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AzTrials

Alzheimer's DiseasePhase 1NCT02360657

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

A Phase 1 study testing JNJ-54861911, 10 mg and JNJ-54861911, 50 mg in people with Alzheimer's Disease, run by Janssen Pharmaceutical K.K. at 2 sites in Japan.

Completed

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

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 to 85 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
JNJ-54861911, 10 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
18 participants
Where
2 sitesJapan
Study dates
16 Feb 2015to 8 Sep 2015
Phase
Phase 1
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 65 to 85 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

  • Study site

    Fukuoka

  • Study site

    Tokyo

Other trials in Japan

About this study

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

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.

Read the 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.

Being tested
JNJ-54861911, 10 mg, JNJ-54861911, 50 mg, Placebo
Keywords
Alzheimer's Disease, Alzheimer Dementia, JNJ-54861911, Beta Secretase Inhibitor
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 mgDrug

    JNJ-54861911, 10 mg (2*5 mg tablet) orally once daily for 4 weeks.

  • JNJ-54861911, 50 mgDrug

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

  • PlaceboDrug

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

Study groups in NCT02360657
Study groupRoleWhat they receive
JNJ-54861911, 10 mgExperimentalJNJ-54861911, 10 milligram (mg) (2*5 mg tablet) orally once daily for 4 weeks.
Receives: Drug: JNJ-54861911, 10 mg
JNJ-54861911, 50 mgExperimentalJNJ-54861911, 50 mg (2*25 mg tablet) orally once daily for 4 weeks.
Receives: Drug: JNJ-54861911, 50 mg
PlaceboPlacebo comparatorPlacebo matching to JNJ-54861911 tablet orally once daily for 4 weeks.
Receives: Drug: Placebo

What is being measured

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

  1. Levels of Amyloid (A)-beta1-40 in Cerebrospinal Fluid (CSF) After Treatment at the Intended Target Dose Range

    Measured: Up to 4 weeks

  2. Levels of A-beta1-40 in Plasma After Treatment at the Intended Target Dose Range

    Measured: Up to 4 weeks

  3. Maximum Observed Plasma Concentration (Cmax) of JNJ 54861911

    The Cmax is the maximum observed plasma concentration.

    Measured: Up to 4 weeks

  4. Minimum Observed Plasma Concentration (Cmin) of JNJ 54861911

    The Cmin is the minimum observed plasma concentration.

    Measured: Up to 4 weeks

  5. Time to Reach Maximum Observed Concentration (Tmax) of JNJ 54861911

    The Tmax is time to reach the maximum observed plasma concentration.

    Measured: Up to 4 weeks

  6. 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.

    Measured: Up to 4 weeks

  7. Cerebrospinal Fluid Exposure of JNJ-54861911

    Measured: 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

    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.

    Measured: Up to 4 weeks

Secondary outcomes (4)

  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

    Measured: 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

    Measured: 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

    Measured: Up to 4 weeks

  4. Compare the Relationship of A-beta1-40 Levels in Plasma and CSF After Treatment at the Intended Dose Range

    Measured: Up to 4 weeks

Timeline

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

  1. First posted10 Feb 2015 (estimated)
  2. Study start16 Feb 2015
  3. Primary completion8 Sep 2015
  4. Study completion8 Sep 2015

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02360657
Sponsor's protocol ID
CR106397
Other IDs
54861911ALZ1008
Status last verified
Jan 2019
First submitted
5 Feb 2015
Last updated
4 Feb 2019
Results posted
No
Data monitoring committee
No

Publications

  • Timmers M, Streffer JR, Russu A, Tominaga Y, Shimizu H, Shiraishi A, Tatikola K, Smekens P, Borjesson-Hanson A, Andreasen N, Matias-Guiu J, Baquero M, Boada M, Tesseur I, Tritsmans L, Van Nueten L, Engelborghs S. Pharmacodynamics of atabecestat (JNJ-54861911), an oral BACE1 inhibitor in patients with early Alzheimer's disease: randomized, double-blind, placebo-controlled study. Alzheimers Res Ther. 2018 Aug 23;10(1):85. doi: 10.1186/s13195-018-0415-6.

    PubMed 30134967

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JNJ-54861911, 10 mg and JNJ-54861911, 50 mg in people with Alzheimer's Disease, run by Janssen Pharmaceutical K.K. at 2 sites in Japan.

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 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Japan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Levels of Amyloid (A)-beta1-40 in Cerebrospinal Fluid (CSF) After Treatment at the Intended Target Dose Range (time frame: Up to 4 weeks). The study lists 8 primary outcomes in all. 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 NCT02360657, 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 4 Feb 2019.

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