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    Summary
    EudraCT Number:2014-002159-24
    Sponsor's Protocol Code Number:54861911ALZ2002
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-10-07
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2014-002159-24
    A.3Full title of the trial
    A Phase 2a Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Multi-center Study Investigating the Safety and Tolerability of JNJ-54861911 in Subjects in the Early (Predementia) Alzheimer’s Disease Spectrum
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study in Subjects with Early Alzheimer’s Disease Investigating the Effects of JNJ-54861911 on Safety and Tolerability
    A.4.1Sponsor's protocol code number54861911ALZ2002
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen-Cilag International N.V.
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportJanssen Research and Development, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen Pharmaceutica N.V.
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number31071524 2166
    B.5.5Fax number31071524 2110
    B.5.6E-mailClinicalTrialsEU@its.jnj.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameJNJ-54861911
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1200493-78-2
    D.3.9.2Current sponsor codeJNJ-54861911
    D.3.9.3Other descriptive nameJNJ-54861911-AAA
    D.3.9.4EV Substance CodeSUB107735
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameJNJ-54861911
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1200493-78-2
    D.3.9.2Current sponsor codeJNJ-54861911
    D.3.9.3Other descriptive nameJNJ-54861911-AAA
    D.3.9.4EV Substance CodeSUB107735
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Early Alzheimer's Disease
    E.1.1.1Medical condition in easily understood language
    Alzheimer's Disease (AD) is a neurodegenerative disease associated with aging. AD patients suffer from cognition deficits and memory loss as well as behavioral problems such as anxiety.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10074616
    E.1.2Term Prodromal Alzheimer's disease
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to investigate the longer-term safety and tolerability of JNJ-54861911 during 6 months of treatment in subjects in the early (predementia) AD spectrum.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    • To assess the relationship of dose and exposure of JNJ-54861911 with safety in subjects in the early AD spectrum.
    • To evaluate the pharmacokinetics over time of JNJ-54861911 in subjects in the early AD spectrum.
    • To assess changes in CSF Aβ species (Aβ1-37, Aβ1-38, Aβ1-40, Aβ1-42) and soluble amyloid precursor protein (sAPP) fragments (sAPPα, sAPPβ, total sAPP) at 6 months of treatment with JNJ-54861911 compared to placebo in subjects in the early AD spectrum.
    • To assess changes in plasma Aβ1-40 and sAPP fragments (sAPPα, sAPPβ, total sAPP) at 6 months of treatment with JNJ-54861911 compared to placebo in subjects in the early AD spectrum.
    • To assess the relationship of changes in CSF and plasma Aβ species and sAPP fragments with safety in subjects in the early AD spectrum.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Each potential subject must satisfy all of the following criteria to be enrolled in the study.
    1. Subjects in the early AD spectrum must have a global CDR score of 0 (asymptomatic at risk for AD) to 0.5 (pAD) inclusive
    2. Subjects with pAD: Subject must be a man or woman between 50 and 85 years of age, inclusive.
    Subjects who are asymptomatic at risk for AD: Subject must be a man or woman between 65 and 85 years of age, inclusive. If rolling over from study 54861911ALZ1005 subjects aged 60 to 64 maybe included.
    3. Subjects must have had sufficient education or work experience to exclude mental retardation and must be able to read and write.
    4. Subjects must have evidence of amyloid pathology by means of either:
    a) low CSF Aß1-42 levels at screening
    b) a positive amyloid PET scan at screening (depending on the site’s PET capability) by visual read
    5. Subjects must have a body mass index (BMI=weight/height²) between 18 and 35 kg/m2, inclusive, at screening.
    6. Before randomization, a woman must be not of childbearing potential: postmenopausal (≥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 subject.
    7. A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control e.g., either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug. In addition, their female partners, if of childbearing potential, should also use an appropriate method of birth control for at least the same duration. Effective methods of contraception include prescription oral contraceptives, contraceptive injections, intrauterine device, double barrier method, contraceptive patch.
    8. Subjects 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.
    9. Subjects must be otherwise healthy or medically stable on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel [including liver enzymes, other specific tests], hematology, or urinalysis are outside the normal reference ranges, the subject may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant, to be appropriate and reasonable for the population under study and not to be a potential cause of cognitive impairment, with written concurrence with the sponsor's medical monitor. This determination must be recorded in the subject’s source documents and initialed by the investigator.
