AzTrials
AzTrials

Alzheimer's DiseasePhase 2NCT02260674

A Safety and Tolerability Study of JNJ-54861911 in Participants With Early Alzheimer's Disease

A Phase 2 study testing JNJ-54861911, 10 milligram (mg) and JNJ-54861911, 50 mg in people with Alzheimer's Disease, run by Janssen Research & Development, LLC at 19 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the long-term safety and tolerability of JNJ-54861911 during 6 months of treatment in participants with early (predementia) alzheimer's disease (AD [degenerative disease of the brain characterized by the insidious onset of dementia, impairment of memory, judgment, attention… Read more about this study

Who is it for?
Ages 50 to 85 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
JNJ-54861911, 10 milligram (mg) and JNJ-54861911, 50 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
114 participants
Where
19 sitesin 6 countries
Study dates
Nov 2014to Jun 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

19 sites in 6 countries.

19 sites in 6 countries

Germany7 sites

  • Study site

    Essen

  • Study site

    Halle

  • Study site

    Hamburg

  • Study site

    Homburg

  • Study site

    Lübeck

  • Study site

    Tübingen

  • Study site

    Ulm

Other trials in Germany

Spain4 sites

  • Study site

    Barcelona

  • Study site

    Madrid

  • Study site

    Terrasa Barcelona N/A

  • Study site

    Valencia

Other trials in Spain

France3 sites

  • Study site

    Montpellier

  • Study site

    Paris

  • Study site

    Toulouse

Other trials in France

Belgium2 sites

  • Study site

    Ghent

  • Study site

    Hoboken

Other trials in Belgium

Sweden2 sites

  • Study site

    Mölndal

  • Study site

    Stockholm

Other trials in Sweden

Netherlands1 site

  • Study site

    Amsterdam

Other trials in Netherlands

About this study

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

The purpose of this study is to evaluate the long-term safety and tolerability of JNJ-54861911 during 6 months of treatment in participants with early (predementia) alzheimer's disease (AD [degenerative disease of the brain characterized by the insidious onset of dementia, impairment of memory, judgment, attention span, and problem solving skills are followed by severe apraxias and a global loss of cognitive abilities]).

Read the detailed description

This is a double-blind (neither the researchers nor the participants know what treatment the participant is receiving), placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect), randomized (study drug assigned by chance), multi-center (when more than one hospital or medical school team work on a medical research study), parallel-group study. The study consists of 3 Parts; Screening Phase of 90 days, double-blind Treatment Phase of 6 months and Follow-up Phase of 7 to 28 days following the last dose in Month 6. Eligible participants in the early (predementia) AD spectrum will be randomized to either Treatment group 1, 2 or placebo and participants who previously participated in study 54861911ALZ1005 will be enrolled in this study and will receive the same treatment as in study 54861911ALZ1005. The study duration for each participant will be approximately 10 months. Blood and cerebrospinal fluid (CSF) samples will be collected to evaluate the plasma pharmacokinetics of JNJ-54861911, as well as amyloid beta fragments. Participants' safety will be monitored throughout the study, including magnetic resonance imaging (MRI) and cognitive measures.

Being tested
JNJ-54861911, 10 milligram (mg), JNJ-54861911, 50 mg, Placebo
Keywords
Alzheimer's Disease, JNJ-54861911, Placebo
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ-54861911, 10 milligram (mg)Drug

    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.

  • JNJ-54861911, 50 mgDrug

    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.

  • PlaceboDrug

    Placebo matched to JNJ-54861911, orally, once daily, from Day 1 until Month 6 in placebo group.

Study groups in NCT02260674
Study groupRoleWhat they receive
Treatment Group 1ExperimentalParticipants 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.
Receives: Drug: JNJ-54861911, 10 milligram (mg)
Treatment Group 2ExperimentalParticipants 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.
Receives: Drug: JNJ-54861911, 50 mg
PlaceboPlacebo comparatorPlacebo matched to JNJ-54861911, orally, once daily, from Day 1 until Month 6.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)

    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.

    Measured: up to 10 months

Secondary outcomes (7)

  1. Relationship Between Dose and Exposure of JNJ-54861911 With Safety

    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.

    Measured: Month 1 up to Month 6

  2. 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

    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.

    Measured: Baseline and Month 6

  3. Percent Change From Baseline in Plasma ABeta 1-40 Levels and sAPP Fragments (sAPP-alpha, sAPP-beta), Total sAPP Levels

    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.

    Measured: Baseline and Month 6 (Day 168)

  4. Relationship Between Changes in CSF and Plasma ABeta Species and sAPP Fragments With Safety

    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.

    Measured: Month 1 up to Month 6

  5. Maximum Plasma Concentration (Cmax) of JNJ-54861911

    The Cmax is the maximum observed plasma concentration.

    Measured: Pre-dose on Day 1, post-dose on Day 28, 56, 84, 112, 140 and 168

  6. Time to Reach the Maximum Plasma or CSF concentration (Tmax)

    The Tmax is the time to reach the maximum plasma or CSF concentration.

    Measured: Pre-dose on Day 1, post-dose on Day 28, 56, 84, 112, 140 and 168

  7. Area Under the Plasma/CSF Concentration-time Curve From Time 0 to tau Hours Post Dosing (AUCtau)

    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.

    Measured: Pre-dose on Day 1, post-dose on Day 28, 56, 84, 112, 140 and 168

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionJun 2016
  4. Study completionJun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02260674
Sponsor's protocol ID
CR105240
Other IDs
54861911ALZ2002, 2014-002159-24, 2014
Status last verified
Apr 2025
First submitted
6 Oct 2014
Last updated
29 Apr 2025
Results posted
No
Data monitoring committee
Yes

Publications

  • Novak G, Streffer JR, Timmers M, Henley D, Brashear HR, Bogert J, Russu A, Janssens L, Tesseur I, Tritsmans L, Van Nueten L, Engelborghs S. Long-term safety and tolerability of atabecestat (JNJ-54861911), an oral BACE1 inhibitor, in early Alzheimer's disease spectrum patients: a randomized, double-blind, placebo-controlled study and a two-period extension study. Alzheimers Res Ther. 2020 May 14;12(1):58. doi: 10.1186/s13195-020-00614-5.

    PubMed 32410694

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JNJ-54861911, 10 milligram (mg) and JNJ-54861911, 50 mg in people with Alzheimer's Disease, run by Janssen Research & Development, LLC at 19 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Germany, Spain, France, Belgium, Sweden and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) (time frame: up to 10 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02260674, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in