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    EudraCT Number:2019-004634-41
    Sponsor's Protocol Code Number:IIBSP-FPI-2019-108
    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:2020-06-04
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2019-004634-41
    A.3Full title of the trial
    Study of the positron emission tomography (PET) tracer for tau 18F-PI-2620 in individuals with Down syndrome
    Estudio del trazador de tomografía por emisión de positrones (PET) para tau 18F-PI-2620 en individuos com síndrome de Down
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the positron emission tomography (PET) tracer for tau 18F-PI-2620 in individuals with Down syndrome
    Estudio del trazador de tomografía por emisión de positrones (PET) para tau 18F-PI-2620 en individuos com síndrome de Down
    A.4.1Sponsor's protocol code numberIIBSP-FPI-2019-108
    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 HSCSP
    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 supportInstitut de Recerca HSCSP
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut de Recerca HSCSP
    B.5.2Functional name of contact pointUICEC Sant Pau
    B.5.3 Address:
    B.5.3.1Street AddressSant Quintí, 77 - 79
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08041
    B.5.4Telephone number34935537634
    B.5.5Fax number34935537864
    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 No
    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 name18F-PI-2620
    D.3.2Product code 18F-PI-2620
    D.3.4Pharmaceutical form Radiopharmaceutical precursor
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN18F-PI-2620
    D.3.9.2Current sponsor code18F-PI-2620
    D.3.9.3Other descriptive name(2-(2-([18F]fluoro)pyridin-4-yl)-9H-pyrrolo[2,3-b:4,5-c']dipyridine)
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number185
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    E.1.1.1Medical condition in easily understood language
    Neurodegenerative conditions characterized by the cerebral accumulation of the protein tau
    Enfermedades neurodegenerativas caracterizadas por la acumulación cerebral de proteína tau
    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 obtain preliminary information on the efficacy of 18F-PI-2620 in the detection of tau pathology in AD associated with SD
    - To evaluate the safety of 18F-PI-2620 in healthy subjects, subjects with SD.
    - Obtener información preliminar sobre la eficacia de 18F-PI-2620 en la detección de patología tau en la EA asociada al SD
    - Evaluar la seguridad de 18F-PI-2620 en sujetos sanos, sujetos con SD.
    E.2.2Secondary objectives of the trial
    To correlate the uptake of 18F-PI-2620 with:
    - Cognitive and functional scales.
    - Measures of cerebral atrophy in MRI.
    - Tau and phosphorylated tau levels in the cerebrospinal fluid.
    Correlacionar la captación de 18F-PI-2620 con:
    - Las escalas cognitivas y funcionales.
    - Medidas de atrofia cerebral en la RM.
    - Los niveles de tau y tau fosforilada en el líquido cefalorraquídeo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Criteria of control subjects:
    - Men and women with age> 35 years.
    - Absence of cognitive complaints.
    - Normal neuropsychological examination with MMSE scores between 24 and 30, absence of subjective memory complaints or objective memory deficit (measured with the Free and Cued Selective Reminding Test - FCSRT- (Grober, Buschke et al. 1988)) with a scalar score equal to or greater than 8 and a clinical dementia rating scale (CDR) score of 0 (Morris 1993).
    - Understand and accept the study procedures and sign an informed consent (guardian and / or patient).

    Inclusion criteria for participants with DS:
    - Men and women diagnosed with DS> 35 years.
    - Intellectual quotient> 34 (equivalent to mild and moderate mental retardation according to ICD-10 criteria).
    - Existence of reliable informant.
    - Participants / legal guardians who sign the IC for inclusion in the study.
    Criterios de sujetos controles:
    - Hombres y mujeres con edad > 35 años.
    - Ausencia de quejas cognitivas.
    - Normalidad de la exploración neuropsicológica con puntuaciones en el MMSE entre 24 y 30, ausencia de quejas subjetivas de memoria o déficit objetivo de memoria (medido con el Free and Cued Selective Reminding Test - FCSRT- (Grober, Buschke et al. 1988)) con una puntuación escalar igual o mayor a 8 y una puntuación en el clinical dementia rating scale (CDR) de 0 (Morris 1993).
    - Comprender y aceptar los procedimientos del estudio y firmar un consentimiento informado (tutor y/o paciente).

    Criterios de inclusión para participantes con SD:
    - Hombres y mujeres diagnosticados de SD > de 35 años.
    - Cociente intelectual > 34 (equivalente a retraso mental leve y moderado según criterios del CIE-10).
    - Existencia de informador fiable.
    - Participantes/ tutores legales que firmen el CI para inclusión en el estudio.
    E.4Principal exclusion criteria
    - Not meeting the inclusion criteria.
    - Severe depression (Geriatric scale score Scale depression> 20).
    - History of stroke, Hachinski score> 4 or previous neurological or psychiatric illness.
    - Confirmed pregnancy or possibility of pregnancy at the time of inclusion in the study.
    - No cumplir los criterios de inclusión.
    - Depresión grave (puntuación escala Geriatric Depresión Scale>20).
    - Historia de ictus, puntuación de Hachinski >4 o enfermedad neurológica o psiquiátrica previas.
    - Embarazo confirmado o posibilidad de embarazo en el momento de la inclusión en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    - Standardized uptake value ratio (SUVR) of images generated with 18F-PI-2620 (images measured between 0-90 min of administration will be obtained; SUVR images of 18F-PI-2620 will be corrected to the RM using the software SPM8. The cerebellum will be used as the reference region), as a measure of tau protein aggregates in the brain.

    - Presence of adverse effects within 24 hours after administration.
    - Standardized uptake value ratios (SUVR) de las imágenes generadas con 18F-PI-2620 (se obtendrán imágenes medidas entre 0-90 min de la administración; las imágenes SUVR del 18F-PI-2620 serán corregistradas a la RM usando el software SPM8. Se usará el cerebelo como región de referencia), como medida de agregados de proteína tau en el cerebro.

    - Presencia de efectos adversos durante las 24 horas posteriores a la administración.
    E.5.1.1Timepoint(s) of evaluation of this end point
    90 minutes
    90 minutos
    E.5.2Secondary end point(s)
    - Correlation of SUVR with the clinical variables (CAMDEX-DS, CAMCOG) that will be obtained from the patient's medical history.
    - Correlation with measures of cerebral atrophy measured by FreeSurfer in MR (cortical thickness).
    - Correlation with the measures of tau and phosphorylated tau in CSF.
    - Correlación de SUVR con las variables clínicas (CAMDEX-DS, CAMCOG) que se obtendrán de la historia clínica del paciente.
    - Correlación con las medidas de atrofia cerebral medidas mediante FreeSurfer en RM (grosor cortical).
    - Correlación con las medidas de tau y tau fosforilada en LCR.
    E.5.2.1Timepoint(s) of evaluation of this end point
    90 minutes
    90 minutos
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 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. 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 No
    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.8.2.4Number 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.8.5The 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 months24
    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: 80
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state80
    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
    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 Decision2021-08-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-22
    P. End of Trial
    P.End of Trial StatusOngoing
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