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    Summary
    EudraCT Number:2018-004149-17
    Sponsor's Protocol Code Number:40346527ALZ1001
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-04-24
    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 ConcernedUK - MHRA
    A.2EudraCT number2018-004149-17
    A.3Full title of the trial
    A randomised, placebo-controlled, single-blind study to characterise the biomarker effects of the CSF-1 receptor antagonist JNJ-40346527 in participants with mild cognitive impairment
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomised, placebo-controlled, single-blind study to characterise the biomarker effects of the CSF-1 receptor antagonist JNJ-40346527 in participants with mild cognitive impairment.
    A.3.2Name or abbreviated title of the trial where available
    MIcroglial CSF1R in AD - MICAD
    A.4.1Sponsor's protocol code number40346527ALZ1001
    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 SponsorUniversity of Oxford / Clinical Trials and Research Governance
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportWellcome Trust
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportJanssen Pharmaceutica NV
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Psychiatry
    B.5.2Functional name of contact pointJennifer Lawson
    B.5.3 Address:
    B.5.3.1Street AddressWarneford Hospital, Warneford Lane, Headington
    B.5.3.2Town/ cityOxford
    B.5.3.3Post codeOX3 7JX
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01865613104
    B.5.6E-mailjennifer.lawson@psych.ox.ac.uk
    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-40346527-AAC-G-002
    D.3.2Product code JNJ-40346527-AAC-G-002
    D.3.4Pharmaceutical form Capsule, hard
    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 1142364-35-9
    D.3.9.2Current sponsor codeJNJ-40346527-AAC
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 placeboCapsule, hard
    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
    Mild Cognitive Impairment
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Placebo-controlled change from baseline in levels of CSF fluid protein markers including but not limited to IL-34 and CSF1.
    E.2.2Secondary objectives of the trial
    1. To investigate the effect of 300 mg JNJ-403346527 administered twice daily on other blood and CSF biomarkers including:
    a. Exploratory markers of target engagement
    b. Other markers of inflammation
    c. (Exploratory) markers of disease
    2. To investigate the effect of 300 mg JNJ-40346527 administered twice daily on the CSF extracellular vesicles and cell population.

    3. To characterise the plasma PK profile of JNJ-40346527 and measure JNJ-40346527 concentration in the brain (CSF).

    4. To investigate the effect of minimally efficacious JNJ-40346527 dose level on CSF biomarkers.

    5. To investigate the effect of JNJ-40346527 on neuroinflammation as measured by neuroimaging.

    6. To investigate the effect of JNJ-40346527 on cognition.

    7. To investigate the effect of JNJ-40346527 on participant wellbeing.

    8. To investigate the safety and tolerability of JNJ-40346527 in participants with mild amnestic cognitive impairment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Any gender over and including 50 years old
    - Willing and able to provide informed consent
    - CDR Global score = 0.5
    - Self and/or study partner report and impairment on objective cognitive tasks (performance on Hopkin’s verbal learning task (HVLT) – delay recall and/or free recall > 1 standard deviation (SD) below mean for age/education level).
    -Study Partner available, that spends at least 4 hours per week with the participant. The Study Partner must be willing and able to assist with the CDR interview, and will be provided with their own Information Sheet and Informed Consent form.
    - Able to read and write in English and with 7 minimum years formal education
    - Be considered eligible according to TB screening criteria
    - Be healthy on the basis of clinical laboratory tests performed at screening.
    - Women must be postmenopausal
    - Men who are heterosexually active must agree to use a double-barrier method of birth control and to not donate sperm during the study and for 6 months after last dose
    - Be willing to adhere to all of the procedures, prohibitions amd restrictions specified in the protocol.
    E.4Principal exclusion criteria
    • Research participants who fulfil diagnostic criteria for any type of dementia (e.g. Alzheimer Dementia, Frontotemporal Dementia (FTD), Diffuse Lewy Body Dementia (DLBD), Vascular Dementia (VAD), etc)
    CDR ≥1.
    • Known carriers of a presenilin 1 (PSEN1), presenilin 2 (PSEN2) or APP mutation associated with Autosomal Dominant AD or any other neurodegenerative disease.
    • Prohibited or restricted concomitant medication as detailed in Section 10.1.7 in the protocol.

