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    Summary
    EudraCT Number:2006-006490-24
    Sponsor's Protocol Code Number:CL-758019
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-04-02
    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 ConcernedSweden - MPA
    A.2EudraCT number2006-006490-24
    A.3Full title of the trial
    An Open-Label Extension of the Phase III Study CL-758010 with Alzhemed™ in Patients with Alzheimer’s Disease.
    A.4.1Sponsor's protocol code numberCL-758019
    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 SponsorNeurochem Inc
    B.1.3.4CountryCanada
    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 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 nameAlzhemed™
    D.3.2Product code NC-758
    D.3.4Pharmaceutical form 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 INNTramiprosate
    D.3.9.1CAS number 3687-18-1
    D.3.9.2Current sponsor codeNC-758
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Alzheimer's Disease (AD) is an irreversible, progressive neurodegenerative disorder, characterized by gradual cognitive decline, abnormal behaviour, and personality changes.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this open-label study is to evaluate the long-term safety of Alzhemed™ in patients with Alzheimer’s Disease (AD).
    E.2.2Secondary objectives of the trial
    • Assess the long-term effect of Alzhemed™ on global cognitive functioning using the AD Assessment Scale, cognitive subscale (ADAS-cog) and the Mini Mental State Examination (MMSE) scale.
    • Assess the long-term effect of Alzhemed™ on global clinical status using the Clinical Dementia Rating Sum of Boxes (CDR-SB).
    • Assess the effect of a delay in the initiation of Alzhemed™ treatment on global cognitive functioning using the ADAS-cog and MMSE scales.
    • Assess the effect of a delay in initiation of Alzhemed™ treatment on global clinical status using the CDR-SB.
    • Assess the long-term effect of Alzhemed™ treatment on patterns of health care resource utilization using the RUD Lite© instrument.
    • Assess the effect of a delay in initiation of Alzhemed™ treatment on patterns of health care resource utilization using the RUD Lite© instrument.
    • Assess changes in cognitive functioning and clinical status according to disease severity.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) The patient must have completed the 78-week treatment period of the double-blind CL-758010 study.
    2) Female patients must be of non-childbearing potential (i.e. surgically sterilized or at least two years post-menopausal).
    3) Male subjects who are sexually active must:
    a. Be proven to be sterile e.g. vasectomy or;
    b. Use appropriate contraceptive barrier methods, e.g. a condom.
    For the latter, in the event where the participant cannot reliably use/or is unable to use contraceptive barriers, his partner (if of childbearing potential) should be instructed to use appropriate contraceptive devices or methods to avoid pregnancy.
    4) The patient must be living in a community with a reliable caregiver that will be attending each clinic visit, completing required evaluations, supervising and ensuring the administration of all doses of medication during the entire study. A reliable caregiver is an individual who has daily contacts with the patient (e.g. visits and/or phone calls). For consistency, it is recommended to have the same caregiver accompanying the patient at each visit. Patients living in assisted living facilities may be included in the study as long as the study medication intake is supervised and that the patient has a reliable caregiver. Due to the length of this study, it is highly recommended to identify other potential caregivers during the screening evaluation.
    5) There must be signed informed consent from the patient or legal representative and the caregiver.
    6) The potential participant must be able to perform the required psychometric tests and evaluations. Visual and auditory acuity (with glasses or hearing aid, if required) must be sufficient to complete the protocol-specified measures.
    E.4Principal exclusion criteria
    1) The patient has acquired immune deficiency syndrome (AIDS) or is positive for the human immunodeficiency virus (HIV), as revealed through medical history.
    2) The patient has an allergy and/or hypersensitivity to any component of the study medication.
    3) The patient has a history of drug or alcohol abuse within the previous five years.
    4) The patient has a clinically significant and/or uncontrolled medical condition that, in the opinion of the treating physician, would pose a safety risk if the patient continued taking the study medication.
    5) The presence of a significant nutritional deficiency, as defined by a Mini Nutritional Assessment (MNA) score of less than 17.
    6) The patient has a clinical condition that might interfere with the interpretation of safety results.
    7) The patient has a condition that can significantly affect the absorption of the study medication.
    8) The patient participates in another trial during the study.
    9) The patient is unable to swallow medication tablets.
    10) The patient is otherwise unsuitable for this type of trial as determined by the treating physician.
    E.5 End points
    E.5.1Primary end point(s)
    Safety Measures
    • Adverse event assessments
    • Clinical laboratory parameters
    • Vital signs/physical examinations/electrocardiograms
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    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) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Yes
    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 Information not present in EudraCT
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA66
    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 Yes
    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 years3
    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 years3
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state85
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 640
    F.4.2.2In the whole clinical trial 650
    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)
    OLE patients will be treated with Alzhemed for the duration of the OLE study (78 weeks). Neurochem currently does not have plans to treat patients with Alzhemed after week 78 of the OLE study. If the drug is not approved patients will be treated per standard medical practice for their condition after week 78 of the OLE study.
    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 Decision2007-05-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-04-25
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2007-11-08
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