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    Summary
    EudraCT Number:2009-011845-24
    Sponsor's Protocol Code Number:12936A
    National Competent Authority:Czech Republic - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-07-27
    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 ConcernedCzech Republic - SUKL
    A.2EudraCT number2009-011845-24
    A.3Full title of the trial
    Randomised, double-blind, parallel-group, placebo-controlled, fixed-dose study of Lu AE58054 in patients with moderate Alzheimer's Disease treated with donepezil
    A.4.1Sponsor's protocol code number12936A
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorH. Lundbeck A/S
    B.1.3.4CountryDenmark
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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.3.2Product code Lu AE58054
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNN.A.
    D.3.9.1CAS number N.A.
    D.3.9.2Current sponsor codeLu AE58054
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.2.1.1.1Trade name Aricept
    D.2.1.1.2Name of the Marketing Authorisation holderEisai 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.3.1Product nameAricept
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNDONEPEZIL HYDROCHLORIDE
    D.3.9.1CAS number 120011703
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Lu AE58054 is under development by H.Lundbeck A/S for the treatment of Alzheimer's disease.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To explore the effect on cognitive performance, of a fixed dose of Lu AE58054 (90 mg/day) compared to placebo after 24 weeks of treatment in donepezil-treated patients with moderate AD.
    E.2.2Secondary objectives of the trial
    To explore the effect, safety and tolerability of a fixed dose of Lu AE58054 (90 mg/day) compared to placebo after 24 weeks of treatment in donepezil-treated patients with moderate AD on:
     Global impression
     Activities of Daily Living (ADL)
     Behavioural symptoms
     Caregiver burden
    To evaluate the population PK (popPK) of Lu AE58054 and donepezil in patients with moderate AD and relate it to relevant pharmacodynamic (PD) parameters.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The patient (or if applicable the legally acceptable representative (LAR) and if different from the responsible caregiver) and the responsible caregiver are able to read and understand the Informed Consent Form.
    2. The patient has a knowledgeable and reliable caregiver who will accompany the patient to all clinic visits during the study.
    3. The patient (or if applicable the LAR and if different from the responsible caregiver) and the responsible caregiver have signed the Informed Consent Form.
    4. The patient has probable AD consistent with NINCDS-ADRDA criteria.
    5. The patient is a man or woman, aged at least 50 years.
    6. The patient is ambulatory or ambulatory aided (i.e., walker or cane).
    7. The patient, if female, must have had her last natural menstruation at least 24 months prior to baseline or is surgically sterile.
    8. The patient and the caregiver are, in the investigator’s judgement, proficient in the language in which the psychometric tests will be completed.
    9. The patient’s sight and hearing (hearing aid permissible) are, in the investigator’s judgement, sufficient for compliance with the study procedures.
    10. The patient has a MMSE score at screening and baseline of at least 12 and no greater than 19.
    11. The patient has had a CT or a MRI within the last 6 months with results consistent with the diagnosis of probable AD.
    12. The patient has been treated daily with donepezil for at least 4 months prior to the screening visit. The dose has been stable at 10 mg/day for the last 3 months prior to screening.
    13. The patient has a normal physical examination at the screening and baseline visits and normal laboratory evaluations, urine tests and ECG results from the screening visit, or abnormal findings (except ALT, AST, γGT, AP and bilirubin) that are not clinically significant, as judged by the investigator.
    14. The patient has a body mass index (BMI) of 18.5 kg/m2 or above.
    E.4Principal exclusion criteria
    1. The patient has evidence of any clinically significant neurodegenerative disease or other serious neurological disorders other than AD including but not limited to Lewy body dementia, fronto-temporal dementia, Parkinson’s disease, Huntington’s disease, major cortical stroke, major head trauma and, primary or secondary cerebral neoplasia.
