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    Summary
    EudraCT Number:2016-003109-32
    Sponsor's Protocol Code Number:1
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2018-05-16
    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 number2016-003109-32
    A.3Full title of the trial
    An investigation of Levetiracetam in Alzheimer’s Disease (ILiAD): a proof of concept study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An investigation of Levetiracetam in Alzheimer’s Disease (ILiAD): a proof of concept study
    A.3.2Name or abbreviated title of the trial where available
    The ILiAD Study
    A.4.1Sponsor's protocol code number1
    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 SponsorUniversity of Oxford
    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 supportMedical Research Council
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportUCB Pharma
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Oxford
    B.5.2Functional name of contact pointArjune Sen
    B.5.3 Address:
    B.5.3.1Street AddressNuffield Department of Clinical Neurosciences
    B.5.3.2Town/ city3rd Floor, West Wing
    B.5.3.3Post codeOX3 9DU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01865231891
    B.5.6E-mailarjune.sen@ouh.nhs.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 Keppra
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Pharma
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameKeppra
    D.3.4Pharmaceutical form Tablet
    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 INNLevetiracetam
    D.3.9.1CAS number 102767-28-2
    D.3.9.2Current sponsor codeUCB CODE LO59
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 placeboTablet
    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 is the most common type of dementia. Dementia is a condition which typically affects older people and impairs memory and thinking without affecting the level of consciousness
    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 20.0
    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
    Does the anti-epileptic medication Levetiracetam offer benefit to cognition in patients with AD who have not experienced an overt seizure
    E.2.2Secondary objectives of the trial
    To determine if use of Levetiracetam is associated with significant side effects in patients with AD that have not experienced an overt seizure

    To determine if use of Levetiracetam is associated with an effect on mood in patients with AD that have not experienced an overt seizure

    To determine if use of Levetiracetam is associated with changes in quality of life in patients with AD that have not experienced an overt seizure or a change in the quality of life of their carers

    To evaluate whether the electroencephalogram can be used as a surrogate marker to better predict which patients with AD may respond to treatment with Levetiracetam
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All participants:
    • Participant is willing and able to give informed consent for participation in the trial.
    • Participant has English as their first language

    Participants with AD

    • Male or Female, 50 years or above.
    • Diagnosed with mild to moderate AD (MMSE 10 to 26)
    • Meets the National Institute of Aging-Alzheimer's Association criteria for probable AD (2011)
    • Stable dose of current regular medication, including aceytlcholinesterase inhibitors if applicable, for at least 4 weeks prior to trial entry.
    • Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the trial and for 3 months thereafter.
    • Participant has clinically acceptable blood and urine test results (creatinine clearance >75 ml/minute; liver function tests <2x upper limit of normal) and ECG that does not demonstrate conduction block or significant ischaemia within three months of enrolment.
    • In the Investigator’s opinion, is able and willing to comply with all trial requirements.
    • Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial.
    • Reliable carer available

    Carer of participant with AD
    • Male or Female aged 18 and above.
    • Principal carer for the participant with AD
    • Able to attend all home visit
    E.4Principal exclusion criteria
    The participant may not enter the trial if ANY of the following apply

    Participants with AD
    • Pre-existing diagnosis of epilepsy
    • Clinical or laboratory evidence of a cause other than AD as a cause of their dementia
    • Laboratory evidence of significant renal impairment (creatinine clearance <75 ml/minute) or liver dysfunction (liver function tests >2x upper limit of normal) within the preceding three months
    • Visual or motor impairment that investigator deems severe enough to impair ability to complete computerised based touch screen task
    • Use of anti-epileptic medication including use for an indication other than epilepsy e.g. for pain or migraine within previous three months
    • Other severe neurological or medical condition. Examples include, significant stroke, heart failure, chronic renal failure, chronic liver failure within last 3 months
    • Major depression or other significant behavioural disturbance
    • Known allergy to Levetiracetam or history of previous adverse reaction to Levetiracetam
    Contraindications, warnings and special precautions to Levetiracetam use are not described further in the protocol and the investigator should refer to the Standard Product Characteristics
    • Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
    • Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
    • Participant with life expectancy of less than 6 months, or is inappropriate for placebo medication.
    • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial.

    Participants who have participated in another research trial involving an investigational medicinal product in the past 12 weeks will also be excluded

    Carer of participant with AD
    • Carer has significant medical illness that will preclude adequate data capture during the study
    E.5 End points
    E.5.1Primary end point(s)
    Primary Outcome: Changes in cognition in patients while taking Levetiracetam as measured by computerised assessment of a hippocampal binding memory task
    E.5.1.1Timepoint(s) of evaluation of this end point
    Participants in the ILiAD Study will enter a crossover trial in which they will receive Levetiracetam for 12 weeks and Placebo for 12 weeks.

    There will be assessments at baseline and at the start of the second phase of the trial (12 weeks). Assessments of efficacy will be made at 8 weeks (comparison to baseline) and at 20 weeks (comparison to 12 week assessment)
    E.5.2Secondary end point(s)
    Secondary outcomes:
    1. Determination whether Levetiracetam associates with significant side effects in patients with AD that have not experienced an overt seizure

    2. To determine if use of Levetiracetam associates with an effect on mood in patients with AD that have not experienced an overt seizure

    3. To determine if use of Levetiracetam associates with changes in quality of life in patients with AD that have not experienced an overt seizure or a change in the quality of life of their carers

    4. To evaluate whether the electroencephalogram be used as a surrogate marker to better predict which patients with AD may respond to treatment with Levetiracetam
    E.5.2.1Timepoint(s) of evaluation of this end point
    Participants in the ILiAD Study will enter a crossover trial in which they will receive Levetiracetam for 12 weeks and Placebo for 12 weeks.

    There will be assessments at baseline and at the start of the second phase of the trial (12 weeks).

    End point assessments for secondary objectives 1 to 3 will be made at 8 weeks (comparison to baseline) and at 20 weeks (comparison to 12 week assessment)

    Assessment of the EEG as a surrogate marker will compare baseline assessment of the EEG with cognitive outcomes at 8 and 20 weeks. Once the trial is unblinded, investigators will determine if there is a predictive value of EEG recording on response to Levetiracetam in study subjects
    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 Yes
    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 concerned3
    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
    LVLS
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    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: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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)
    The ILiAD study is a proof of concept study and as such there is not provision for ongoing prescription of Levetiracetam once the study completes
    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 Decision2017-11-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-08
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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