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    Summary
    EudraCT Number:2004-003435-31
    Sponsor's Protocol Code Number:CL-758010
    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:2005-10-11
    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 number2004-003435-31
    A.3Full title of the trial
    A Phase III Study of the Efficacy and Safety of Alzhemed™ as Add-on Therapy in Mild to Moderate Alzheimer's Disease Patients.
    A.4.1Sponsor's protocol code numberCL-758010
    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 nameHomotaurine
    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.3.9.1CAS number 3687-18-1
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    Alzheimer’s Disease (AD) is an irreversible, progressive neuro-degenartive disorder, characterized by gradual cognitive deficits associated with abnormal behaviour, personality changes, and which ultimately leads to dementia.
    Cerebral amyloid angiopathy (CAA) has also been found to be particularly common in Alzheimer patients.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    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 study is to assess the efficacy and safety of Alzhemed™ in patients with mild to moderate Alzheimer’s disease (AD). Symptomatic efficacy will be assessed by comparing Alzhemed™ versus placebo using the Alzheimer’s Disease Assessment Scale, cognitive subscale (ADAS-cog) for evaluating global cognitive functioning and the Clinical Dementia Rating Sum of Boxes (CDR-SB) for evaluating global clinical status. The disease modifying effect of Alzhemed™ will be assessed by comparing the rates of change (i.e. difference in slopes) in the ADAS-cog scores of the Alzhemed™ vs. placebo groups over the duration of the trial.
    E.2.2Secondary objectives of the trial
    •Evaluate Alzhemed™ effect on cognitive decline prior to week 78 using the ADAS-cog and Mini Mental State Examination (MMSE) scales.
    •Evaluate overall clinical response to Alzhemed™ prior to week 78 using the CDR-SB and Clinical Interview Based Impression of Change-Plus (CIBIC-plus) scales.
    •Evaluate Alzhemed™ effect on the emergence of neuropsychiatric symptoms using the NeuroPsychiatric Inventory (NPI) scale.
    •Evaluate Alzhemed™effect on functional decline using the Disability Assessment for Dementia (DAD) scale.
    •Evaluate Alzhemed™ effect on hippocampal, whole brain and entorhinal cortex atrophy using Magnetic Resonance Imaging in a subset of the cohort.
    •Measure Alzhemed™ effect on amyloid-beta levels in plasma, CSF and urine in a subset of the cohort.
    •Measure Alzhemed™ effect on tau protein levels in the CSF in a subset of the cohort.
    •Characterize the population pharmacokinetics of Alzhemed™ in patients with AD.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    •Evaluate Alzhemed™ effect on hippocampal, whole brain and entorhinal cortex atrophy using Magnetic Resonance Imaging in a subset of the cohort.
    •Measure Alzhemed™ effect on amyloid-beta levels in plasma, CSF and urine in a subset of the cohort.
    •Measure Alzhemed™ effect on tau protein levels in the CSF in a subset of the cohort.
    E.3Principal inclusion criteria
    1) Potential participants must be 50 years of age or older.
    2) Female subjects must be of non-childbearing potential (i.e. surgically sterilized or at least 2 years post-menopausal). All subjects must agree to ensure that appropriate contraceptive measures will be taken during the course of the study.
    3) Diagnosis of dementia based on the Diagnostic and Statistical Manual, 4th edition
    (DSM-IV) criteria
    4) Diagnosis of probable AD based on the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer’s Disease and Related Disorders Association (NINCDS-ADRDA criteria)
    5) Severity of dementia of mild to moderate degree as reflected by a score of 16-26 (inclusive) on the MMSE performed at the screening visit.
    6) The potential participant must be living in a community with a reliable caregiver that will attend each clinic visit, complete required evaluations, supervise and ensure that all doses of medication are administered appropriately during the entire study. A reliable caregiver is an individual who has daily contacts (including visits and/or phone calls) with the participant. For consistency, it is recommended to have the same caregiver accompanying the participant at each visit. Participants living in assisted living facilities may be included in the study as long as the study medication intake is supervised and the participant has a reliable caregiver. Due to the length of this study, it is highly recommended to identify other potential caregivers during the screening evaluation.
