The purpose of this study is to determine the safety, tolerability and effect of JNJ-54861911 on level of amyloid-beta in Cerebrospinal Fluid (CSF) and plasma following 4 weeks of treatment in Japanese participants asymptomatic at risk for Alzheimer Dementia (ARAD) at the intended target dose range.
This is a multi-center (when more than one hospital or medical school team work on a medical research study), double-blind (neither physician nor participant knows the treatment that the participant receives), placebo-controlled (the experimental treatment or procedure is compared to an inactive substance), randomized (study medication assigned by chance), multiple dose, Proof of Mechanism (POM) study in Japanese participants ARAD. All eligible participants will be randomly assigned to 1 of 3 treatment groups (that is, placebo, JNJ-54861911 10 milligram \[mg\] or JNJ-54861911 50 mg once daily regimen). This study will consist of Screening Phase (8-week), Double blind Treatment Phase (4-week), and Follow-up Phase (2-week). The maximum study duration for a participant will be 14 weeks. Participant's safety will be monitored throughout the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
18
JNJ-54861911, 10 mg (2\*5 mg tablet) orally once daily for 4 weeks.
JNJ-54861911, 50 mg (2\*25 mg tablet) orally once daily for 4 weeks.
Placebo matching to JNJ-54861911 tablet orally once daily for 4 weeks.
Unnamed facility
Fukuoka, Japan
Unnamed facility
Tokyo, Japan
Levels of Amyloid (A)-beta1-40 in Cerebrospinal Fluid (CSF) After Treatment at the Intended Target Dose Range
Time frame: Up to 4 weeks
Levels of A-beta1-40 in Plasma After Treatment at the Intended Target Dose Range
Time frame: Up to 4 weeks
Maximum Observed Plasma Concentration (Cmax) of JNJ 54861911
The Cmax is the maximum observed plasma concentration.
Time frame: Up to 4 weeks
Minimum Observed Plasma Concentration (Cmin) of JNJ 54861911
The Cmin is the minimum observed plasma concentration.
Time frame: Up to 4 weeks
Time to Reach Maximum Observed Concentration (Tmax) of JNJ 54861911
The Tmax is time to reach the maximum observed plasma concentration.
Time frame: Up to 4 weeks
Area Under the Curve From Time Zero to end of Dosing Interval (AUCtau)
The AUCtau is a measure of the plasma drug concentration from time zero to end of dosing interval. It is used to characterize drug absorption.
Time frame: Up to 4 weeks
Cerebrospinal Fluid Exposure of JNJ-54861911
Time frame: Up to 4 weeks
The Number of Participants who Experienced Adverse Events as a Measure of Safety and Tolerability of JNJ-54861911 After Multiple-Dose Administration in the Anticipated Target Dose Range
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
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Time frame: Up to 4 weeks
Levels of A-beta Fragments (A-beta1-37, A-beta1-38, and A-beta1-42) in CSF After Treatment at the Intended Target Dose Range
Time frame: Up to 4 weeks
Levels of A-beta Fragments (A-beta1-37, A-beta1-38, and A-beta1-42) in Plasma After Treatment at the Intended Target Dose Range
Time frame: Up to 4 weeks
Levels of Soluble Amyloid Precursor Protein (APP) Fragments in CSF (sAPP-alpha, sAPP-beta, totalAPP) After Treatment at the Intended Target Dose Range
Time frame: Up to 4 weeks
Compare the Relationship of A-beta1-40 Levels in Plasma and CSF After Treatment at the Intended Dose Range
Time frame: Up to 4 weeks