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    Summary
    EudraCT Number:2006-002317-12
    Sponsor's Protocol Code Number:ACT10019
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-06-22
    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 ConcernedSweden - MPA
    A.2EudraCT number2006-002317-12
    A.3Full title of the trial
    A double-blind placebo-controlled study of the activity of AVE1625 at doses of 10 mg and 40mg for 12 weeks in patients with mild to moderate Alzheimer's Disease
    A.3.2Name or abbreviated title of the trial where available
    NA
    A.4.1Sponsor's protocol code numberACT10019
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberNA
    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 SponsorSanofi-aventis
    B.1.3.4CountryUnited States
    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 Information not present in EudraCT
    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 nameAVE1625
    D.3.2Product code AVE1625
    D.3.4Pharmaceutical form Capsule, soft
    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 INNNA
    D.3.9.1CAS number 358970-97-5
    D.3.9.2Current sponsor codeAVE1625
    D.3.9.3Other descriptive nameNA
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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, soft
    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
    Mild to moderate Alzheimer Disease
    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 assess the activity of AVE1625 at the doses of 10 and 40 mg/day in comparison to placebo in patients with mild to moderate Alzheimer Disease:
    - Safety and tolerability by monitoring of adverse events, clinical laboratories, and ECG
    - Efficacy by evaluation of cognitive, global, and behavioral parameters
    E.2.2Secondary objectives of the trial
    To evaluate the pharmacokinetic parameters of AVE1625 in patients with mild to moderate Alzheimer Disease
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1- The diagnosis of AD based on: the DAT DSM-IV criteria and the NINCDS/ADRDA criteria for Probable AD.

    2- The diagnosis should also be supported by: a Modified Hachinski score < 4 and a CT scan/MRI of the brain performed within 12 months prior to randomization that is consistent with the diagnosis of AD. If a patient is followed at the investigational center, had a previous CT scan / MRI scan (older than 12 months) and has had no focal clinical changes then no new imaging is necessary.

    3- Mild to moderate range of severity established by a Mini-Mental State Examination (MMSE) score ≥ 12 and ≤ 26 at screening.
    E.4Principal exclusion criteria
    1. < 50 years of age

    2. Severe or unstable cardiovascular, respiratory, renal, hepatic, hematological, endocrinological, neurological or other somatic disease evidenced by history, physical examination, ECG or laboratory tests, which may interfere with the study in the investigator’s judgment (through interference with the evaluation of the study drug or with the absorption, metabolism or excretion of the study medication). In addition to those abnormalities which in the investigator’s judgment are severe or unstable, the following alterations of laboratory tests / ECG findings on the screening must lead to exclusion of the patients: (a) ALT or AST > five times the upper limits of the reference range; (b) serum creatinine > 150 µmol / L; (c) neutrophils < 1,500/mm3 , and (d) QTc > 500 ms.

    3. Evidence of any other primary central nervous system condition (such as but not limited to Parkinson’s disease, Multi-infarct dementia, or other dementias)
    4. Epilepsy
    5. Current symptoms of depression at screening, (patients on therapy, if stable for at least 3 months before randomization, with no significant symptoms, are allowed to be included).
    6. Evidence of other primary psychiatric condition, which may interfere with the study in the investigator’s judgment

    7. Females of childbearing potential. Females of child bearing potential are defined as females who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, bilateral oopherectomy) or are not postmenopausal

    8. Potent CYP3A4 inhibitors (ritonavir, itraconaxole, nefazodone, ketoconazole, clarithromycin, telithromycin, troleandomycin, chloramphenicol, cyclosporine, grapefruit juice).
    9. Potent CYP2C19 inhibitors (fluvoxamine) and fluconazole.
    10. Use of CYP2C9 substrates (sulfonylureas, glitazones, nateglinide, warfarin, losartan, irbesartan, fluvastatin, amytriptiline, fluoxetine, phenytoin, tamoxifen, leflunomid, acenocoumarol, phenprocoumon, hexobarbital, celecoxib)

    11. Patients with any of the following: history or presence of blood dyscrasia and bleeding disorder including thrombocytopenia, thrombopathy, hypofibrinogenemia, hemophilia, anemia or known protein S or C deficiency; active or recent (within 3 months of randomization) significant bleeding, including gastrointestinal bleeding or peptic ulcer; laboratory coagulation parameters out of normal ranges: INR (>1.2); or use of anticoagulants or recent treatment with thrombolytic agents

    12. Treatment with memantine
    13. If treated with a cholinesterase inhibitor any change in therapy or dose in the 3 months prior to randomization
    14. If previously treated with an approved theraphy for AD, but not currently treated, any change in therapy in the previous 3 months prior to randomization
    15. Recent changes in treatment with atypical antipsychotics (such as clozapine, olanzapine, risperidone, ziprasidone) or expectations of changes during the duration of the study. In general these treatments should have been in use and well tolerated for 3 months prior to randomization with no change in dose in the 3 months prior to randomization.
    16. Treatment with typical antipsychotics, tricyclic antidepressants or MAOI antidepressants. If previously administered, the patient should have stopped taking these drugs at least 4 weeks prior to randomization.

    17. Participation in another clinical trial with an investigational drug or other investigational intervention within two months prior to randomization or with an investigational drug with a pharmacokinetic profile that would lead to the possibility that the drug was not fully eliminated

    18. Inpatient in a total care facility (e.g.: Nursing home)
    19. Lack of reliable caregiver; who has contact with the patient at least 4 hours per day for 4 days per week or 2 hours per day for 7 days per week
    20. Refusal or inability to give informed consent to participate in the study: patient, identified caregiver and, if applicable, patient surrogate (primary relative, legal guardian, medical proxy) must give their informed written consent and are capable of following study procedures
    E.5 End points
    E.5.1Primary end point(s)
    Safety and tolerability: Safety variables include the percentage of patients withdrawn from study drug due to an adverse event, reported adverse events, clinical laboratory values, ECG, neurological evaluation, and vital signs.
    Adverse events will be collected by spontaneous report, physical examination and neurological assessment, vital sign monitoring, clinical laboratories, and ECG’s.
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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 Information not present in EudraCT
    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 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.8.3 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.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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 patient , last visit
    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
    E.8.9.2In all countries concerned by the trial years1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 150
    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)
    NA
    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 Decision2006-08-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-07-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-07-12
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