    2. The patient has a history of seizures, with the exception of febrile seizures in childhood.
    3. The patient has a DSM-IV-TR Axis I disorder other than AD including amnestic disorders, delirium, schizophrenia or schizoaffective disorder, bipolar disorder, current major depressive episode, psychosis, panic, post traumatic stress disorder or/and cognitive disorder not otherwise specified (note, patients may be included if treated with a stable dose of antidepressants for at least 3 months and not fulfilling DSM-IV-TR criteria for depression at screening).
    4. The patient has clinical and radiological findings that fulfil the standards of the National Institute of Neurological Disorders and Stroke and Association Internationale pour la Recherché et l'Enseignement en Neurosciences (NINDS-AIREN) criteria for vascular dementia.
    5. The patient has CT or MRI evidence of hydrocephalus, stroke, a space-occupying lesion, cerebral infection or any clinically significant central nervous system disease other than AD.
    6. The patient has evidence of clinically significant and active pulmonary, gastrointestinal, renal, hepatic, endocrine or cardiovascular system disease or metabolic disturbance (patients with controlled diabetes, or patients with controlled hypertension, or right bundle branch block, complete or partial, may be included in the study). As specified in the donepezil SPC special precaution is needed for patients with asthma, obstructive pulmonary disease, bradycardia and patients with difficulty in passing urine.
    7. The patient has an untreated B12, or folate deficiency, that is considered clinically significant, or has abnormal thyroid stimulating hormone (TSH) levels. (Note, patients with a history of B12 or folate deficiency may be included in the study provided that they have been on a supplement therapy for at least 3 months and are stable. Patients with thyroid disease may be included in the study, provided they are stable and euthyroid).
    8. The patient has clinically significant abnormal vital signs.
    9. The patient has an ALT, AST, γGT, AP or bilirubin value outside the normal range at
    the screening visit.
    10. The patient has a clinically significant abnormal ECG from the screening visit.
    11. The patient has an oncological diagnosis (haematological or solid tumour) that is currently being treated, or for which there has been treatment within 5 years preceding screening, or for which there is still evidence of active disease (patients with local dermatological tumours such as basal or squamous cell carcinoma may be included).
    12. The patient has/has had a disorder related to alcohol or drug abuse or dependence (other than related to nicotine) as defined in DSM-IV-TR, within 5 years prior to screening.
    13. The patient has a history of severe drug allergy (anaphylactic shock or drug-induced hypersensitivity syndrome), multiple allergies or known hypersensitivity to 5-HT6 receptor antagonists.
    14. The patient used/uses disallowed recent or concomitant medication, or it is anticipated that the patient will require treatment with at least one of the disallowed concomitant medications during the study.
    15. The patient has been treated with a depot neuroleptic within 6 months of the screening visit.
    16. The patient’s donepezil therapy is likely to be interrupted or discontinued during the study.
    17. The patient is currently receiving memantine or has taken memantine within 2 months prior to screening.
    18. The patient has a disease or takes medication that, in the investigator’s judgement, could interfere with the assessments of safety, tolerability, or efficacy.
    19. The patient has been treated with any investigational product within 30 days or five half-lives (whichever is longer) prior to screening (patients treated with immunisation therapy for AD within 2 years of screening are excluded).
    20. The patient has participated in a clinical study with Lu AE58054/SGS518.
    21. The patient is, in the investigator’s judgement, unlikely to comply with the clinical study protocol or is unsuitable for any reason.
    22. The patient is a member of the site personnel or their immediate families.
    23. The patient is treated against his/her will.
    24. The patient or patient caregiver is unwilling or unable to abide by the visit schedule and other requirements of the study.
    25. The patient is, in the investigator’s judgement, likely to be placed in a nursing home within the next 6 months.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in Alzheimer's Disease Assessment Scale-cognitive subscale
    (ADAS-Cog) at week 24.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    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.8.3 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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    The overall end of the study is defined as the last protocol-specified contact with the last patient ongoing in the study.
    After withdrawal from the study or completion of the Safety Follow-up Visit, the patient should be treated according to normal clinical practice.
    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 months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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
    The patient or his/hers legally acceptable representative.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 210
    F.4.2.2In the whole clinical trial 270
    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 Decision2009-10-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-10-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-12-23
    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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