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    Summary
    EudraCT Number:2022-001751-17
    Sponsor's Protocol Code Number:IIBSP-DON-2022-43
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-01-31
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2022-001751-17
    A.3Full title of the trial
    Multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of donepezil versus placebo in mild cognitive impairment associated with Parkinson's disease
    Ensayo clínico multicéntrico, aleatorizado, doble ciego y controlado por placebo, de evaluación de la eficacia y la seguridad del donepezilo versus placebo en el deterioro cognitivo leve asociado a la Enfermedad de Parkinson
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study evaluating the efficacy and safety of donepezil versus placebo in mild cognitive impairment associated with Parkinson's disease
    Estudio de evaluación de la eficacia y la seguridad del donepezilo versus placebo en el deterioro cognitivo leve asociado a la Enfermedad de Parkinson
    A.4.1Sponsor's protocol code numberIIBSP-DON-2022-43
    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 SponsorInstitut de Recerca Hospital de la Santa Creu i Sant Pau - IIB Sant Pau
    B.1.3.4CountrySpain
    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 supportInstituto de Salud Carlos III
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut de Recerca H. Santa Creu i Sant Pau
    B.5.2Functional name of contact pointUICEC Sant Pau
    B.5.3 Address:
    B.5.3.1Street AddressSant Quinti 77-79
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08041
    B.5.3.4CountrySpain
    B.5.4Telephone number+34935537636
    B.5.5Fax number+34935537856
    B.5.6E-mailuicec@santpau.cat
    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 Aricept
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer S.L.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 typeup to
    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
    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
    Parkinson's disease
    Enfermedad de Parkinson
    E.1.1.1Medical condition in easily understood language
    Parkinson's disease
    Enfermedad de Parkinson
    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
    • Safety: Evaluate the safety of donepezil administered for 12 months by measuring blood pressure (BP), heart rate (HR), blood tests, Movement Disorders Society Unified Parkinson's Disease Rating Scale part III (MDS UPDRS-III), ECG, and recording of adverse effects.
    • Primary efficacy: To assess the effects of donepezil administered for 12 months on global cognitive performance by analyzing changes in the Parkinson's Disease-Cognitive Rating Scale (PD-CRS) from baseline to 12 months.
    • Seguridad: Evaluar la seguridad de donepezilo administrado durante 12 meses mediante la realización de medidas de tensión arterial (TA), frecuencia cardiaca (FC), analítica sanguínea, Movement Disorders Society Unified Parkinson's Disease Rating Scale part III (MDS UPDRS-III), ECG, y registro de efectos adversos.
    • Primario de eficacia: Evaluar los efectos de donepezilo administrado durante 12 meses en el rendimiento cognitivo global analizando cambios en la escala Parkinson's Disease-Cognitive Rating Scale (PD-CRS) desde situación basal a los 12 meses.
    E.2.2Secondary objectives of the trial
    - To assess the effects on cognitive functional performance by analyzing changes in the Parkinson's Disease-Cognitive Functional Rating Scale (PD-CFRS)
    - Evaluate the effects in different tests and cognitive domains analyzing the changes in Trail Making Test A (TMT-A), Direct Digit Span (DSd), Trail Making Test B (TMT-B), Phonetic Fluency (FF), Boston Naming Test (BNTr), Semantic fluency (FS), Free and cued selective reminding test (FCSRT), Rey-Osterrieth complex figure test (ROCF), ROCF recall (rROCF), and Judgment of line orientation (JLO)
    - Evaluate the effects on anxiety, depression, apathy, psychosis, sleep and dysautonomia
    - Assess the effects on quality of life
    - Evaluate the effects on the severity and changes in the general clinical state of the patient,
    - To assess the effects on the subjective cognitive state by analyzing changes in the Patient Global Impression of Change (PGIC) scale.
    - Evaluar los efectos en el rendimiento funcional cognitivo analizando cambios en la escala Parkinson's Disease-Cognitive Functional Rating Scale (PD-CFRS)
    - Evaluar los efectos en diferentes pruebas y dominios cognitivos analizando los cambios en Trail Making Test A (TMT-A), Digit Span directo (DSd), Trail Making Test B (TMT-B), Fluencia Fonética (FF), Boston Naming Test reducida (BNTr), Fluencia semántica (FS), Free and cued selective reminding test (FCSRT), Rey-Osterrieth complex figure test (ROCF), recuerdo de ROCF (rROCF), y Judgment of line orientation (JLO)
    - Evaluar los efectos en ansiedad, depresión, apatía, psicosis, sueño y disautonomía
    - Evaluar los efectos en la calidad de vida
    - Evaluar los efectos en la severidad y los cambios del estado clínico general del paciente ,
    - Evaluar los efectos en el estado cognitivo subjetivo analizando cambios en la escala Patient Global Impression of Change (PGIC)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - 50-80 years (included)
    - Diagnosis of PD based on MDS criteria(45)
    - Neuroimaging compatible with PD
    - Hoehn and Yahr Stadium (H&Y) I-III (included)
    - Persistent subjective cognitive complaints in the 6 months prior to Screening
    - Diagnosis of MCI-EP by MDS MCI-EP criteria:
    - Duration of DCL-EP of at least 3 months prior to Screening
    - Stable dopaminergic treatment in the 4 weeks prior to Screening
    - 50-80 años (incluidos)
    - Diagnóstico de EP en base a criterios MDS(45)
    - Neuroimagen compatible con EP
    - Estadio Hoehn y Yahr (H&Y) I-III (incluidos)
    - Quejas cognitivas subjetivas persistentes en los 6 meses previos al Screening
    - Diagnóstico de DCL-EP por criterios MDS DCL-EP:
    - Duración de DCL-EP de, al menos, 3 meses previo al Screening
    - Tratamiento dopaminérgico estable en las 4 semanas previas al Screening
    E.4Principal exclusion criteria
    - Criteria for dementia associated with PD(49)
    - Severe motor complications (moderate-severe motor fluctuations defined as a score >1 on MDS UPDRS Part IV item 42; or disabling dyskinesias defined as a score >1 on MDS UPDRS Part IV item 36)
    - History of Deep Brain Stimulation
    - Active or antipsychotic psychosis, major hallucinations, HADS score ≥11, active impulse control disorder, or other active severe behavioral disorders
    - Active treatment with anticholinergics, acetylcholinesterase inhibitors or other systemic cholinergic enhancers, or neuroleptics
    - Hypersensitivity or intolerance to donepezil, to piperidine derivatives, to lactose or to any of the excipients of the active drug
    - Criterios de demencia asociada a EP(49)
    - Complicaciones motoras severas (fluctuaciones motoras moderadas-severas definidas como una puntuación >1 del ítem 42 de la parte IV de la MDS UPDRS; o discinesias incapacitantes definidas como una puntuación >1 en el ítem 36 de la parte IV de la MDS UPDRS)
    - Historia de Estimulación Cerebral Profunda
    - Psicosis activa o con tratamiento antipsicótico, alucinaciones mayores, puntuación HADS ≥11, trastorno del control de impulsos activo u otros trastornos conductuales severos activos
    - Tratamiento activo con anticolinérgicos, inhibidores de la acetilcolinesterasa u otros potenciadores colinérgicos sistémicos, o neurolépticos
    - Hipersensibilidad o intolerancia a donepezilo, a derivados de piperidina, a la lactosa o a alguno de los excipientes del fármaco activo
    E.5 End points
    E.5.1Primary end point(s)
    Parkinson's Disease-Cognitive Rating Scale (PD-CRS):
    Parkinson's Disease-Cognitive Rating Scale (PD-CRS):
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 meses
    E.5.2Secondary end point(s)
    Trail Making Test A (TMT-A)
    Direct Digit Span (DSd)
    Trail Making Test B (TMT-B)
    Boston Nomination Test reduced (BNTr)
    phonetic fluency
    semantic fluency
    Free and Cued Selective Reminding Test (FCSRT)
    Hospital Anxiety and Depression Scale (HADS)
    Starkstein Apathy Scale (AS)
    Neuropsychiatric Inventory (NPI):
    MDS UPDRS-I and -II
    Schwab & England Scale (S&E)
    8-item Parkinson's Disease Questionnaire (PDQ-8):
    Clinical Global Impressions (CGI-S and CGI-I)
    Patients Global Impression of Change (PGIC)
    Montreal Cognitive Assessment (MoCA)
    Trail Making Test A (TMT-A)
    Digit Span directo (DSd)
    Trail Making Test B (TMT-B)
    Boston Nomination Test reducida (BNTr)
    Fluencia fonética
    Fluencia semántica
    Free and Cued Selective Reminding Test (FCSRT)
    Hospital Anxiety and Depression Scale (HADS)
    Starkstein Apathy Scale (AS)
    Neuropsychiatric Inventory (NPI):
    MDS UPDRS-I y -II
    Escala de Schwab & England (S&E)
    8-item Parkinson’s Disease Questionnaire (PDQ-8):
    Clinical Global Impressions (CGI-S y CGI-I)
    Patients Global Impression of Change (PGIC)
    Montreal Cognitive Assessment (MoCA)
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months
    12 meses
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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) 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 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 concerned20
    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
    UVUS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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: 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)
    Expected normal treatment of the condition
    Tratamiento habitual
    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 Decision2023-07-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-05-03
    P. End of Trial
    P.End of Trial StatusOngoing
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