Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-001025-31
    Sponsor's Protocol Code Number:2019PI255
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-05-25
    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 number2020-001025-31
    A.3Full title of the trial
    HIGHLIGHTING THE BENEFITS OF THERAPEUTIC GARDENS IN ALZHEIMER'S DISEASE with 18F-FDG Cerebral PET / CT
    MISE EN EVIDENCE DES BENEFICES DES JARDINS THERAPEUTIQUES DANS LA MALADIE D’ALZHEIMER par une TEP/TDM CEREBRALE AU 18F-FDG
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Highlighting the benefits of walking sessions in a therapeutic garden in patients with Alzheimer's disease by PET / CT imaging of the brain with a radiopharmaceutical: 18F-FDG
    Mise en évidence des bénéfices de séances de promenades dans un jardin thérapeutique chez des patients atteints d'une maladie d'alzheimer par une imagerie TEP/TDM du cerveau avec un radiopharmaceutique : le 18F-FDG
    A.3.2Name or abbreviated title of the trial where available
    JAZTEP study
    JAZTEP
    A.4.1Sponsor's protocol code number2019PI255
    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 SponsorCHRU Nancy
    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 supportCHRU Nancy
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHRU Nancy
    B.5.2Functional name of contact pointAnne-Sophie Hue
    B.5.3 Address:
    B.5.3.1Street Address5 rue Morvan
    B.5.3.2Town/ cityVandoeuvre les Nancy
    B.5.3.3Post code54511
    B.5.3.4CountryFrance
    B.5.4Telephone number330338153475
    B.5.5Fax number330383157451
    B.5.6E-maildripromoteur@chru-nancy.fr
    D. IMP Identification
    D.IMP: 1
    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 Yes
    D.2.1.1.1Trade name FLUCIS
    D.2.1.1.2Name of the Marketing Authorisation holderCIS BIO INTERNATIONAL
    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.3.1Product nameFLUCIS
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 Yes
    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 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 Yes
    D.2.1.1.1Trade name GLUCOTEP
    D.2.1.1.2Name of the Marketing Authorisation holderLABORATOIRES CYCLOPHARMA S.A.
    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.3.1Product nameGLUCOTEP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 Yes
    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
    atients followed at the Memory and Research Center (CMRR) and diagnosed with mild to moderate Alzheimer's disease (MMS 15-23)
    Patients suivis au Centre Mémoire de Ressources et de Recherche (CMRR) et diagnostiqués maladie d'Alzheimer au stade léger à modéré (MMS 15-23).
    E.1.1.1Medical condition in easily understood language
    Alzheimer's disease patient for whom a therapeutic garden protocol has proposed them
    Patient atteint de la maladie d'Alzheimer pour lesquels un protocole de jardin thérapeutique leur ait proposé
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    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
    To assess the impact of the use of the Therapeutic Garden by people living with Alzheimer's disease on the carbohydrate metabolism in cerebral PET / CT with 18F-FDG.
    Evaluer l’impact de l’utilisation du Jardin thérapeutique par des personnes vivant avec une maladie d’Alzheimer sur le métabolisme glucidique en TEP/TDM cérébrale au 18F-FDG.
    E.2.2Secondary objectives of the trial
    1. Evaluate the impact of the use of the Alzheimer Therapeutic Garden (JAZ program) on carbohydrate metabolism in cerebral PET / CT with 18F-FDG using the actimetry parameter as a covariate in the model.
    2. Evaluate the impact of the use of the Therapeutic Garden on people living with Alzheimer's disease on the self-awareness questionnaire (QCS).
    3. Correlate the metabolism of the brain regions with the clinical variables (neuropsychological assessment, QCS) before and after using the therapeutic garden.
    4. Evaluate the impact of the use of the therapeutic garden on the electrodermal response (RED).
    1. Evaluer l’impact de l’utilisation du Jardin thérapeutique Alzheimer (programme JAZ) sur le métabolisme glucidique en TEP/TDM cérébrale au 18F-FDG en utilisant le paramètre actimétrie comme covariable dans le modèle.
    2. Evaluer l’impact de l’utilisation du Jardin thérapeutique sur les personnes vivant avec une maladie d’Alzheimer sur le questionnaire de conscience de soi (QCS).
    3. Corréler le métabolisme des régions cérébrales avec les variables cliniques (bilan neuropsychologique, QCS) avant et après utilisation du jardin thérapeutique.
    4. Evaluer l’impact de l’utilisation du jardin thérapeutique sur la réponse électrodermale (RED).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patient with AD at the light to moderate stage, followed at the CMRR (MMS 15-23) and having benefited during their diagnostic care from a PET / CT scan at 18F-FDG having a companion for the duration of the study .
    • Patient with a neuropsychological assessment (MOCA, DO80, BREF, HAD) of less than 3 months. (If the last neuropsychological assessment was more than 3 months ago, these tests are performed in routine care during the consultation during which the study will be offered and consent obtained)
    • Symptomatic treatment of AD (anticholinesterase or memantine) if prescribed, at a stable dose for 1 month, stable psychotropic treatment for 1 month
    • Person affiliated with a social security scheme or beneficiary of such a scheme.
    • Patient over 18 years old.
    • Person having received complete information on the organization of the research and having signed their informed consent.
    • Patient atteint de MA au stade léger à modéré, suivi au CMRR (MMS 15-23) et ayant bénéficié lors de leur prise en charge diagnostique d’une TEP/TDM au 18F-FDG ayant un accompagnant pour la durée de l’étude.
    • Patient ayant un bilan neuropsychologique (MOCA, DO80, BREF, HAD) de moins de 3 mois. (Si le dernier bilan neuropsychologique date de plus de 3 mois, ces tests sont effectués en soins courants lors de la consultation au cours de laquelle l’étude sera proposée et le consentement recueilli)
    • Traitement symptomatique de la MA (anticholinestérasique ou mémantine) si prescrit, à dose stable depuis 1 mois, traitement psychotrope stable depuis 1 mois
    • Personne affiliée à un régime de sécurité sociale ou bénéficiaire d’un tel régime.
    • Patient âgé de plus de 18 ans.
    • Personne ayant reçu l’information complète sur l’organisation de la recherche et ayant signé son consentement éclairé.
    E.4Principal exclusion criteria
    • Impairment of understanding interfering with participation in the protocol (score> 2 of the MMS comprehension test at inclusion)
    • Patient who did not have biomarkers identified by lumbar puncture
    • Patient unable to perform a cerebral PET scan with 18F-FDG (maintaining a lying position for more than 20 minutes)
    • Patient unable to follow the therapeutic program of the garden.
    • Woman of childbearing age who does not have effective contraception.
    • Pregnant woman or nursing mother.
    • Person referred to in articles L. 1121-5, L. 1121-7 and L1121-8 of the public health code.
    • Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care under Articles L. 3212-1 and L. 3213-1.
    • Troubles de la compréhension interférant avec la participation au protocole (score >2 de l’épreuve de compréhension du MMS à l’inclusion)
    • Patient n’ayant pas eu de biomarqueurs identifiés par ponction lombaire
    • Patient dans l’impossibilité de réaliser une TEP cérébrale au 18F-FDG (maintien d’une position allongée pendant plus de 20 minutes)
    • Patient dans l’impossibilité de suivre le programme thérapeutique du jardin.
    • Femme en âge de procréer ne disposant pas de moyen de contraception efficace.
    • Femme enceinte ou mère allaitante.
    • Personne visée aux articles L. 1121-5, L. 1121-7 et L1121-8 du code de la santé publique.
    • Les personnes privées de liberté par une décision judiciaire ou administrative, les personnes faisant l'objet de soins psychiatriques en vertu des articles L. 3212-1 et L. 3213-1.
    E.5 End points
    E.5.1Primary end point(s)
    Topography of brain regions, whose carbohydrate metabolism has significantly changed in cerebral PET / CT with 18F-FDG before and after using the Therapeutic Garden
    Topographie des régions cérébrales, dont le métabolisme glucidique s’est significativement modifié en TEP/TDM cérébrale au 18F-FDG avant et après l’utilisation du Jardin thérapeutique
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 months after inlcusion of the patient
    1 mois après l’inclusion du patient
    E.5.2Secondary end point(s)
    1. Topography of the brain regions, whose carbohydrate metabolism has significantly changed in cerebral PET / CT with 18F-FDG before and after the use of the Therapeutic Garden by people living with Alzheimer's disease by integrating the actimetry as
    co-variable in the model.
    2. Comparison of QCS before and after using the therapeutic garden
    3. Topography of brain regions, whose carbohydrate metabolism covariates with clinical variables (neuropsychological assessment, QCS).
    4. Modifications of the RED score during the use of the garden
    1. Topographie des régions cérébrales, dont le métabolisme glucidique s’est significativement modifié en TEP/TDM cérébrale au 18F-FDG avant et après l’utilisation du Jardin thérapeutique par des personnes vivant avec la maladie d’Alzheimer en intégrant l’actimètrie comme
    co-variable dans le modèle.
    2. Comparaison du QCS avant et après utilisation du jardin thérapeutique
    3. Topographie des régions cérébrales, dont le métabolisme glucidique covarie avec les variables cliniques (bilan neuropsychologique, QCS).
    4. Modifications du score de RED durant l’utilisation du jardin
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 months after inclusion of each patient, we will have all information to evaluate this secondary end points
    1 mois après l'inclusion de chaque patient, nous aurons les données nécessaires pour répondre à ces critères d’évaluations secondaires
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind Yes
    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.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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
    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 months
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state25
    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 Decision2021-07-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-30
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu May 02 17:47:31 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA