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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
55
JNJ-64042056 will be administered intramuscularly.
Placebo will be administered intramuscularly.
Change From Baseline in Brain Tau Burden as Measured by Tau PET in Specified Regions of Interest (ROI)
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.
Time frame: Baseline up to Week 102
Levels of IgG Titers Against Enriched Paired Helical Filaments (ePHF), p-tau and tau in Serum
Levels of IgG titers against ePHF, p-tau peptide and tau peptide in serum will be measured.
Time frame: Up to Week 102
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
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.
Time frame: Up to Week 104
Number of Participants With Reactogenicity
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.
Time frame: Up to Week 78
Number of Participants with Vital Signs Abnormalities
Participants with vital signs abnormalities including temperature and blood pressure (systolic and diastolic) (supine) will be summarized over time.
Time frame: Up to Week 102
Number of Participants with Clinical Laboratory Abnormalities
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Xenoscience Inc.
Phoenix, Arizona, United States
Irvine Clinical Research
Irvine, California, United States
Esperanza Clinical
Murrieta, California, United States
Artemis Institute for Clinical Research Riverside
Riverside, California, United States
Artemis Institute for Clinical Research San Diego
San Diego, California, United States
Yale University School Of Medicine
New Haven, Connecticut, United States
JEM Research LLC
Atlantis, Florida, United States
Excel Medical Clinical Trials, LLC
Boca Raton, Florida, United States
K2 Medical Research Winter Garden
Clermont, Florida, United States
Clinical NeuroScience Solutions Inc
Jacksonville, Florida, United States
...and 80 more locations
Participants with clinical laboratory abnormalities values (chemistry, hematology, urinalysis and coagulation) will be reported.
Time frame: Up to Week 102
Change from Baseline in Electrocardiogram (ECG) Values
Change from baseline in ECG values will be reported.
Time frame: Baseline up to Week 102
Change From Baseline in Columbia-Suicidality Severity Rating Scale (C-SSRS)
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).
Time frame: Baseline up to Week 102
Change From Baseline in Magnetic Resonance Imaging (MRI) Findings
Change from baseline in brain MRI safety findings will be reported.
Time frame: Baseline up to Week 102