    10. Subjects must have a reliable informant (relative, partner, or friend). The informant must be willing to participate as a source of information and has at least weekly contact with the subject (contact can be in-person, via telephone or electronic communication). The informant must have sufficient contact such that the investigator feels he/she can provide meaningful information about the subject’s daily function.
    11. Subject must be able to be compliant with self-administration of medication
    12. Subject must be able to swallow drug as a whole.
    13. Subject must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
    14. Subject must sign an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
    E.4Principal exclusion criteria
    Any potential subject who meets any of the following criteria will be excluded from participating in the study.
    1. Subject has evidence of any brain disease, other than potential very early signs of AD or typical age-related changes or any other abnormality that could explain a possible cognitive deficit.
    2. Subject has met criteria for dementia or has a degenerative brain disorder that can cause dementia.
    3. Subject has evidence of familial autosomal dominant AD.
    4. Subject has a history of or current thyroid disease, thyroid dysfunction and is currently untreated for it.
    5. Subject has a vitamin B12 or folic acid deficiency.
    6. History or presence of significant depression as defined by the most current DSM criteria.
    7. Subject has chromosome 21 trisomy (Down Syndrome);
    8. Subject has a history of or current evidence of neurosyphilis
    9. Subject has any contra-indications for MRI.
    10. Subject has a clinically significant abnormal physical- or neurological examination, vital signs at screening or baseline.
    11. Subject has, in the opinion of the investigator, a clinically significant 12-lead ECG at screening or baseline. In case of triplicate ECG recordings, 2 out of 3 individual recordings must have a QTc below 450 msec
    12. Subject has a relevant history of or current neurological disease which in the opinion of the investigator may make interpretation of possible new neurological signs or symptoms difficult.
    13. Subject has a history of or current liver or renal insufficiency; clinically significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, hematologic, rheumatologic, psychiatric, or metabolic disturbances.
    14. Subject has a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator is considered cured with minimal risk of recurrence).
    15. Subject has a history of epilepsy or fits or unexplained black-outs other than vasovagal collapse within 10 years before screening.
    16. Subject has current anemia.
    17. Subject has a history of positive tests for hepatitis B surface antigen or hepatitis C antibody, or other clinically active liver disease.
    18. Subject has a history of human immunodeficiency virus (HIV) antibody positive.
    19. Subject has a history of drug or alcohol abuse according to most current DSM criteria within 6 months before Screening or positive test result(s) for alcohol or other drugs of abuse at Screening (except if related to current treatment e.g., benzodiazepines).
    20. Subject has taken any disallowed therapies.
    21. Subject has a clinically significant acute illness within 7 days prior to study drug administration.
    22. Subject has known allergies, hypersensitivity, or intolerance to JNJ-54861911 or its excipients.
    23. Subject has received an investigational drug (excluding the use of JNJ-54861911 in previous studies).
    24. Subject is a man who plans to father a child while enrolled in this study or within 3 months after the last dose of study drug.
    25. Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject or that could prevent, limit, or confound the protocol-specified assessments.
    26. Subject has had major surgery, (e.g., requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the subject is expected to participate in the study or within 4 weeks after the last dose of study drug administration.
    27. Subject has a history of spontaneous, prolonged or severe bleeding.
    28. Subject has donated one or more units of blood or acute loss of an equivalent amount of blood within 90 days prior to study drug administration.
    29. Subject has a topical infection or local dermatological condition at the puncture site prior to puncture that may compromise the lumbar puncture.
    30. Subject has a pigmentation abnormality of the skin such as vitiligo.
    31. Subject has signs of increased intracranial pressure.
    32. Subject has a current or recent history of clinically significant suicidal ideation within the past 6 months, or a history of suicidal behavior within the past year.
    33. Subject is an employee of the investigator or study site, as well as family members of the employees or the investigator.
    34. Subject has any condition that would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements.
    35. Only for subjects who will have an optional PET scan performed at screening: Subject has past or planned exposure to ionizing radiation that in combination with the planned administration with study amyloid PET ligand would result in a cumulative exposure that exceeds local recommended exposure limits.
    36. Subject is unable to comply with the study-specific requirements.
    E.5 End points
    E.5.1Primary end point(s)
    The assessment of specified safety parameters of JNJ-54861911
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    E.5.2Secondary end point(s)
    The assessment of specified pharmacokinetic parameters of JNJ-54861911
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 99
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-10-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-26
    P. End of Trial
    P.End of Trial StatusCompleted
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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