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    Summary
    EudraCT Number:2008-008896-32
    Sponsor's Protocol Code Number:MACS(Uni-Koeln-1260)
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-07-21
    Trial results View 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 ConcernedGermany - BfArM
    A.2EudraCT number2008-008896-32
    A.3Full title of the trial
    Memory, Ageing, and the Cholinergic System
    a combined fMRI and PET study
    A.3.2Name or abbreviated title of the trial where available
    MACS
    A.4.1Sponsor's protocol code numberMACS(Uni-Koeln-1260)
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity of Cologne
    B.1.3.4CountryGermany
    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 Exelon
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharma
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Capsule
    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 INNRivastigmine Hydrogen Tartrate
    D.3.9.1CAS number 129101-54-8
    D.3.9.2Current sponsor codeUni-Koeln-1260
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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.IMP: 2
    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 No
    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 nameN-[C-11]-Methylpiperidin-4-yl-acetate
    D.3.2Product code C11-MP4A
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN-[11C]methyl-4-piperidylacetate
    D.3.9.1CAS number 253308-68-8
    D.3.9.2Current sponsor codeUni-Koeln-1260
    D.3.9.3Other descriptive nameC11-MP4A
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number550
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product Yes
    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 Information not present in EudraCT
    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
    Patients with mild cognitive impairment (MCI) (50-80 years), who are at greater risk of developing alzheimer's dementia will be recruited in the present study and will be compared to an age-matched group of healthy subjects (50-80 years).
    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
    We want to investigate the effects of cholinergic stimulation on brain activity underlying memory in healthy older subjects and patients with mild cognitive impairment (MCI). In a double-blind, placebo-controlled crossover design we want to administer rivastigmine or placebo prior to measuring brain activity during memory paradigm using fMRI. We expect that cholinergic stimulation will enhance cognitive performance and the underlying brain activity in patients with MCI more than in healthy older controls.
    Therefore we will test whether there is a group difference between healthy subjects and MCI patients in the correlation of regional MP4A-PET activity (visualising the cerebral cholinergic system) and brain activity underlying memory and attention functions. We will furthermore investigate whether the effect of cholinergic stimulation (using rivastigmine) is dependent on the MP4A-PET activity and whether there is a group difference.
    E.2.2Secondary objectives of the trial
    Secondary objectives are the investigation of 1) group differences in MP4A-acitivity, 2) group differences in brain activity underlying memory and attention processes, 3) group differences in the effect of cholinergic stimulation on behavioral measures of memory and attention, and 4) a security analysis of rivastigmine and C11-MP4A-Application
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Healthy older subjects (aged 50-80 years) with no neurological or psychiatric diseases and normal scores in neuropsychological tests (VLMT, MMSE, BDI, Digit Span und LPS4).
    Patients with MCI (aged 50-80 years) without other neurological or psychiatric diseases. MCI will be defined as amnestic MCI with isolated memory deficits without significant effect on daily living.
    VLMT scores > 1,5 standard deviations below normal values, MMSE score > 23, normal scores in BDI, Digit Span und LPS4, normal ADL scores,
    Written and informed consent.
    Normal neurological examination.
    Normal body examination including auscultation of lung and heart as well as palpation of the abdomen.
    Normal ECG.
    Systolic blood pressure 100-160 mmHg, diastolic blood pressure 50-100 mmHg
    heart frequency 50-100.

    An equal number of men and women will be tested in order to draw valid inference from the study for the general population since it is estimated that MCI is represented in men and women to the same degree.
    E.4Principal exclusion criteria
    Neurologic or psychiatric diseases (other than MCI). Severe lung, liver, kidney or gastrointestinal tract diseases, cancer, thyreotoxicosis, drug hypersensitiviy for rivastigmine, history of contact dermatitis under transdermal rivastigmine therapy, pregnancy or breast-feeding. Bronchial asthma, gangrene, coronary heart disease, bradycardia, cardiac arrhythmia, gastric ulcers, mechanical constipation, arterial hypotension. Medication with choline esterase inhibitors, epilepsy, arterial hypotension. Medication with anticholinergic drugs.
    For the MRI part: Metal parts in or on body, tattoos, claustrophobia. With the exception of MR-compatible implants in MCI-patients.
    PET-investigation, healthy subjects: previous nuclear medicine investigations for research purposes. Hypersensitivity to MP4A.
    PET-investigation, MCI patients: previous nuclear medicine investigations for research purposes in the past 10 years, if an effective dose of 10 mSv is expected to be exceeded.
    E.5 End points
    E.5.1Primary end point(s)
    Between-group difference in the correlation between regional MP4A-activity and brain activity underlying memory and attention functions.

    Between-group difference in the effect of cholinergic stimulation on brain activity.

    Correlation of the effect of cholinergic stimulation on brain activity with regional MP4A-activity.


    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    cholinergic effects on cognitive performance and brain activity
    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 Yes
    E.7.1.3.1Other trial type description
    cholinergic effects on cognitive performance and brain activity
    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.8.3 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 Information not present in EudraCT
    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
    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 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 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.1.3Elderly (>=65 years) Yes
    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 Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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)
    Since only a single administration of rivastigmine is planned, no treatment or care after the end of the participation in the trial is planned for healthy subjects.
    MCI patients will be provided with further ambulatory care by the Department of Neurology of the University Clinic Cologne.
    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 Decision2010-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-05-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-05-07
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