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    Summary
    EudraCT Number:2004-004918-17
    Sponsor's Protocol Code Number:A2501046
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-02-25
    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 ConcernedFinland - Fimea
    A.2EudraCT number2004-004918-17
    A.3Full title of the trial
    A 12-week, open label, multicentre study assessing the efficcay and of Donepezil in patients discontinuing treatment with Memantine monotherapy
    A.4.1Sponsor's protocol code numberA2501046
    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 Aricept
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Oy
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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 (donepezil hydrochloride)
    D.3.2Product code E2020
    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 INNdonepezil
    D.3.9.2Current sponsor codeE2020
    D.3.9.3Other descriptive name2.3-dihydro-5,6-dimethoxy-2-{[1-(phenylmethyl)-4-piperidinyl] methyl}-1H-inden-1-one hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number5 to 10
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Alzheimer's disease
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7
    E.1.2Level VTc
    E.1.2Classification code 10012271
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of donepezil on cognition (MMSE) in patients who are currently being treated with memantine, and are switched to donepezil because treatment with memantine is lacking efficacy or is not well tolerated
    E.2.2Secondary objectives of the trial
    To evaluate the effects of donepezil on other clinically relevant measures including behaviour (NPI), physician and caregiver satisfaction/ease of use, global function (CGI-I), social behaviour (Caregiver Diary), safety and tolerability in this patient group.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Patients aged 50 years or over, both men and women. Women of childbearing potential or <2 year post-menopausal must be practising an approved method of contraception and have negative serum b-HCG at screening (women who are breastfeeding are excluded).
    Written informed consent to participation.
    Patients with moderate to severe Alzheimer’s disease with an MMSE score between 5-17 (inclusive).
    Diagnostic evidence of probable or possible Alzheimer’s disease consistent with DSM-IV and NINCDS-ADRDA criteria made by the site physician at the time of the screening visit. This evidence must be fully documented in the patient’s file prior to the baseline visit.
    CT or MRI within the last 18 months consistent with a diagnosis of Alzheimer’s disease without any other clinically significant co-morbid pathologies found. If there has been a significant change in clinical status 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 should be repeated if considered appropriate by the investigator.
    The patient must be capable of completing all procedures scheduled during the screening and baseline visits including all efficacy parameters (i.e. psychometric tests).
    Patients must have a reliable caregiver or family member who agrees to accompany the patient to all clinic visits, provide information about the patient as required by the protocol, and ensure compliance with the medication schedule.
    The patient must be currently taking memantine at the recommended dose (10 mg bid) for at least 3 months prior to the screening visit and maintained until the baseline visit.
    Treatment of the patient with memantine is judged by the clinician at the time of screening as lacking efficacy or not well tolerated.
    Clinical laboratory values within normal limits, and within the sponsor’s guidelines, or, if abnormal, considered and documented as not clinically significant by the investigator.
    Health: otherwise healthy and ambulatory or ambulatory-aided (i.e., walker, cane or wheelchair). Vision and hearing (eyeglasses and/or hearing aid permissible) sufficient for compliance with testing procedures.
    Patients with stable insulin-dependent diabetes or diabetes stabilized by diet and/or oral hypoglycaemic agents are eligible provided they are monitored regularly to ensure adequacy of control. Patients with known diabetes should have an HbA1C of < 10% at screening.
    Patients with controlled hypertension (sitting diastolic BP < 95 mmHg), right bundle branch block (complete or partial), and pacemakers may be included in the study.
    Patients with thyroid disease may also be included in the study provided they are euthyroid and stable on treatment for at least 3 months prior to screening. Stable treatment must be maintained throughout the study.
    Patients with vitamin B12 deficiency who are on a stable dose of medication for at least 3 months prior to screening, and who have normal serum B12 levels at screening, will be eligible. This stable dose must be maintained throughout the study.
    E.4Principal exclusion criteria
    Patients with a known hypersensitivity to donepezil, piperidine derivatives, or any of the excipients used in the formulation of donepezil
    Patients with active or clinically significant conditions affecting absorption, distribution or metabolism of the study medication.
    Patients who have been treated with a cholinesterase inhibitor in the 3 months prior to screening visit.
    Patients treated with any investigational drug within 30 days of screening visit.
    Patients without a reliable caregiver, or patients or caregivers who are unwilling or unable to complete any of the outcome measures and fulfill the requirements of this study.
    Nursing home patients will be excluded from entering the study. Likewise, patients for whom institutionalization is being considered within the next 3 months should also be excluded.
    Patients with clinically significant obstructive pulmonary disease or asthma.
    Patients with a recent (< 2 years) haematologic/oncologic disorders.
    Evidence of active clinically significant and unstable gastrointestinal, endocrine or cardiovascular system disease.
    Evidence of severe hepatic or renal impairment.
    Patients with a current DSM-lV diagnosis of Major Depressive Disorder (MDD), or any current primary psychiatric diagnosis other than Alzheimer’s disease (as per DSM-lV). Patients who, in the judgment of the investigator, represent a suicide risk.
    Patients with dementia complicated by other organic disease or Alzheimer’s disease with delirium (DSM 290.30 or 290.11) are excluded. Depression or delusions are common in Alzheimer’s disease, but patients with pronounced severe symptoms such that they warrant an alternative concurrent diagnosis, should be excluded.
    Patients with a known or suspected history of alcoholism or drug abuse (within the past 10 years).
    Any condition which would make the patient or the caregiver, in the opinion of the investigator or sponsor, unsuitable for the study.
    Patients who have taken or are taking any unapproved prior or concomitant medication as defined in the protocol.
    Patients with a history of seizures or seizure disorders.
    Patients must be able to swallow tablet medication. No crushing of tablets is allowed.
    E.5 End points
    E.5.1Primary end point(s)
    Mini Mental State Examination (MMSE): The MMSE is a brief test to assess the cognitive status of the patient. The 30-point test includes items that evaluate orientation to time and place, immediate and delayed recall, attention and language. The MMSE will be administered by the same trained rater at each visit.
    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 No
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    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 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 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 years1
    E.8.9.1In the Member State concerned months0
    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 months0
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-02-25. Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Severely demented patients, who may consent via legal representative or carer
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    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 Decision2005-04-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-03-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-07-17
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