| Number of Participants with Clinical Laboratory Abnormalities | Up to Week 102 | Participants with clinical laboratory abnormalities values (chemistry, hematology, urinalysis and coagulation) will be reported. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 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. |
| Change From Baseline in Columbia-Suicidality Severity Rating Scale (C-SSRS) | 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). |
| Change From Baseline in Magnetic Resonance Imaging (MRI) Findings | Baseline up to Week 102 | Change from baseline in brain MRI safety findings will be reported. |
| Levels of IgG Titers Against Enriched Paired Helical Filaments (ePHF), p-tau and tau in Serum | Up to Week 102 | Levels of IgG titers against ePHF, p-tau peptide and tau peptide in serum will be measured. |
| Change from Baseline in Electrocardiogram (ECG) Values | Baseline up to Week 102 | Change from baseline in ECG values will be reported. |
Countries
Australia, Belgium, France, Germany, Japan, Spain, Sweden, United Kingdom, United States
Contacts
STUDY_DIRECTORJanssen Pharmaceutica N.V., Belgium Clinical trial
Janssen Pharmaceutica N.V., Belgium
Outcome results
None listed