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    Summary
    EudraCT Number:2014-003117-28
    Sponsor's Protocol Code Number:EPU-P77
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-08-21
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2014-003117-28
    A.3Full title of the trial
    Can Methylphenidate (Ritalin) improve memory and attention in mild cognitive impairment? An EEG study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Can Ritalin improve memory and attention in participants with memory impairment?
    A.3.2Name or abbreviated title of the trial where available
    Ritalin and memory in MCI
    A.4.1Sponsor's protocol code numberEPU-P77
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    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 Ritalin
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharma B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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 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
    memory impairment in patients with Mild Cognitive Impairment
    E.1.1.1Medical condition in easily understood language
    Memory impairment diagnosed in an elderly population which is more than normal, but not yet in the Alzheimer stage.
    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 17.0
    E.1.2Level LLT
    E.1.2Classification code 10027174
    E.1.2Term Memory impaired
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10027175
    E.1.2Term Memory impairment
    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
    We aim to examine, in patients with Mild Cognitive Impairment of the amnestic and those of the non-amnestic type, whether a treatment using methylphenidate, a dopamine re-uptake inhibitor that enhances dopamine, improves memory and attention. This will be assessed using a verbal learning task (VLT), which measures storage, consolidation and retrieval of episodic memory using word lists. The main parameters will be the behavioural scores of the participants as well as the brain responses during this paradigm.
    E.2.2Secondary objectives of the trial
    In the current study, three different memory/attention paradigms will be used that measure different aspects of memory. In that way, we will obtain a broader view on the effects of methylphenidate on memory. The second test (see the primary objective for the first) is an n-back test (n-back) that assesses most of all attention and partly also updating of working memory. The third task is the Sustained attention to response (SART) test, which examines attention and vigilance. Both behavioural responses during the n-back and SART, as well as the brain responses during these tests, will serve as secondary objective. Finally, a fourth test that specifically examines motor activity (choice reaction time test, CRT) will be used to examine potential beneficial effects on psychomotor activity.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • The participant has been diagnosed with Mild Cognitive Impairment, either of the amnestic or the non-amnestic type.
    • In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
    • The participant signs and dates a written informed consent form.
    • The volunteer is male or female.
    • The participant is aged 60 to 80 years, inclusive, at the time of informed consent.
    • The participant has a body mass index of 18.5-30, inclusive, at medical screening.
    • The volunteer is healthy, i.e. absence of all exclusion criteria and has normal static binocular acuity (corrected or uncorrected) as well as normal hearing (using a whisper test during medical screening).
    E.4Principal exclusion criteria
    • The subject has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality which may impact the ability of the subject to participate or potentially confound the study results.
    • The volunteer has uncontrolled existing major psychiatric symptoms.
    • The subject has uncontrolled hypertension.
    • The volunteer has hyperthyroidism.
    • The participant has known hypersensitivity to any component of the formulation of MPH or related compounds.
    • The participant has glaucoma.
    • The subject has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the first visit or is unwilling to agree to abstrain from alcohol from 24 hours prior to each test day and/or drugs throughout the study.
    • The participant has any sensory or motor deficits which could reasonably be expected to affect test performance.
    E.5 End points
    E.5.1Primary end point(s)
    The main endpoints are the total number of words recalled at immediate recall in a verbal learning test (VLT); the number of words recalled in VLT at a delay of 30 minutes; accuracy and reaction time of the recognition test of VLT; the amplitude of the N400 and P600 event-related potential (ERP) components during encoding and recognition of words of the VLT, as measured using EEG.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Immediate recall is assessed 140 minutes after intake of methylphenidate.
    Delayed recall is assessed 175 minutes after intake of methylphenidate.
    Delayed recognition is assessed 180 minutes after intake of methylphenidate.
    E.5.2Secondary end point(s)
    Secondary endpoints are performance on the visual and auditory N-back test, a sustained attention to response tak (SART) and a motor task; amplitude of ERP components during the visual and auditory N-back test, as well as the SART.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The visual and auditory N-back test is performed 150 minutes after methylphenidate intake.
    The SART is assessed 165 minutes after methylphenidate intake.
    The motor task is done 170 minutes after intake of methylphenidate.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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 Yes
    E.6.13.1Other scope of the trial description
    Cognitive effects (i.e., memory and attention enhancing effects)
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 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
    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
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state40
    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)
    None
    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 Decision2014-08-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-03
    P. End of Trial
    P.End of Trial StatusOngoing
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