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Study Investigating the Effects of JNJ-54861911 on Amyloid-beta Processing in Cerebrospinal Fluid (CSF) and Plasma in Japanese Participants Asymptomatic at Risk for Alzheimer Dementia

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ClinicalTrials.gov Identifier: NCT02360657
Recruitment Status : Completed
First Posted : February 10, 2015
Last Update Posted : January 25, 2016
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: JNJ-54861911, 10 mg Drug: JNJ-54861911, 50 mg Drug: Placebo Phase 1

Detailed Description:
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  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015


Arm Intervention/treatment
Experimental: JNJ-54861911, 10 mg
JNJ-54861911, 10 milligram (mg) (2*5 mg tablet) orally once daily for 4 weeks.
Drug: JNJ-54861911, 10 mg
JNJ-54861911, 10 mg (2*5 mg tablet) orally once daily for 4 weeks.

Experimental: JNJ-54861911, 50 mg
JNJ-54861911, 50 mg (2*25 mg tablet) orally once daily for 4 weeks.
Drug: JNJ-54861911, 50 mg
JNJ-54861911, 50 mg (2*25 mg tablet) orally once daily for 4 weeks.

Placebo Comparator: Placebo
Placebo matching to JNJ-54861911 tablet orally once daily for 4 weeks.
Drug: Placebo
Placebo matching to JNJ-54861911 tablet orally once daily for 4 weeks.




Primary Outcome Measures :
  1. Levels of Amyloid (A)-beta1-40 in Cerebrospinal Fluid (CSF) After Treatment at the Intended Target Dose Range [ Time Frame: Up to 4 weeks ]
  2. Levels of A-beta1-40 in Plasma After Treatment at the Intended Target Dose Range [ Time Frame: Up to 4 weeks ]
  3. Maximum Observed Plasma Concentration (Cmax) of JNJ 54861911 [ Time Frame: Up to 4 weeks ]
    The Cmax is the maximum observed plasma concentration.

  4. Minimum Observed Plasma Concentration (Cmin) of JNJ 54861911 [ Time Frame: Up to 4 weeks ]
    The Cmin is the minimum observed plasma concentration.

  5. Time to Reach Maximum Observed Concentration (Tmax) of JNJ 54861911 [ Time Frame: Up to 4 weeks ]
    The Tmax is time to reach the maximum observed plasma concentration.

  6. Area Under the Curve From Time Zero to end of Dosing Interval (AUCtau) [ 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.

  7. Cerebrospinal Fluid Exposure of JNJ-54861911 [ Time Frame: Up to 4 weeks ]
  8. 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 [ 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.


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]


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Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant must have had sufficient education or work experience to exclude mental retardation based on Diagnostic and Statistical Manual of Mental Disorders 4th edition, Text Revision (DSM-IV-TR) and must be able to read and write and must have adequate hearing and visual acuity to complete the required psychometric tests
  • Participant must have a Clinical Dementia Rating Scale- Japanese version (CDR-J) score of '0' and as such rated as normal
  • Participant must have evidence of amyloid deposition as demonstrated by low Cerebrospinal Fluid (CSF) Amyloid (A)-beta 1-42 levels at Screening
  • Participant must have a body mass index between 18 and 35 kilogram per square meter, inclusive, at Screening
  • Participant must be otherwise healthy for their age group or medically stable with or without medication on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at Screening or at Baseline

Exclusion Criteria:

  • Participant has evidence of any brain disease other than potential very early signs of Alzheimer's disease (AD) or typical age related changes, or any other abnormality that could explain a possible cognitive deficit
  • Participant has been diagnosed with dementia due to AD, due to other diseases, or with AD and contribution of other disorders (mixed dementia)
  • Participant has evidence of familial autosomal dominant AD
  • Participant has any contra-indications for Magnetic Resonance Imaging (MRI) (for example, prostheses, implants, claustrophobia, pacemakers, and others)
  • Participant has a clinically significant abnormal physical- or neurological examination, vital signs or 12-lead ECG (including QTc greater than 450 millisecond for males and females, left bundle branch block, atrio-ventricular [AV] block second degree or higher, permanent pacemaker or implantable cardioverter defibrillator [ICD]) at Screening or Baseline, which in the opinion of the investigator is not appropriate and reasonable for the population under study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02360657


Locations
Japan
Fukuoka, Japan
Tokyo, Japan
Sponsors and Collaborators
Janssen Pharmaceutical K.K.
Investigators
Study Director: Janssen Pharmaceutical K.K., Japan Clinical Trial Janssen Pharmaceutical K.K.

Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT02360657     History of Changes
Other Study ID Numbers: CR106397
54861911ALZ1008 ( Other Identifier: Janssen Pharmaceutical K.K., Japan )
First Posted: February 10, 2015    Key Record Dates
Last Update Posted: January 25, 2016
Last Verified: January 2016

Keywords provided by Janssen Pharmaceutical K.K.:
Alzheimer's Disease
Alzheimer Dementia
JNJ-54861911
Beta Secretase Inhibitor

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders