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    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2021-001788-26
    Sponsor's Protocol Code Number:APHP201183
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-05-12
    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 ConcernedFrance - ANSM
    A.2EudraCT number2021-001788-26
    A.3Full title of the trial
    Interest of adding donepezil to the non-medicinal care pathway recommended in France for Alzheimer's disease: CHOLINE-2 study
    Intérêt de l’adjonction du donepezil à la prise en charge non médicamenteuse par parcours de soin préconisée en France dans la maladie d’Alzheimer: Etude CHOLINE-2
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Interest of adding donepezil to the non-medicinal care pathway recommended in France for Alzheimer's disease: CHOLINE-2 study
    Intérêt de l’adjonction du donepezil à la prise en charge non médicamenteuse par parcours de soin préconisée en France dans la maladie d’Alzheimer: Etude CHOLINE-2
    A.3.2Name or abbreviated title of the trial where available
    CHOLINE-2
    CHOLINE-2
    A.4.1Sponsor's protocol code numberAPHP201183
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAssistance Publique - Hôpitaux de Paris
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportASSOCIATION FRANCE ALZHEIMER ET MALADIES APPARENTEES
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAssistance Publique - Hôpitaux de Paris
    B.5.2Functional name of contact pointElodie SOLEr
    B.5.3 Address:
    B.5.3.1Street AddressHôpital Saint-Louis, 1 avenue Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number+33(0)1 44 84 17 35
    B.5.5Fax number+33(0)1 44 84 17 01
    B.5.6E-mailelodie.soler@aphp.fr
    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 Yes
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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.3.9.1CAS number 120014-06-4
    D.3.9.4EV Substance CodeSUB06362MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 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 Yes
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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.3.9.1CAS number 120014-06-4
    D.3.9.4EV Substance CodeSUB06362MIG
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    Newly diagnosed patient with mild to moderate Alzheimer's disease meeting IWG-2 research diagnostic criteria including positivity for Alzheimer's disease biomarkers.
    Patient nouvellement diagnostiqué pour une maladie d’Alzheimer à un stade léger ou modéré répondant aux critères diagnostiques de recherche IWG-2 incluant la positivité des biomarqueurs de la maladie d’Alzheimer.
    E.1.1.1Medical condition in easily understood language
    Alzheimer's disease
    Maladie d’Alzheimer
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    E.1.2System Organ Class 100000004852
    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 cognitive efficiency at 6 months of daily intake of donepezil compared to the usual non-drug management by course of treatment.
    Evaluer l’efficacité cognitive à 6 mois de la prise quotidienne de donepezil comparativement à la prise en charge usuelle non médicamenteuse par parcours de soin.
    E.2.2Secondary objectives of the trial
    Efficacy at 6 months on the different clinical scales used: ADAS-Cog, CDR, ADCS-ADL, quality of life, ZARIT.
    - Efficacité à 6 mois sur les différentes échelles cliniques utilisées : ADAS-Cog, CDR, ADCS-ADL, qualité de vie, ZARIT.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Diagnosis of Alzheimer's disease according to the 2014 IWG-2 criteria.
    - Covered by social security.
    - Age ≥ 50 years old.
    - Lack of legal protection measure (guardianship, curatorship).
    - MMSE score ≥ 10 on inclusion.
    - Aβ42 in the CSF or abnormal Aβ40 / Aβ42 ratio according to the local cut-offs of the different centers.
    - Phosphorylated tau in the CSF abnormal according to the local cut-offs of the different centers.
    - Presence of a family companion or a person at home who can ensure compliance with treatment in the event of an MMSE score <20.
    - Sufficient command of the French language for the taking of neuropsychological tests.
    - Diagnostic de maladie d’Alzheimer selon les critères IWG-2 de 2014.
    - Prise en charge par la sécurité sociale.
    - Age ≥ 50 ans.
    - Absence de mesure de protection juridique (tutelle, curatelle).
    - Score MMSE ≥ 10 à l’inclusion.
    - Aβ42 dans le LCR ou ratio Aβ40/Aβ42 anormales selon les cut-offs locaux des différents centres.
    - Tau phosphorylé dans le LCR anormale selon les cut-offs locaux des différents centres.
    - Présence d’un accompagnant familial ou d’une personne au domicile pouvant s’assurer de la compliance au traitement en cas de score MMSE < 20.
    -Maitrise suffisante de la langue française pour la passation des tests neuropsychologiques.
    E.4Principal exclusion criteria
    - Another cause of major neurocognitive disorder.
    - Cardiological contraindication after possible opinion of a cardiologist, at the initiative of the investigator, in particular bradycardia, presence of 2nd or 3rd degree atrioventricular block.
    - Previous treatment of symptomatic Alzheimer's disease.
    - Participation in another intervention research
    - Autre cause de trouble neurocognitif majeur.
    - Contre-indication cardiologique après éventuel avis d’un cardiologue, à l’initiative de l’investigateur, notamment bradycardie, présence d’un bloc auriculo-ventriculaire de 2e ou 3e degré.
    - Prise antérieure d’un traitement symptomatique de la maladie d’Alzheimer.
    - Participation à une autre recherche interventionnelle
    E.5 End points
    E.5.1Primary end point(s)
    Difference in MMSE score between inclusion and 6 months, in the arm treated with donepezil and the usual course of care arm.
    Différence du score MMSE entre l’inclusion et 6 mois, dans le bras traité par donepezil et le bras parcours de soin usuel.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    6 mois
    E.5.2Secondary end point(s)
    - Difference at 6 months in scores, ADAS-Cog, CDR, ADCS-ADL, quality of life, ZARIT.
    - Différence à 6 mois des scores, ADAS-Cog, CDR, ADCS-ADL, qualité de vie, ZARIT.
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months
    6 mois
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Parcours de soin non médicamenteux
    Non-drug treatment course
    E.8.2.4Number of treatment arms in the trial2
    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 concerned6
    E.8.5The trial involves multiple Member States No
    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 No
    E.8.7Trial has a data monitoring committee No
    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
    LVLS
    DVDS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months30
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state120
    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)
    None
    Aucun
    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 Decision2021-07-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-25
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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