The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of JNJ-54861911 in patients with prodromal Alzheimer's disease (pAD).
This will be a multicenter, double-blind (neither investigator nor patient knows which treatment the patient receives), placebo-controlled (placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), randomized (patients are assigned different treatments based on chance), multiple-dose, proof-of-mechanism (POM) study in pAD. Approximately 24 outpatients (n=8/treatment group) diagnosed with pAD, according to the inclusion and exclusion criteria, will participate in this 4-week treatment study. For all enrolled patients, this study will consist of an 8-week eligibility screening period, a 4-week double-blind treatment period, and a follow-up examination (7-14 days after the last dose). Patients will be assigned randomly to 1 of 3 treatment groups: placebo, JNJ-54861911 10 mg once daily, or JNJ-54861911 50 mg once daily. Safety assessments will be performed throughout the study. The maximal study duration for a patient will be 14 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
45
JNJ-54861911 10 mg will be administered as two 5 mg oral tablets once daily.
JNJ-54861911 50 mg will be administered as two 25 mg oral tablets once daily.
Matching placebo will be administered as 2 oral tablets once daily.
Unnamed facility
Antwerp, Belgium
Unnamed facility
Ghent, Belgium
Unnamed facility
Hoboken, Belgium
Unnamed facility
Amsterdam, Netherlands
Levels of amyloid beta 1-40 in cerebrospinal (CSF) after treatment at the intended target dose range
Time frame: Up to 4 weeks
Levels of amyloid beta 1-40 in plasma after treatment at the intended target dose range
Time frame: Up to 4 weeks
Maximum observed plasma concentration (Cmax) of JNJ-54861911
Cmax is the observed maximum plasma concentration of study drug, taken directly from the plasma concentration-time profile
Time frame: Up to 4 weeks
Time to reach maximum observed plasma concentration of JNJ-54861911
Time when Cmax is observed, taken directly from the plasma concentration-time profile
Time frame: Up to 4 weeks
Area under the plasma concentration time curve (AUC) from 0 to t hours of JNJ-54861911
Area under the plasma concentration-time curve from 0 to t hours post dosing (time t is the dosing interval)
Time frame: Up to 4 weeks
Half-life of JNJ-54861911
Elimination half-life associated with the terminal slope of the semi-logarithmic drug concentration-time curve, calculated as 0.693/terminal slope
Time frame: Up to 4 weeks
Cerebrospinal fluid exposure of JNJ-54861911
Time frame: Up to 4 weeks
The number of volunteers who experience adverse events as a measure of safety and tolerability of JNJ-54861911 after multiple-dose administration in the anticipated target dose range
Time frame: Up to 4 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Barcelona, Spain
Unnamed facility
Madrid, Spain
Unnamed facility
Terrassa, Spain
Unnamed facility
Valencia, Spain
Unnamed facility
Mölndal, Sweden
Unnamed facility
Stockholm, Sweden
Levels of amyloid beta fragments (amyloid beta 1-37, 1-38, and 1-42) in cerebrospinal fluid after treatment at the intended target dose range
Time frame: Up to 4 weeks
Levels of amyloid beta fragments (amyloid beta 1-37, 1-38, and 1-42) in plasma after treatment at the intended target dose range
Time frame: Up to 4 weeks
Levels of amyloid precursor protein (APP) fragments (soluble amyloid precursor protein α [sAPPalpha], sAPPbeta, totalAPP) in CSF after treatment at the intended target dose range
Time frame: Up to 4 weeks
Compare the relationship of amyloid beta 1-40 levels in plasma and cerebrospinal fluid after treatment at the intended target dose range
Time frame: Up to 4 weeks