A Safety and Tolerability Study of JNJ-54861911 in Participants With Early Alzheimer's Disease
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02260674 |
Recruitment Status :
Completed
First Posted : October 9, 2014
Last Update Posted : March 3, 2017
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Condition or disease | Intervention/treatment | Phase |
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Alzheimer's Disease | Drug: JNJ-54861911, 10 milligram (mg) Drug: JNJ-54861911, 50 mg Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 114 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Care Provider) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2a Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Multi-center Study Investigating the Safety and Tolerability of JNJ-54861911 in Subjects With Early Alzheimer's Disease |
Study Start Date : | November 2014 |
Actual Primary Completion Date : | June 2016 |
Actual Study Completion Date : | June 2016 |

Arm | Intervention/treatment |
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Experimental: Treatment Group 1
Participants will self-administer JNJ-54861911, two tablets of 5 milligram (mg) each for a total of 10 mg, orally, once daily, from Day 1 until Month 6.
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Drug: JNJ-54861911, 10 milligram (mg)
Participants will self-administer JNJ-54861911, two tablets of 5 mg each for a total of 10 mg, orally, once daily, from Day 1 until Month 6 in treatment group 1. |
Experimental: Treatment Group 2
Participants will self-administer JNJ-54861911, two tablets of 25 mg each for a total of 50 mg, orally, once daily, from Day 1 until Month 6.
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Drug: JNJ-54861911, 50 mg
Participants will self-administer JNJ-54861911, two tablets of 25 mg each for a total of 50 mg, orally, once daily, from Day 1 until Month 6 in treatment group 2. |
Placebo Comparator: Placebo
Placebo matched to JNJ-54861911, orally, once daily, from Day 1 until Month 6.
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Drug: Placebo
Placebo matched to JNJ-54861911, orally, once daily, from Day 1 until Month 6 in placebo group. |
- Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: up to 10 months ]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; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
- Relationship Between Dose and Exposure of JNJ-54861911 With Safety [ Time Frame: Month 1 up to Month 6 ]Plasma and, if possible, CSF measurements will be taken to measure the concentration of JNJ-54861911. Population pharmacokinetic modeling (statistical modeling) will be used to derive individual pharmacokinetic parameters (e.g. Cmax, AUCtau, Tmax) in plasma and, if possible, in CSF. Incidence of adverse events and their timing of onset will be examined with regard to these concentrations to assess potential relationships between safety and exposure.
- Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid Beta (ABeta) (1-37, 1-38, 1-40, 1-42) Levels and Soluble Amyloid Precursor Protein (sAPP) Fragments (sAPP-alpha, sAPP-beta), Total sAPP Levels [ Time Frame: Baseline and Month 6 ]The CSF samples will be obtained for measuring levels of different ABeta fragments such as ABeta 1-37, ABeta 1-38, ABeta 1-40, ABeta 1-42. ABeta fragments of different length are produced by cleavage of the APP by beta-secretase (BACE) and the gamma-secretase complex in the brain and excreted into CSF. For participants, who participated previously in study 54861911ALZ1005, the baseline CSF sample taken during that study may be used as baseline in this study.
- Percent Change From Baseline in Plasma ABeta 1-40 Levels and sAPP Fragments (sAPP-alpha, sAPP-beta), Total sAPP Levels [ Time Frame: Baseline and Month 6 (Day 168) ]Plasma samples will be obtained for measuring levels of different ABeta fragments such as ABeta 1-37, ABeta 1-38, ABeta 1-40, ABeta 1-42. ABeta fragments of different length are produced by cleavage of the APP by beta-secretase (BACE) and the gamma-secretase complex in the different peripheral tissues, including white blood cells and can be measured in Plasma.
- Relationship Between Changes in CSF and Plasma ABeta Species and sAPP Fragments With Safety [ Time Frame: Month 1 up to Month 6 ]ABeta species and sAPP fragments in plasma and CSF will be measured. Incidence of adverse events and their timing of onset will be examined with regard to these concentrations to assess potential relationships between safety and changes in the ABeta species and sAPP fragments.
- Maximum Plasma Concentration (Cmax) of JNJ-54861911 [ Time Frame: Pre-dose on Day 1, post-dose on Day 28, 56, 84, 112, 140 and 168 ]The Cmax is the maximum observed plasma concentration.
- Time to Reach the Maximum Plasma or CSF concentration (Tmax) [ Time Frame: Pre-dose on Day 1, post-dose on Day 28, 56, 84, 112, 140 and 168 ]The Tmax is the time to reach the maximum plasma or CSF concentration.
- Area Under the Plasma/CSF Concentration-time Curve From Time 0 to tau Hours Post Dosing (AUCtau) [ Time Frame: Pre-dose on Day 1, post-dose on Day 28, 56, 84, 112, 140 and 168 ]AUCtau is the area under the plasma/CSF concentration-time curve from time 0 to tau hours post dosing. Time tau is the dosing interval.

