JNJ-54861911, 10 mg
DrugJNJ-54861911, 10 mg (2*5 mg tablet) orally once daily for 4 weeks.
NCT Number: NCT02360657
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.
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Notify Me65 year–85 year
All sexes
Interventional
Phase 1
Fukuoka, Japan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Up to 4 weeks
Time frame: Up to 4 weeks
Time frame: Up to 4 weeks
The Cmax is the maximum observed plasma concentration.
Time frame: Up to 4 weeks
The Cmin is the minimum observed plasma concentration.
Time frame: Up to 4 weeks
The Tmax is time to reach the maximum observed plasma concentration.
Time frame: Up to 4 weeks
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
Time frame: Up to 4 weeks
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.
Time frame: Up to 4 weeks
Time frame: Up to 4 weeks
Time frame: Up to 4 weeks
Time frame: Up to 4 weeks
Janssen Pharmaceutical K.K.
Industry
A Double-blind, Placebo-controlled, Randomized, 4-Week, Multiple-dose, Proof of Mechanism (POM) Study in Japanese Subjects Asymptomatic at Risk for Alzheimer Dementia (ARAD) Investigating the Effects of JNJ-54861911 on A-beta Processing in Cerebrospinal Fluid (CSF) and Plasma
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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