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    Summary
    EudraCT Number:2004-002007-33
    Sponsor's Protocol Code Number:A2581078
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2004-10-21
    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 ConcernedAustria - BASG
    A.2EudraCT number2004-002007-33
    A.3Full title of the trial
    An 80-week, randomized, multi center, parallel group, double-blind study of the efficacy and safety of atorvastatin 80 mg plus an acetylcholinesterase inhibitor versus an acetylcholinesterase inhibitor alone in the treatment of mild to moderate Alzheimer' s disease.
    A.3.2Name or abbreviated title of the trial where available
    LEADe Lipitor's Effect on Alzheimer Dementia
    A.4.1Sponsor's protocol code numberA2581078
    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 SponsorPfizer Inc.
    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.2.1.1.1Trade name Sortis®
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Corporation Austria Ges.m.b.H.,Wien
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameSortis®
    D.3.2Product code NA
    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 INNAtorvastatin Calcium
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeNA
    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 number40
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.1.1Trade name Aricept®
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Corporation Austria Ges.m.b.H.,Wien
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameAricept®
    D.3.2Product code NA
    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 INNDonepezil Hydrochloride
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    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 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 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
    The primary objective of this study is to demonstrate the superiority of the effects of combined treatment with atorvastatin plus an acetylcholinesterase inhibitor (donepezil) to treatment with an acetylcholinesterase inhibitor (donepezil) alone on cognition and global function as assessed by the Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) and the Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change scale (ADCS-CGIC), respectively.
    E.2.2Secondary objectives of the trial
    •Demonstrate the superiority of combined atorvastatin /acetylcholinesterase inhibitor
    (donepezil) treatment to an acetylcholinesterase inhibitor (donepezil) alone on other clinical measures of AD (behavior ;general cognitive status; overall dementia severity ; daily function).
    •Seek evidence for disease modifying effects of combined atorvastatin plus an
    acetylcholinesterase inhibitor (donepezil) treatment .
    •Understand the effects of combining atorvastatin plus an acetylcholinesterase inhibitor(donepezil) versus an acetylcholinesterase inhibitor (donepezil) alone on individual cholesterol/lipid components.
    •Assess the effects of combining atorvastatin plus an acetylcholinesterase inhibitor
    (donepezil) versus an acetylcholinesterase inhibitor (donepezil) alone on caregiver burden and Patient Healthcare Resource Utilization Questionnaire.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Male and female subjects with a diagnosis of mild to moderate Alzheimer’s disease meeting all criteria listed below may be included in the study. All participants
    •Must be outpatients of any race aged between 50 and 90 years, inclusive.
    •Women must have undergone the onset of spontaneous or surgical menopause prior to the start of the study and have been amennorrheic for at least 6 months. Spontaneous menopause is defined as the natural cessation of ovarian function. Surgical menopause is defined as bilateral oophorectomy with an intact uterus.
    •Must have a Diagnostic evidence of probable Alzheimer’s disease consistent with
    NINCDS/ADRDA and DSM IV criteria (see Appendix B and C) made by the site physician at the time of Screening. This evidence must be fully documented in the subject’s source document prior to Baseline. The investigator must consider the severity of the AD to be mild to moderate and the subject to be otherwise in good health.
    •Must have a CT or MRI within the last 12 months consistent with a diagnosis of probable Alzheimer’s disease and without any other clinically significant comorbid pathologies. A copy of the report will be required and should be appended to the CRF. If there has been a significant clinical change suggestive of stroke or other possible neurological disease with onset between the time of the last CT or MRI and the Screening evaluation, the scan may be repeated with the Sponsors approval.
    MRI / MRS substudy: Subjects participating in the MRI substudy must be able to
    undergo a study-specific MRI at Baseline and at Visit 9 / Month 18 (or Early Termination if at least 9 months post-Baseline), regardless of the timing of any prior neuroimaging studies. The MRI at Baseline will also serve as the Screening MRI to support the diagnosis of probable AD (including in those subjects for whom there has been a clinical change suggesting the possibility of comorbid pathology and for whom a repeat neuroimaging scan is required). A Baseline MRI report is required only for those subjects who do not have a CT/MRI within the past 12 months of Screening. A Visit 9 / Month 18 MRI report is not required.
    •Must have a Mini-Mental Status Examination Score between 13 and 25 (inclusive) at
    screening.
    •Must have been taking a stable dose of 10 mg donepezil for > 3 months prior to screening.
    •Must have an LDL-C level > 95 mg /dl and < 195 mg/dl (2,59-2,92 mmol/L) and not
    require treatment.
    •Must have laboratory findings within normal limits or clinically insignificant at screening.
    •With a current diagnosis of diabetes must demonstrate stabilization of their disease, achieved either by insulin therapy or by diet and/ or oral hypoglycaemic agents. Subjects must have an HbA1C level <10% and a fasting serum glucose value <170 mg/dl (9.40 mmol/L) and LDL-C values >95 mg/dl and < 135 mg/dl (2.59-3.37 mmol/L)
    •Must be able to swallow oral medication (tablets).
    •Vital signs must be considered normal for age.
    •Will be without sensory (e.g., impaired hearing or vision) or motor difficulties preventing their participation in all aspects of the study.
    •Must have the same reliable caregiver or family member who agrees to accompany the subject to all scheduled visits. The caregiver must have contact at least 5 days per week with the subject for a minimum of 10 waking hours per week.
    •Undergoing putative non-prescription/ prescription cognitive enhancer therapy may be included, but such drugs should be discouraged.
    •Residing in approved assisted living facilities must be able to perform ADLs.
    E.4Principal exclusion criteria
    Subjects presenting with any of the following will not be included in the study.
    •Significant allergies to or significant intolerance of donepezil or piperidine derivatives or a known hypersensitivity to or intolerance of HMG-CoA reductase inhibitor.
    •Treatment with any cholinesterase inhibitor other than donepezil within 3 months of Screening
    •Currently on any other lipid lowering agent.
    •On lipid lowering therapy within 6 months of screening
    •A CT or MRI scan consistent with the diagnosis of stroke intracranial bleeding, mass lesion, or normal pressure hydrocephalus.
    •Dementia due to causes other than Alzheimer’s disease.
    •A current DSM-IV diagnosis of major Depressive Disorder, MDD in partial remission, or any current primary psychiatric diagnosis other than Alzheimer’s disease.
    •Evidence of current hospitalisation or residence in a skilled nursing facility
    •Dementia complicated by other organic disease or Alzheimer’s disease with delirium(DSM 290.30 or 290.11). Psychiatric symptoms (e.g., depression, anxiety, delusions) are common in AD, but subjects with pronounced severe symptoms such that they warrant an alternative concurrent diagnosis, should be excluded.
    •History or presence of seizure disorders or encephalitis.
    •Any currently clinically significant or unstable medical condition (other than Alzheimer’s disease)
    •Subjects with a history of deep venous thrombosis, pulmonary embolus or any other thrombo-embolic disorder within the last 2 years.
    •Vitamin B12 deficiency however, subjects taking a stable dose of medication for > 3 months prior to screening and who have normal B12 levels at screening will be eligible.
    •Uncontrolled hypertension (sitting diastolic BP > 95 mmHg and systolic > 160 mm Hg)
    E.5 End points
    E.5.1Primary end point(s)
    (1)Change from Baseline on the mean score of Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog).
    (2) Change from Baseline on the mean score of Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC).
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    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) 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) Yes
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months4
    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 state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 380
    F.4.2.2In the whole clinical trial 600
    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 Decision2004-11-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-11-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-07-11
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