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    Summary
    EudraCT Number:2007-004489-41
    Sponsor's Protocol Code Number:MRZ 90001-0716/1
    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:2007-11-16
    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 number2007-004489-41
    A.3Full title of the trial
    Prospective, single-arm, multi-center, open-label study to investigate the potential to reduce concomitant antipsychotics use in subjects with moderate dementia of Alzheimer’s type [DAT] treated with memantine
    A.3.2Name or abbreviated title of the trial where available
    MemAP
    A.4.1Sponsor's protocol code numberMRZ 90001-0716/1
    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 SponsorMerz Pharmaceuticals GmbH
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 Axura
    D.2.1.1.2Name of the Marketing Authorisation holderMerz Pharmaceuticals GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameAxura
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNmemantine hydrochloride
    D.3.9.1CAS number 41100-52-1
    D.3.9.3Other descriptive name3,5-dimethyl-1-adamantanamine hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Dementia of Alzheimer’s Type [DAT] in subjects with Mini Mental State Examination [MMSE] score 10-19 and Global Deterioration Scale [GDS] score 3-5 and antipsychotics medication during the last 3 months (at least intake at 5 days/week)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 10.1
    E.1.2Level LLT
    E.1.2Classification code 10012271
    E.1.2Term <Manually entered code. Term in E.1.1>
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The study objective is to assess the potential of reducing the use of antipsychotics in subjects with moderate DAT, treated de novo with memantine.
    E.2.2Secondary objectives of the trial
    The secondary efficacy objectives concern the assessment of safety parameters, the impact of memantine and antipsychotics on measures of cognitive functions, behavior, and activities of daily living.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Current diagnosis of probable AD consistent with NINCDS-ADRDA criteria and with DSM IV TR criteria for DAT (precised in Appendices B and C)
    - Treatment with typical or atypical antipsychotic medication for at least 5 days/week during the last 3 months prior to the screening visit
    - If DAT treated with a cholinesterase inhibitor, treatment with a stable dose during the 3 months preceding the screening visit
    - MMSE score of 10-19 / GDS score of 3-5
    - Signed informed consent prior to the initiation of any study specific procedures
    - Male or female of age ≥ 50 years and <85 years
    - The subject speaks German as a mother tongue or at least speaks German fluently in order to comply with the study requirements
    - MRI or CT scan supporting the diagnosis of DAT without indications of any relevant other CNS disorders
    - Sufficient sight and hearing (a hearing aid is permitted) to enable the performance of study-related procedures and psychometric tests
    - In the investigator’s opinion, the subject will be capable of completing all study-related activities
    - If female, subject is at least 2 years post menopausal or surgically sterile
    E.4Principal exclusion criteria
    - Previous or current treatment with memantine or participation in an investigational study with memantine
    - Treatment with depot antipsychotics
    - Treatment with more than 2 antipsychotic drugs at the time of study entry and during 3 months prior to the screening visit
    - Intake of any medication that is contra-indicated in combination with memantine (precised in SmPC)
    - Evidence of clinically significant and active pulmonary, gastrointestinal, renal, hepatic, endocrine or cardiovascular system disease (Note, subjects with controlled diabetes and hypertension can be included, provided they do not use unauthorized concomitant medication)
    - Within 3 months prior to screening clinically significant or currently untreated B12, TSH or folate deficiency (subjects with thyroid disease can be included in the study, provided they are stable and euthyroid)
    - History of severe drug allergy, or hypersensitivity, or known hypersensitivity to amantadine and lactose
    - Evidence (including CT/MRI results) of any clinically significant CNS disease other than AD, especially other types of dementia (e.g. vascular type dementia, Lewy-body disease, etc.)
    - Modified Hachinski Ischemia score > 4 at screening (precised in Appendix D)
    - Current evidence of clinically significant unstable psychiatric illness (other than symptoms associated with AD) including bipolar or unipolar depression
    - Lifetime diagnosis of psychotic disorder other than symptoms associated with AD
    - Cancerous disease (hematological or solid tumor), which is currently under treatment or evidence of active disease
    - Known or suspected history of alcoholism or drug abuse within the past 2 years
    - Participation in another clinical study for an investigational medicinal product within the previous 90 days (or 5 half-lives of the investigational medicinal product, whichever is longer) prior to the screening visit or during the study
    - Any disease or medical treatment that can interfere with the assessment of safety, tolerability or efficacy, according to the investigator’s judgment
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the maximum dose reduction of antipsychotics from baseline to a post-baseline visit in week 8, 12, 16 or 20, at which the value of the VAS is not substantially worse, compared with the baseline value. Substantially worse is defined a a deterioration of 15 % on the VAS.

    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned25
    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
    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 months
    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.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients with moderate Alzheimer's disease - possible contractual disability in individual cases
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state144
    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 Decision2007-12-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-02-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-06-23
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