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    Summary
    EudraCT Number:2012-002764-27
    Sponsor's Protocol Code Number:NILVAD2012
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-06-14
    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 ConcernedGermany - BfArM
    A.2EudraCT number2012-002764-27
    A.3Full title of the trial
    A European multicentre double-blind placebo controlled phase III trial of nilvadipine in mild to moderate Alzheimer's disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    NILVAD2012 - a European multicentre double-blind placebo controlled trial of nilvadipine in mild to moderate Alzheimer's disease
    NILVAD2012 – eine europäische placebokontrollierte Multicenterstudie der Behandlung mit Nilvadipine bei leichter bis mittelschwerer Alzheimer Erkrankung
    A.3.2Name or abbreviated title of the trial where available
    NILVAD2012
    A.4.1Sponsor's protocol code numberNILVAD2012
    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 SponsorSt. James Hospital, Ireland
    B.1.3.4CountryIreland
    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 supportSt. James Hospital
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUlm University
    B.5.2Functional name of contact pointProf. Matthias Riepe
    B.5.3 Address:
    B.5.3.1Street AddressLudwig-Heilmeyer Str. 2
    B.5.3.2Town/ cityGünzburgh
    B.5.3.3Post code89312
    B.5.3.4CountryGermany
    B.5.4Telephone number498221962355
    B.5.6E-mailmatthias.riepe@uni-ulm.de
    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 Nivadil
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma, Ireland
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 nameNilvadipine
    D.3.4Pharmaceutical form Capsule
    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 INNNILVADIPINE
    D.3.9.1CAS number 75530-68-6
    D.3.9.4EV Substance CodeSUB09292MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number8
    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
    Alzheimer Erkrankung
    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 16.0
    E.1.2Level HLT
    E.1.2Classification code 10001897
    E.1.2Term Alzheimer's disease (incl subtypes)
    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
    Efficacy of nilvadipine in mild to moderate Alzheimer's disease - cognition
    E.2.2Secondary objectives of the trial
    Efficacy of nilvadipine in mild to moderate Alzheimer's disease - clinical symptoms and activities of daily living
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    5.1.1 Age range: Adult subjects, males and females over age 50 years.
    5.1.2 Subjects with a diagnosis of probable Alzheimer’s disease based on the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer’s disease and Related Disorders Association, Inc (NINCDS-ADRDA) criteria (McKhann et al, 1984) (see Appendix B).
    5.1.3 Subjects with a Standardised Mini-Mental State Examination (SMMSE) (Standish & Molloy, 1997) score of greater than or equal to 12 and less than 27
    5.1.4 Subjects on a stable dose (>3 months) of cholinesterase inhibitor or memantine. The dose must be stabilised prior to randomisation. Patients due to begin these medications must not be enrolled until the dose is stabilised. Subjects who are not on cholinesterase inhibitors or memantine due to poor tolerability and/or who will not require treatment with these medications during the course of the study can be included.
    5.1.5 Subjects who retain capacity will provide written informed consent for participation. The procedure for obtaining informed consent when the subject has reduced decision making capacity will follow national law and will be assessed by the relevant bodies in each of the participating countries.
    5.1.6 Fluency in relevant language sufficient to reliably complete all study assessments.
    5.1.7 Subjects with blood pressure values greater than 100/65mmHg but less than 159/99mmHg (Grade 1 hypertension, ECS guidelines 2007; escardio.org/guidelines) using an office based BP measurement will be included, or subjects with blood pressure values greater than 105/70mmHg but less than 140/90mmHg using an Ambulatory BP measurement will be included.
    E.4Principal exclusion criteria
    5.2.1 Subjects with co-morbid dementia due to other neurological disorders such as Parkinson's disease, vascular dementia, Huntington's disease, Pick's disease, Creutzfeldt-Jakob disease, normal pressure hydrocephalus, brain tumour, progressive supranuclear palsy, seizure disorder, subdural hematoma, or multiple sclerosis, as well as subjects with HIV disease, neurosyphilis, history of significant head trauma with loss of consciousness followed by persistent neurological deficits, known structural brain abnormalities, or any other condition known to interfere with cognitive function.
    5.2.2 Subjects currently taking any calcium channel blocker or b-blocker
    5.2.3 Subjects who in the opinion of the investigator, have a medical condition that would preclude them from participating in the study:e.g. chronic heart failure, syncope within the past year, significant valvular heart disease
    i.e. severe aortic and mitral stenosis symptomatic orthostatic hypotension within the last year, or subjects requiring more than one agent to control BP etc.. Any subject with significant cardiovascular disease including recent history of acute myocardial infarction and unstable angina pectoris.
    Subjects who in the opinion of the investigator are unlikely to complete per protocol due to care issues etc.
    5.2.4 Current Axis I diagnosis of schizophrenia, bipolar disorder, major depression. Subjects who are currently or who have within the past year met criteria for drug or alcohol abuse or dependence.
    5.2.5 Pregnant women or women who may possibly become pregnant (pre-menopausal). Female subjects must be postmenopausal (no menses for ≥ 12 months without an alternative medical cause) to participate in the study.
    5.2.6 Female subjects who are breastfeeding will be excluded from the study.
    5.2.7 Subjects with a history of hypersensitivity to nilvadipine (Nivadil).
    5.3.8 Subjects who have taken an investigational or other unapproved drug during the 30 days or five half-lives, whichever is longer, prior to baseline.
    5. 2.9 Subjects who are taking any medication listed in the list of exclusion medication for the study (see Appendix C).
    5.2.10 Subjects with abnormal ECG results that in the opinion of the clinician prevent participation in the study.
    5.2.11 Standardised Mini-Mental State Examination (SMMSE) score of less than 12 or greater than 26
    5.2.11 Subjects who are participating in other clinical research studies.
    5.2.12 Subjects with any clinically significant laboratory blood test abnormality on his/her screening test.
    5.2.13 Patients with significant renal insufficiency (estimated glomerular filtration rate: eGFR <30ml/min) will be excluded.
    5.2.14 Subjects with severely impaired hepatic function (liver cirrhosis) will be excluded.
    5.2.15 Subjects with blood pressure values less than 100/65mmHg or greater than 159/99mmHg (Grade 1 hypertension, ECS guidelines 2007; escardio.org/guidelines) using an office based BP measurement will be excluded or subjects with blood pressure values less than 105/70mmHg or greater than 140/90mmHg using an Ambulatory BP measurement will be excluded.
    5.2.16 Subjects with clinically significant abnormalities in their CT/MRI results which would prevent inclusion in the study.
    5.2.17 The medical food stuff Souvenaid® is under exclusion from the study.
    E.5 End points
    E.5.1Primary end point(s)
    ADAScog-12
    E.5.1.1Timepoint(s) of evaluation of this end point
    78 weeks
    E.5.2Secondary end point(s)
    Clinical Dementia Rating Scale Sum of Boxes (CDR-sb)
    Disability Assessment for Dementia (DAD)
    E.5.2.1Timepoint(s) of evaluation of this end point
    78 weeks
    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 No
    E.6.5Efficacy No
    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 trial2
    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 EEA11
    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
    at 82 weeks, thus follow-up after 78 weeks of treatment and 4 weeks after cessation of treatment
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 500
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patient not able to give consent will be represented by a guardian
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 500
    F.4.2.2In the whole clinical trial 500
    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)
    Treatment as usual
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-07-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-08-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-12-16
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