    • Presence of any neurological, psychiatric or medical conditions associated with a long-term risk of significant cognitive impairment or dementia including but not limited to pre-manifest Huntington’s disease, multiple sclerosis, Parkinson’s disease, Down syndrome, active alcohol/drug abuse or major psychiatric disorders including current major depressive disorder, schizophrenia, schizoaffective or bipolar disorder. To quantify abuse is to define this as history of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th Edition) (DSM-V) criteria within 6 months before screening or positive test result for alcohol and/or drugs of abuse at screening/admission.
    • History of latent or active infection of one of the following infectious diseases at screening: Listeria infection, Histoplasma, Coccidioides, Paracoccidioides, Pneumocystis, nontuberculous mycobacteria, Blastomyces, Aspergillus, cytomegalovirus generalised or Herpes zoster infection
    • Any cancer or history of cancer in the preceding 5 years (excluding cutaneous basal or squamous cell cancer resolved by excision).
    • Any conditions that are clinically significant and may deem the participant’s participation in an investigational trial unsafe, e.g., symptomatic cardiovascular disease (including re-vascularisation procedures within the previous year), severe renal or hepatic failure, any clinically relevant abnormalities in blood parameters included in local routine assessments, severe loss of vision, hearing or communicative ability, conditions preventing co-operation or completing the required assessments in the trial, as judged by the Investigator.
    • Any contraindications for PET/MRI scanning.
    • Any contraindications for Lumbar Puncture.
    • Any evidence of intracranial pathology which may affect cognition including but not limited to brain tumours (benign or malignant), aneurysm or arteriovenous malformations, territorial stroke (excluding smaller watershed strokes), history of or recovering haemorrhage (parenchymal or subdural), or obstructive hydrocephalus. Research participants with an MRI scan demonstrating markers of small vessel disease (e.g. white matter changes or lacunar infarcts) judged to be clinically insignificant, or microbleeds are allowed.
    • Participation in a clinical trial with an Investigational Medicinal Product (IMP) in the last 30 days or 90 days in case of biologics.
    • Diminished decision-making capacity that renders the individual not capable of consenting.
    • Any other factors in the opinion of the Investigator that could contraindicate the participation of the research participant into this trial.
    E.5 End points
    E.5.1Primary end point(s)
    Placebo-controlled change from baseline in levels of CSF fluid protein markers including but not limited to IL-34 and CSF1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 5 (Day 11 - 14).
    E.5.2Secondary end point(s)
    1. To investigate the effect of 300 mg JNJ-403346527 administered twice daily on other blood and CSF biomarkers including:

    a. Exploratory markers of target engagement
    b. Other markers of inflammation
    c. (Exploratory) markers of disease

    2. To investigate the effect of 300 mg JNJ-40346527 administered twice daily on the CSF extracellular vesicles and cell population.

    3. To characterise the plasma PK profile of JNJ-40346527 and measure JNJ-40346527 concentration in the brain (CSF).

    4. To investigate the effect of minimally efficacious JNJ-40346527 dose level on CSF biomarkers.

    5. To investigate the effect of JNJ-40346527 on neuroinflammation as measured by neuroimaging.

    6. To investigate the effect of JNJ-40346527 on cognition.

    7. To investigate the effect of JNJ-40346527 on participant wellbeing.

    8. To investigate the safety and tolerability of JNJ-40346527 in participants with amnestic mild cognitive impairment.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visit 4 (Day 10 - 13) AND Visit 5 (Day 11 - 14).

    There is overlap here, however the Protocol specifies that Visit 5 can only take place when a participant has had Visit 4.
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Exploratory biomarker effects
    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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States No
    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 Yes
    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
    Participants will only be considered to have completed the study if they have completed assessments through the last visit of the single-blind treatment phase. The End of Trial is considered as the last contact for the last participant in the study. The final data from the study site will be sent to the sponsor (or designee) after completion of the final participant contact at that study site, in the time-frame specified in the Clinical Trial Agreement.
    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 months8
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    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 state54
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 54
    F.4.2.2In the whole clinical trial 54
    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)
    There is no provision for continued supply of JNJ-40346527 after the study. This drug is not anticipated to have any therapeutic benefit for participants due to the short duration of this study.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation CSM On Demand
    G.4.3.4Network Country Belgium
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-06-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-07
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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