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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
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    The EU Clinical Trials Register currently displays   42758   clinical trials with a EudraCT protocol, of which   7042   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2016-000891-54
    Sponsor's Protocol Code Number:REBOOT-II
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-10-05
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSweden - MPA
    A.2EudraCT number2016-000891-54
    A.3Full title of the trial
    Effects of enhanced dopaminergic neurotransmission on working memory training efficiency in the healthy elderly - A prospective, single center, randomized, double blind, placebo controlled, parallel group, phase II trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    REBOOT: Releasing the brakes on adult plasticity
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberREBOOT-II
    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 SponsorAging Research Center, Karolinska Institutet and Stockholm University
    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 supportEuropean Research Council
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAging Research Center, Karolinska Institutet and Stockholm University
    B.5.2Functional name of contact pointMarie Helsing
    B.5.3 Address:
    B.5.3.1Street AddressGävlegatan 16
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post code11330
    B.5.4Telephone number+4608690 59 69
    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. name Madopark Quick
    D. of the Marketing Authorisation holderRoche AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    No medical condition is under investigation. The project investigates normal age-related decline in intellectual abilities.
    E.1.1.1Medical condition in easily understood language
    No medical condition is under investigation. The project investigates normal age-related decline in intellectual abilities.
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate effects of enhanced dopaminergic neurotransmission on efficiency of working memory training for improving fluid intelligence (reasoning).
    E.2.2Secondary objectives of the trial
    To study effects of enhanced dopaminergic neurotransmission on efficiency of working memory training for improving episodic memory, creativity, switching and updating performance.

    To study effects of dopamine-enhanced working memory training on structural and functional brain connectivity.

    To investigate effects of dopamine-enhanced working memory training on plasma and CSF markers of brain plasticity (e.g. BDNF), dopamine metabolism (e.g. homovanillic acid, monoamine oxidase) and neurodegeneration (e.g. tau, p-tau, Abeta).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Mini-Mental State Examination score >26;
    • Aged between 65 and 75 years;
    • Absence of medical or psychiatric conditions specified in the exclusion criteria;
    • Signed informed consent;
    • Right handedness;
    • Fluent Swedish;
    • Absence of colorblindness;
    • No previous participation in studies of similar design;
    • No trauma to the head with loss of consciousness for more than 10 min;
    • No history of brain injuries;
    • No hormonal imbalance diseases (e.g. Cushing’s syndrome);
    E.4Principal exclusion criteria
    • Glaucoma (any history);
    • Any history of serious heart disease (myocardial infarction, arrhythmia, atrioventricular block);
    • Serious problems with heart and blood vessels, systolic/diastolic blood pressure < 100/50 or >160/95; Heart Failure: NYHA > IB; Chronic Venous Disease CEAP > C2);
    • Severe pulmonary diseases;
    • Type I diabetes;
    • Recent history (5 years) of stomach and duodenum ulcers;
    • Liver diseases (e.g. hepatitis, liver failure);
    • Bleeding of the stomach or intestines;
    • Kidney diseases;
    • Serious urination problems;
    • Recent history (5 years) of malignant tumor or mole, melanoma;
    • Major psychiatric disorders such as major depression, bipolar affective disorder, psychosis (risks of exacerbation of psychiatric symptoms). History of mild to moderate depression/anxiety is allowed (but not recent: 5 year cut-off);
    • Patients with neurological (Parkinson's and other movement disorders, Alzheimer's disease, epilepsy) disorders will also be excluded, as the present project targets healthy elderly population;
    • MRI contra-indications: metal body implants and pacemakers, cochlear implants, claustrophobia, weight over 120 kg;
    • Hypersensitivity to pro-dopaminergic drugs;
    • Hypersensitivity to citrus fruits/ascorbic acid;
    E.5 End points
    E.5.1Primary end point(s)
    Fluid intelligence defined by multi-test latent composite scores as follows:

    - Spatial Intelligence (BETA-III, WASI-II, Raven's matrices)
    - Verbal Intelligence (BIS analogies, Syllogisms, ETS Kit inference)
    E.5.1.1Timepoint(s) of evaluation of this end point
    During week 8 (visits 29-33) and week 35 (visits 36-40), compared to baseline week 2 (visits 3-7).
    E.5.2Secondary end point(s)
    1. Multi-test latent composite scores of performance on tasks measuring episodic memory, creativity, switching and updating performance.

    2. Functional (measured with functional magnetic resonance imaging) and structural (measured with diffusion-tensor imaging) connectivity within the fronto-parietal and fronto-subcortical circuits and cortical thickness within the fronto-parietal network.

    3. Plasma and CSF markers of plasticity (e.g. DNF), dopamine metabolism (e.g. homovanillic acid, monoamine oxidase) and neurodegeneration (e.g.tau, p-tau, Abeta).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. During week 8 (visits 29-33) and week 35 (visits 36-40), compared to baseline week 2 (visits 3-7).

    2. During week 9 (visit 34), compared to baseline week 3 (visit 8).

    3. Plasma levels will be evaluated during week 7 (visit 28), compared to baseline week 4 (visit 9). CSF levels will be evaluated during week 9 (visit 35).
    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 No
    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. 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 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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 state70
    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)
    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 Decision2016-11-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-17
    P. End of Trial
    P.End of Trial StatusOngoing
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