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    Summary
    EudraCT Number:2011-000794-31
    Sponsor's Protocol Code Number:October2011,version5
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-06-01
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2011-000794-31
    A.3Full title of the trial
    Neurodegenerative Changes in Alzheimer’s Disease: Identifying potential effects of Victoza® on degenerative changes
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The GLP-1 receptor agonist liraglutide can slow down the progression of Alzheimer’s disease


    A.4.1Sponsor's protocol code numberOctober2011,version5
    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 SponsorDept. of Pharmacology
    B.1.3.4CountryDenmark
    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 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 Yes
    D.2.1.1.1Trade name Victoza
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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 placeboInjection
    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
    Alzheimer's disease
    E.1.1.1Medical condition in easily understood language
    Dementia is most often caused by Alzheimers disease which results in a decrease in cognitive functions and leads to ealier death
    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 14.0
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    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
    To examine the effect of a 6 month treatment course with Victoza, a GLP-1 receptor agonist, on intracerebral amyloid aggregations determined by Pittsburgh Compound B PET-scans.
    E.2.2Secondary objectives of the trial
    To examine the effect of a 6 month treatment course with Victoza, a GLP-1 receptor agonist, on the clinical course of AD as determined by validated neuropsychological tests (MMSE and Addenbrookes cognitive evaluation test).
    Secondary 2:
    To examine the effect of a 6 month treatment course with Victoza, a GLP-1 receptor agonist, on FDG metabolism in the brain as determined by PET-scans
    To examine the effect of a 6 month treatment course with Victoza, a GLP-1 receptor agonist, by MR scans.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients diagnosed with AD by MMSE score and/or spinal puncture (If MMSE score is between 18-21 the patient is diagnosed by clinical symptoms only. If the MMSE score is > 22 a spinal puncture will be performed to diagnose the patient)
    Age ≥ 50 years and ≤ 80 years
    E.4Principal exclusion criteria
    Diabetes mellitus
    Liver or kidney insufficiency (alanine transferase levels more tha twice upper normal, plasma creatinine > 130µmol/l), clinical relevant anaemia
    Current or earlier presence of another CNS disease (except for well-treated depression) or clinical relevant liver disease, kidney disease or endocrinological disease (except hypothyreoism).
    Current or history of chronic or acute pancreatitis
    If patients are treated with SSRI or SSRI similar drugs or antihypertensives this treatment should be stable
    Claustrophobia or other missing co-orporation
    Severe overweight > 130kg
    Ferro-magnetic prosthesis, pacemaker or other metals incorporated in the body
    Significant abnormities in the brain detected by MR scanning

    Known abuse of alcohol or drugs
    Every disease or treatment that the head investigator considers to have a possible effect on results of the study
    Allergy to the drugs or diagnosing procedure used in the study
    Participation in a clinical study 3 months prior to inclusion in this study
    Patients who have previously participated in investigations with isotopes or ionizing radiation
    E.5 End points
    E.5.1Primary end point(s)
    Pittsburgh Compound B PET scanning will be used to examine the primary objective of the study.
    Positron emission tomography (PET) scanning is an establisehed method for the demonstration of CNS changes caused by AD, including changes in deposits of amyloid. In AD patients, PET can be used to investigate changes in glucose metabolism, different neurotransmitter systems, neuroinflammation and protein deposits, amyloid deposits in particular. Amyloid beta accumulations are crucial patological findings in AD. Recently, amyloid tracers have been developed for PET which makes in vivo amyloid visualisation possible. It has been shown that the carbon-11 labelled Pittsburgh Compound B (PiB) PET tracer can be used to study amyloid deposits in living humans. PiB was among the first PET tracers to visualise amyloid and its effect is among the most well documented. Patients are not expected to experience any short- or long-term discomfort from the PET scans, apart from that assosiated to the insertion of cannulas.

    E.5.1.1Timepoint(s) of evaluation of this end point
    January 2013
    E.5.2Secondary end point(s)
    Secondary1:
    To study the effect of a 6 month treatment course with liraglutide we will use validated neuropsychological tests (MMSE and Addenbrookes cognitive evaluation test) developed to characterization of disease progression in patients with AD.

    Secondary2:
    Moreover, we want to examine the effect of a 6 month treatment course with liraglutide, on FDG metabolism in the brain as determined 18F-flouro-2-deoxy-glucose PET-scans (FDG PET).
    A recent study have demonstrated that the glucose-analog 18F-flouro-2-deoxy-glucose PET tracer can be used to monitor the progressive reduction in cerebral glucose metabolism in patients with AD before clinical symptoms appear.

    Secondary3:
    At the 1st and last visit a perfusion-weighted MR scan of the brain will be performed. The perfusion-weighted MR-scan is a supplying marker for the severity of Alzheimer’s disease and can improve the sensitivity of the study drug’s effect in the brain.
    E.5.2.1Timepoint(s) of evaluation of this end point
    January 2013
    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 trial1
    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 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 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
    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 months6
    E.8.9.1In the Member State concerned days
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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.3.3.6.1Details of subjects incapable of giving consent
    Patients with Alzheimers disease
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    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 Decision2011-06-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-04-11
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