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    Summary
    EudraCT Number:2020-000576-38
    Sponsor's Protocol Code Number:CARL
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-02-11
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-000576-38
    A.3Full title of the trial
    Effect of treatment of the cholinergic precursor Choline Alfoscerate in mild cognitive dysfunction
    Effetto del trattamento del precursore Colinergico Colina Alfoscerato nella disfunzione cognitiva lieve
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    n.a.
    n.a.
    A.3.2Name or abbreviated title of the trial where available
    n.a.
    n.a.
    A.4.1Sponsor's protocol code numberCARL
    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 SponsorUNIVERSITA' DEGLI STUDI DI CAMERINO
    B.1.3.4CountryItaly
    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 supportITALFARMACO S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversità degli Studi di Camerino
    B.5.2Functional name of contact pointCentro di Ricerche Cliniche, Teleme
    B.5.3 Address:
    B.5.3.1Street AddressVia Madonna delle Carceri, 9 (MC)
    B.5.3.2Town/ cityCamerino (MC)
    B.5.3.3Post code62032
    B.5.3.4CountryItaly
    B.5.4Telephone number0737401725
    B.5.6E-mailenea.traini@unicam.it
    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.2.1.1.1Trade name GLIATILIN - 10 FLAC.ORALI 600 MG
    D.2.1.1.2Name of the Marketing Authorisation holderITALFARMACO S.P.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameGLIATILIN 600 mg flaconcini
    D.3.2Product code [n.d.]
    D.3.4Pharmaceutical form Oral solution
    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 INNCOLINA ALFOSCERATO
    D.3.9.1CAS number 28319-77-9
    D.3.9.2Current sponsor coden.d.
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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 Yes
    D.3.11.13.1Other medicinal product typeprecursore parasimpatico dell'acetilcolina
    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 placeboOral solution
    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
    Mild cognitive dysfunction
    Disfunzione cognitiva lieve
    E.1.1.1Medical condition in easily understood language
    Mild cognitive dysfunction
    Disfunzione cognitiva lieve
    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 SOC
    E.1.2Classification code 10037175
    E.1.2Term Psychiatric disorders
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The study intends to evaluate the slowing and / or stability of hippocampal atrophy, entorhinal cortex, neocortex and ventricular dilation through the use of a cholinergic precursor (choline alfoscerate) in patients with mild cognitive dysfunction with associated vascular damage.
    Lo studio intende valutare il rallentamento e/o la stabilità dell'atrofia dell'ippocampo, della corteccia entorinale, della neocorteccia e della dilatazione ventricolare mediante l'utilizzo di un precursore colinergico (colina alfoscerato) in pazienti con lieve disfunzione cognitiva con associato danno vascolare.
    E.2.2Secondary objectives of the trial
    The study intends to evaluate whether the effectiveness of the cholinergic precursor Choline Alfoscerate is superior to that of placebo in the stability and / or improvement of cognitive abilities.
    Functional performances and changes in mood and motivation will also be monitored.
    Safety and tolerability of the study drug will be.
    Lo studio intende valutare se l'efficacia del precursore colinergico Colina Alfoscerate è superiore a quella del placebo nella stabilità e/o miglioramento delle capacità cognitive.
    Verranno inoltre monitorate le performance funzionali e i cambiamenti di umore e motivazione.
    La sicurezza e la tollerabilità del farmaco in studio saranno.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient able to understand and sign informed consent and informed consent signed by family member/caregiver
    2. Age = 65 years
    3. Memory disorders presence evaluated by Neuropsychological Testing (see below):
    • Mini Mental State Evaluation (MMSE, Folstein et al 1975): score= 24
    • Clinical Dementia Rating (CDR) = 0,5
    4. Sufficient education to enable the patient to read, write and communicate effectively
    5. Indipendent patient in daily, family, work and / or social activities
    6. Cooperative patient and able to complete all aspects of the study alone or with the help of a family member
    7. Patient living with or in contact with a family member / caregiver who cooperates in the efficacy evaluation
    8. MRI performed within 6 (six) months prior to enrollment
    9. Presence of at least 2 (two) vascular risk factors listed below:
    ¿ systemic arterial hypertension
    ¿ diabetes mellitus
    ¿ obesity
    ¿ heart disease (e.g. atrial fibrillation)
    ¿ dyslipidaemia
    ¿ hyperhomocysteinemia
    ¿ tobacco addiction
    ¿ previous cerebrovascular events
    ¿ family history of cardio-cerebrovascular diseases
    1. Paziente in grado di comprendere e firmare il consenso informato e il consenso informato firmato dal familiare/caregiver
    2. Età = 65 anni
    3. Presenza di disturbi della memoria valutata dai Test Neuropsicologici (vedi sotto):
    • Mini Mental State Evaluation (MMSE, Folstein et al 1975): punteggio = 24
    • Valutazione della demenza clinica (CDR) = 0,5
    4. Un'istruzione sufficiente per consentire al paziente di leggere, scrivere e comunicare in modo efficace
    5. Paziente autonomo nelle attività quotidiane, familiari, lavorative e/o sociali
    6. Paziente collaborativo e in grado di completare tutti gli aspetti dello studio da solo o con l'aiuto di un familiare
    7. Paziente che vive con o è in contatto con un familiare/caregiver che collabora alla valutazione dell'efficacia
    8. Risonanza magnetica eseguita entro 6 (sei) mesi prima dell'arruolamento
    9. Presenza di almeno 2 (due) fattori di rischio vascolare sotto elencati:
    ¿ ipertensione arteriosa sistemica
    ¿ diabete mellito
    ¿ obesità
    ¿ malattie cardiache (es. fibrillazione atriale)
    ¿ dislipidemia
    ¿ iperomocisteinemia
    ¿ dipendenza da tabacco
    ¿ precedenti eventi cerebrovascolari
    ¿ storia familiare di malattie cardio-cerebrovascolari
    E.4Principal exclusion criteria
    1. Overt Alzheimer’s disease
    2. All decompensated cardiac disorders
    3. Chronic renal failure
    4. Severe hepatic insufficiency
    5. Incorrect dysthyroidism (Level T3 different from 1,1 - 2,6 nmol/L, T4 different from 60 - 150 nmol/L)
    6. Serious ongoing developmental systemic pathologies (eg. malignancies)
    7. Any advanced, progressive or unstable disease that, in the opinion of the investigator, could interfere with efficacy or safety assessments or that could put the patient at risk by participation in the study
    8. Psychiatric disorders or mental retardation (Severe Depression, Psychosis, Dissociative Syndrome)
    9. Alcohol / drug / substance abuse or dependence
    10. Diagnosis of Major Depression according to (DSM V), except in cases successfully treated with stable dose of antidepressant (non-anticholinergic) for at least 4 weeks prior to recruitment
    11. FrofAny contraindication to treatment or intolerance to choline alfoscerate
    12. Patient involved in other clinical trials
    1. Malattia di Alzheimer conclamata
    2. Tutti i disturbi cardiaci scompensati
    3. Insufficienza renale cronica
    4. Insufficienza epatica grave
    5. Distiroidismo non corretto (Livello T3 diverso da 1,1 - 2,6 nmol/L, T4 diverso da 60 - 150 nmol/L)
    6. Patologie sistemiche evolutive gravi in corso (es. tumori maligni)
    7. Qualsiasi malattia avanzata, progressiva o instabile che, a parere dello sperimentatore, potrebbe interferire con le valutazioni di efficacia o sicurezza o che potrebbe mettere a rischio il paziente a causa della partecipazione allo studio
    8. Disturbi psichiatrici o ritardo mentale (depressione grave, psicosi, sindrome dissociativa)
    9. Abuso o dipendenza da alcol/droghe/sostanze
    10. Diagnosi di Depressione Maggiore secondo (DSM V), tranne nei casi trattati con successo con dose stabile di antidepressivo (non anticolinergico) per almeno 4 settimane prima del reclutamento
    11. Per qualsiasi controindicazione al trattamento o intolleranza alla colina alfoscerato
    12. Pazienti coinvolti in altri studi clinici
    E.5 End points
    E.5.1Primary end point(s)
    The slowing and / or stability of hippocampal atrophy, entorhinal cortex, neocortex and ventricular dilation through the use of a cholinergic precursor (choline alfoscerate) in patients with mild cognitive dysfunction with associated vascular damage will be measured using the MMSE scale at the final visit compared to baseline.
    Il rallentamento e/o la stabilità dell'atrofia dell'ippocampo, della corteccia entorinale, della neocorteccia e della dilatazione ventricolare attraverso l'uso di un precursore colinergico (colina alfoscerato) in pazienti con lieve disfunzione cognitiva con associato danno vascolare sarà misurato utilizzando la scala MMSE alla visita finale rispetto alla baseline.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The final visit compared to baseline.
    Visita finale rispetto alla baseline.
    E.5.2Secondary end point(s)
    The stability and/or improvement of cognitive abilities will be assessed through the use of neuropsychological scales that will evaluate the cognitive performance of patients (executive, memory, visual-constructive, linguistic and attentional functions) at the end of the study compared to the baseline visit.
    Functional performances and changes in mood and motivation will be evaluated with specific neuropsychological tests.
    La stabilità e/o il miglioramento delle capacità cognitive sarà valutata attraverso l'utilizzo di scale neuropsicologiche che valuteranno le prestazioni cognitive dei pazienti (funzioni esecutive, mnemoniche, visuo-costruttive, linguistiche e attenzionali) al termine dello studio rispetto alla baseline.
    Le prestazioni funzionali ei cambiamenti di umore e motivazione saranno valutati con specifici test neuropsicologici.
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of the study compared to the baseline.
    Termne dello studio rispetto alla baseline.
    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 Yes
    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 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 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.8.2.4Number of treatment arms in the trial2
    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 Information not present in EudraCT
    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
    LVLS
    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 days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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) No
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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)
    n.a.
    n.a.
    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 Decision2022-05-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-08
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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