    7) 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 procedures.
    8) The potential participant must have a Geriatric Depression Scale (GDS) result of <10.
    9) The potential participant must be treated with an AChEI (i.e., donepezil, galantamine or rivastigmine) and must be on a stable therapeutic dose regimen for at least 4 months prior to the screening visit and during the entire study.
    10) The potential participant treated with one of the following medications must be on stable doses for at least 1 month prior to the screening visit and during the entire study: anxiolytics, sedatives, hypnotics, antidepressants, antipsychotics, anticonvulsants, estrogens and statins.
    11) The potential participant on vitamin E should not have an intake of more than 2050 IU/day for at least 1 month prior to the screening visit and during the entire study.
    12) If the potential participant has any other clinically significant medical condition (other than AD), it has to be stable for at least 3 months prior to the screening visit.
    13) The following screening tests must be within normal limits or determined as not clinically significant by the study physician for participant’s sex and age:
    a. Routine 12-lead electrocardiogram (ECG),
    b. Cranial computerized tomography (CT) or Magnetic resonance imaging (MRI) scan performed within 2 years prior to the end of the screening period and after the onset of AD symptoms.
    c. Clinical laboratory test battery
    14) Fluency (oral and written) in the language in which the standardized tests will be administered.
    15) Signed informed consent from potential participant or legal representative and caregiver.
    E.4Principal exclusion criteria
    1) Potential participants with any other cause of dementia as evidenced by medical history, general physical and neurological examination, laboratory tests, and neuro-radiological findings.
    2) Acquired immune deficiency syndrome (AIDS) positive through medical history or HIV positive.
    3) Allergy and/or hypersensitivity to any component of the study medication.
    4) Life expectancy less than 2 years.
    5) History or current evidence of seizure disorder or convulsions.
    6) History of drug or alcohol abuse within the previous 5 years or prior prolonged history.
    7) Current evidence or history within the past 2 years of myocardial infarction, congestive heart failure (greater than class 1 of the NYHA guidelines), cerebrovascular accident and/or transient ischemic attack.
    8) Potential participant with a clinically significant and/or uncontrolled cardiovascular, renal, hepatic, pulmonary (including severe asthma), gastrointestinal, endocrine, metabolic, ophthalmologic, immunologic or hematologic condition or other significant medical disease.
    9) Presence of any clinical condition that might interfere with the interpretation of efficacy and safety results.
    10) The presence of a significant nutritional deficiency, as assessed by the Mini Nutritional Assessment (MNA), as defined by a MNA score of less than 17.
    11) Any condition that can significantly affect the absorption of the study medication.
    12) ALT, ALP or AST > 2 times the upper limit of normal ranges and total bilirubin > 2 times the upper limit of normal.
    13) Clinically significant deficiency in serum vitamin B12 or folate.
    14) Use of memantine in the 4 months prior to the screening visit and during the course of the study.
    15) Previous use of an investigational anti-amyloid or vaccine treatment for AD.
    16) Participation in another drug trial within 30 days prior to the screening visit or during the study.
    17) Potential participant has had previous exposure to Alzhemed™.
    18) Any medical condition/device that might interfere with the performance of the MRI (MRI subset only).
    19) Any medical condition and/or medication that might interfere with the lumbar puncture procedure (LP subset only).
    20) Inability of participant or legal representative and caregiver to provide a signed informed consent form.
    21) Inability to swallow medication tablets.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoints to assess symptomatic effects will be the changes from baseline to Week 78 in ADAS-cog and CDR-SB scores. Disease modification effects will then be assessed by comparing the rate of change (differences in slopes) in ADAS-cog scores between Alzhemed™ and placebo groups.
    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 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.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA75
    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 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
    The end of the clinical trial will be the completion of the Follow up visit during which clinical safety assessments will be performed.
    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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    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 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 state75
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 930
    F.4.2.2In the whole clinical trial 930
    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)
    The study sponsor is also planning to design an open label extension study, where all patients who will have completed the study as per protocol will be offered Alzhemed™.
    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 Decision2005-11-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-11-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2007-12-14
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