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    Summary
    EudraCT Number:2013-000397-30
    Sponsor's Protocol Code Number:MADE
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-06-25
    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 number2013-000397-30
    A.3Full title of the trial
    Minocycline in Alzheimer's disease efficacy trial:The MADE trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Minocycline in Alzheimer’s Disease Efficacy (MADE) Trial
    A.3.2Name or abbreviated title of the trial where available
    MADE
    A.4.1Sponsor's protocol code numberMADE
    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 SponsorKing's College London
    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 supportMRC/NIHR Efficacy and Mechanism Evaluation Programme
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKing's College London
    B.5.2Functional name of contact pointRobert Howard
    B.5.3 Address:
    B.5.3.1Street AddressInstitute of Psychiatry, Box P070, De Crespigny Park, Denmark Hill
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE5 8AF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number4402078480545
    B.5.6E-mailrobert.j.howard@kcl.ac.uk
    B.Sponsor: 2
    B.1.1Name of SponsorSouth London and Maudsley NHS Foundation Trust
    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 supportMRC/NIHR Efficacy and Mechanism Evaluation Programme
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKing's College London
    B.5.2Functional name of contact pointRobert Howard
    B.5.3 Address:
    B.5.3.1Street AddressInstitute of Psychiatry, Box P070, De Crespigny Park, Denmark Hill
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE5 8AF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number4402078480545
    B.5.6E-mailrobert.j.howard@kcl.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 Yes
    D.2.1.1.1Trade name Acnamino MR 100mg capsules
    D.2.1.1.2Name of the Marketing Authorisation holderDexcel®-Pharma Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical 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.3.8INN - Proposed INNminocycline hydrochloride
    D.3.9.1CAS number 13614-98-7
    D.3.9.3Other descriptive nameMINOCYCLINE
    D.3.9.4EV Substance CodeSUB08980MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    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
    Alzheimer's Disease
    E.1.1.1Medical condition in easily understood language
    Alzheimer's Disease
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    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
    To determine whether minocycline is superior to placebo in slowing the disease course of early AD, over a 2-year period, measured by reduced rate of decline in:
    (i) Cognition.
    (ii) Function.
    E.2.2Secondary objectives of the trial
    The secondary objectives of MADE are:
    (i) To compare the safety and tolerability of minocycline at doses of 400mg/day and 200mg/day
    (ii) To determine whether 400mg/day offer superior neuroprotection to 200mg/day.
    (iii) To investigate associated risks of side-effects and serious adverse events.
    (iv) To estimate the magnitude of any statistically significant positive treatment effects on cognitive and functional decline and thereby inform the design and powering of a future phase III trial of definitive clinical effectiveness within the NHS.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Diagnosis of possible or probable AD by NIA/AA criteria (McKhann et al 2011).
    • sMMSE score >23 with no upper limit.
    • Giving informed consent to participate.
    • Aged 50+
    • Participants must have a potential informant who will assist in the administration of the BADLS
    E.4Principal exclusion criteria
    • Known allergy to tetracycline antibiotics.
    • Female of childbearing potential. Patients must be surgically sterile (hysterectomy, bilateral salpingectomy / oophorectomy) for at least 6 months minimum or have undergone bilateral tubal occlusion / ligation at least 6 months prior or have been post-menopausal for at least 1 year.
    • Uncontrolled serious concomitant illness
    • Known chronic kidney disease stages 3b-5
    • Moderate liver disease (see Child-Pugh for Classification of Severity of Liver Disease)
    • Abnormal serum chemistry laboratory value at Screening deemed to be clinically relevant by the investigator.
    • Withholds consent for the study team to inform his/her GP
    • Systemic Lupus Erythromatosus (SLE).
    • Participation in another Clinical Trial of an Investigational Medicinal Product (IMP) in the previous 28 days.
    E.5 End points
    E.5.1Primary end point(s)
    (i) Cognitive function measured by the Standardised Mini-Mental State Examination
    (ii) Functional ability measured with the Bristol Activities of Daily Living Scale
    E.5.1.1Timepoint(s) of evaluation of this end point
    6, 12, 18 and 24 months
    E.5.2Secondary end point(s)
    i) Blood monitoring of haematopoetic, renal and hepatic function will be carried out every 6 months
    ii)documentation of skin reactions, gastrointestinal and neurological symptoms
    E.5.2.1Timepoint(s) of evaluation of this end point
    i) 6, 12, 18, 24 months
    ii) every 3 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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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) 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 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 trial3
    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 concerned18
    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
    LVLP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days30
    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: 560
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 560
    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 Yes
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    People with mild Alzheimer's disease
    F.4 Planned number of subjects to be included
    F.4.1In the member state560
    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)
    Arrangements for continued treatment at the end of the trial will be made on an individual patient basis by the PI or other clinicians responsible for the patient’s care at this point.
    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 Decision2013-07-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-04-16
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