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Ages Eligible for Study: | 50 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Participants in the early alzheimer's disease (AD) spectrum must have a global Clinical Dementia Rating Scale( CDR) score of 0 (asymptomatic at risk for AD) to 0.5 prodromal AD (pAD) inclusive
- Participants must have evidence of amyloid pathology by means of either: a) low Cerebrospinal Fluid (CSF) ABeta 1-42 levels at screening; b) a positive amyloid positron emission tomography (PET) scan at screening (depending on the site's PET capability) by visual read
- Participants must have a body mass index between 18 and 35 kilogram per square meter (kg/m^2), inclusive, at screening
- Participants 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 ECG performed at screening or at baseline. If there are abnormalities, they must be consistent with the underlying illness in the study population and not a potential cause of cognitive impairment, with written concurrence with the sponsor's medical monitor
- Before randomization, a woman must be not of childbearing potential: postmenopausal (greater than or equal to [>=] 50 years of age with amenorrhea for at least 12 months; permanently sterilized [e.g., tubal occlusion, hysterectomy, bilateral salpingectomy]); or otherwise be incapable of pregnancy. In case of questionable status qualified personal of the sponsor should be consulted to decide on the potential for inclusion of the participant
Exclusion Criteria:
- Participant has evidence of any brain disease, other than potential very early signs of AD (e.g. mild hippocampal atrophy) or typical age-related changes (e.g. mild white matter hyperintensity on magnetic resonance imaging [MRI]) or any other abnormality (e.g. folic acid/Vitamin B12 deficiency) that could explain a possible cognitive deficit (including, but not limited to vascular encephalopathy or strokes including lacuna's (as imaged by cerebral MRI) and Major Depression (as defined by most current Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria)
- Participant has evidence of familial autosomal dominant AD. (Inclusion can be made upon written confirmation by sponsor, when the mutation is known and deemed not to be modulating Beta-secretase [BACE] cleavage)
- Participant with history or presence of significant depression as defined by the most current DSM criteria
- Participant has a clinically significant abnormal physical- or neurological examination, vital signs at screening or baseline (Day 1 predose)
- Participant has a history of or current liver or renal insufficiency; clinically significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, hematologic, rheumatologic, psychiatric, or metabolic disturbances (e.g. unstable situation needing monitoring or regular dose adaptations)

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): NCT02260674
Belgium | |
Gent, Belgium | |
Hoboken, Belgium | |
France | |
Montpellier Cedex 5, France | |
Paris, France | |
Toulouse, France | |
Germany | |
Essen, Germany | |
Halle, Germany | |
Hamburg N/A, Germany | |
Homburg, Germany | |
Luebeck, Germany | |
Tübingen, Germany | |
Ulm, Germany | |
Netherlands | |
Amsterdam, Netherlands | |
Spain | |
Barcelona, Spain | |
Madrid, Spain | |
Terrasa Barcelona N/A, Spain | |
Valencia, Spain | |
Sweden | |
Mölndal, Sweden | |
Stockholm, Sweden |
Study Director: | Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC |
Responsible Party: | Janssen Research & Development, LLC |
ClinicalTrials.gov Identifier: | NCT02260674 |
Other Study ID Numbers: |
CR105240 54861911ALZ2002 ( Other Identifier: Janssen Research & Development, LLC ) 2014-002159-24 ( EudraCT Number ) |
First Posted: | October 9, 2014 Key Record Dates |
Last Update Posted: | March 3, 2017 |
Last Verified: | March 2017 |
Alzheimer's Disease JNJ-54861911 Placebo |
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |