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    The EU Clinical Trials Register currently displays   36093   clinical trials with a EudraCT protocol, of which   5934   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2013-000962-13
    Sponsor's Protocol Code Number:U1111-1131-9252
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-06-13
    Trial 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 number2013-000962-13
    A.3Full title of the trial
    Evaluating the effects of the novel GLP-1 analogue, liraglutide, in patients with Alzheimer’s disease (ELAD study)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ELAD Study
    A.3.2Name or abbreviated title of the trial where available
    ELAD study
    A.4.1Sponsor's protocol code numberU1111-1131-9252
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01843075
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1131-9252
    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 SponsorImperial 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 supportNovo Nordisk A/S
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportAlzheimer's Society
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportAlzheimer's Drug Discovery Foundation
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportVan Geest Foundation
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationImperial College London and Imperial College Healthcare NHS Trust
    B.5.2Functional name of contact pointNabila Youssouf
    B.5.3 Address:
    B.5.3.1Street AddressJoint Research Compliance Office, Room 510, Lab Block,Charing Cross Hospital
    B.5.3.2Town/ cityFulham Palace Road, London
    B.5.3.3Post codeW6 8RF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02033110213
    B.5.5Fax number02033110203
    B.5.6E-mailnabila.youssouf@imperial.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 Victoza
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk A/S
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameVictoza
    D.3.2Product code EMEA/H/C/001026
    D.3.4Pharmaceutical form Solution for injection in pre-filled pen
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLiraglutide
    D.3.9.1CAS number 204656-20-2
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 placeboSolution for injection in pre-filled pen
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with mild Alzheimer’s dementia as defined by NINCDS-ADRDA Criteria for Probable Alzheimer’s dementia or meeting NIA-AA criteria for early AD, with MMSE ≥22 and a CDR Global score of 0.5 or 1 using the University of Washington on-line algorithm
    E.1.1.1Medical condition in easily understood language
    Treatment of patients with early / mild Alzheimer’s dementia
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10012271
    E.1.2Term Dementia Alzheimer's type
    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
    A 12-month, multicentre randomised double-blind placebo-controlled study in patients with mild Alzheimer’s dementia. Patients will be randomised on a 1:1 ratio to receive liraglutide or identical matching placebo. Participants will be maintained at the highest well-tolerated dose level (either 1.2 or 1.8 mg).

    Is there a change in cerebral glucose metabolic rate (rCMRglc) in composite cortical region (hippocampal, medial temporal lobe and posterior cingulate) from baseline to follow up (12 months) in the treatment group compared with the placebo group?
    E.2.2Secondary objectives of the trial
    1. The change from baseline to 12 months in z-scores for the cognitive tests (logical memory, battery of other neuropsychometric tests) in the treatment group compared with the placebo group
    2. The incidence and severity of treatment emergent adverse events or clinically important changes in safety assessments over 12 months
    3. Is there a reduction in microglial activation in subjects with mild AD following daily subcutaneous injection of liraglutide for 1 year using TSPO ([18F]GE180) PET scanning compared to subjects receiving placebo injections in a subgroup of patients?
    4. The change in the MRI volume measures in the brain (entorhinal cortex and hippocampal volume, and ventricular volume) from baseline to 12 month in the treatment group compared with the placebo group.
    5. The change from baseline to 12 months in the composite scores using Support Vector Machine algorithm derived from neuropsychometric tests, changes in the MRI derived numerical summaries (hippocampal, temporal
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male/female aged 50-85.
    2. Capable of giving and capacity to give informed consent.
    3. A carer who can act as a reliable study partner.
    4. Diagnosis of probable Alzheimer's disease according to NIA-AA criteria.
    5. Mini-Mental State Examination (MMSE) score of ≥22.
    6. Rosen Modified Hachinski Ischemic score ≤4.
    7. On stable medication for 3months; on or off Cholinesterase inhibitors.
    8. Fluency in English and evidence of adequate premorbid intellectual functioning.
    9.Likely to be able to participate in all scheduled evaluations and complete all required tests.
    E.4Principal exclusion criteria
    1.Any contraindications to the use of Liraglutide as per the Summary of Product Characteristics. (hepatic impairment, renal impairment with CKD stage 3 and above, inflammatory bowel disease).
    2.Significant neurological disease other than AD that may affect cognition.
    3.MRI/CT showing unambiguous aetiological evidence of cerebrovascular disease with regards to their dementia.
    4.Diabetes Mellitus.
    5.Currently taking or having taken memantine on the 30 days prior to screening.
    6.Current presence of a clinically significant major psychiatric disorder (e.g. Major Depressive Disorder) according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV).
    7.Current clinically significant systemic illness that is likely to result in deterioration of the patient’s condition or affect the patient’s safety during the study.
    8. History of seizures, excluding febrile seizures in childhood.
    9. Treatment with immunosuppressive medications (e.g. systemic corticosteroids) within the last 90 days (topical and nasal corticosteroids and inhaled corticosteroids for asthma are permitted) or chemotherapeutic agents for malignancy within the last 3 years.
    10. Myocardial infarction within the last 1 year.
    11. History of cancer within the last 5 years.
    12. Other clinically significant abnormality on physical, neurological, laboratory, examination that could compromise the study or be detrimental to the patient.
    13. History of alcohol or drug dependence or abuse within the last 2 years.
    14. Current use of anticonvulsant, anti-Parkinson’s, anticoagulant (excluding the use of aspirin 325 mg/day or less) or narcotic medications.
    15. Use of experimental medications for AD or any other investigational medication or device within 60 days. Patients who have been involved in a monoclonal antibody study are excluded unless it is known that they were receiving placebo in that trial.
    16. Women of childbearing potential. Women who could become pregnant will be required to use adequate contraception throughout the trial.
    17. Patients with a personal or family history of medullary thyroid carcinoma (MTC) and patients with multiple endocrine neoplasia type 2 (MEN2).
    E.5 End points
    E.5.1Primary end point(s)
    Primary outcome:
    The change in cerebral glucose metabolic rate in the composite cortical region of the brain from baseline to follow up (12 months) in the treatment group compared with the placebo group.

    E.5.1.1Timepoint(s) of evaluation of this end point
    Twelve months after baseline assessments.
    E.5.2Secondary end point(s)
    Key secondary outcomes:
    1 - The change from baseline to 12 months in z-scores for the ADAS Exec (ADAS-cog and the Executive domain scores from the Neuropsychological Test Battery in the treatment group compared to the placebo group.
    2 - The incidence and severity of treatment emergent adverse events or clinically important changes in safety assessments over 12 months.

    Other secondary outcomes:
    1 - The change in the entorhinal cortex and hippocampal volume from baseline to 12 months in the treatment group compared with the placebo group.
    2 - To establish whether there is a reduction in microglial activation in subjects with mild AD following daily subcutaneous injection of liraglutide for 1 year using TSPO PET scanning compared with subjects receiving placebo injections in a subgroup of patients.
    3 - The change from baseline to 12 months in the composite scores using Support Vector Machine algorithm derived from neuropsychometric tests, changes in the MRI derived numerical summaries (hippocampal, temporal and ventricular volume), changes in [18F]FDG-PET, ApoE4 status and age.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Twelve months after baseline assessments.
    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 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 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 concerned6
    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
    Last visit of last subject (LVLS)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 136
    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 state206
    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)
    All these subjects will be followed up in the outpatient clinics for their regular clinical care.
    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 North Thames Dementias and Neurodegenerative Diseases Research Network (DeNDRoN)
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-08-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-06
    P. End of Trial
    P.End of Trial StatusOngoing
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