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    Summary
    EudraCT Number:2022-002987-57
    Sponsor's Protocol Code Number:AL002-LTE
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-12-21
    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 number2022-002987-57
    A.3Full title of the trial
    A Multicenter, Long-Term Extension Study to Evaluate the Safety, Tolerability, and Efficacy of AL002 in Participants with Alzheimer’s Disease
    Studio di estensione a lungo termine, multicentrico volto a valutare la sicurezza, la tollerabilità e l'efficacia di AL002 nei partecipanti con morbo di Alzheimer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Trial to evaluate AL002 in Participants with early Alzheimer's Disease
    Sperimentazione clinica volta a valutare AL002 in partecipanti con malattia di Alzheimer in fase iniziale
    A.3.2Name or abbreviated title of the trial where available
    AL002-LTE
    AL002-LTE
    A.4.1Sponsor's protocol code numberAL002-LTE
    A.5.4Other Identifiers
    Name:INDNumber:136758
    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 SponsorAlector Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAlector, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlector Inc.
    B.5.2Functional name of contact pointMedical Doctor
    B.5.3 Address:
    B.5.3.1Street Address131 Oyster Point Blvd, Suite 600
    B.5.3.2Town/ citySouth San Francisco
    B.5.3.3Post codeCA 94080
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials@alector.com
    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 nameAL002
    D.3.2Product code [AL002]
    D.3.4Pharmaceutical form Solution for infusion
    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.3.9.2Current sponsor codeAL002
    D.3.9.3Other descriptive nameHuman IgG1 monoclonal antibody against TREM2
    D.3.9.4EV Substance CodeSUB198089
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    Early Alzheimer's Disease
    Malattia di Alzheimer in fase iniziale
    E.1.1.1Medical condition in easily understood language
    Alzheimer's Disease
    Malattia di 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 SOC
    E.1.2Classification code 10029205
    E.1.2Term Nervous system disorders
    E.1.2System Organ Class 10029205 - Nervous system disorders
    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 long-term safety and tolerability of IMP (AL002) in participants with AD.

    To evaluate the effect of immunogenicity to IMP on safety, PK, and PD biomarkers in participants with AD.
    Valutare la sicurezza e la tollerabilità a lungo termine del prodotto medicinale sperimentale (IMP)
    (AL002) in partecipanti con AD.

    Valutare l'effetto dell'immunogenicità verso l'IMP su sicurezza, farmacocinetica (PK) e biomarcatori di
    farmacodinamica (PD) in partecipanti con AD.
    E.2.2Secondary objectives of the trial
    To evaluate the effects of IMP in participants with AD on exploratory clinical outcome assessments (COAs) and PD biomarkers.
    Valutare gli effetti dell'IMP in partecipanti con AD sulle valutazioni esplorative degli esiti clinici (COA) e sui
    biomarcatori PD
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The participant has completed the Planned Treatment Period in the AL002-2 study. Completion of the Planned Treatment Period is defined as any participant who did not prematurely and permanently discontinue IMP in the AL002-2 study.
    2. The participant is willing and able to give informed consent. Where local regulations permit inclusion of participants deemed not able to provide informed consent, a legally authorized representative must provide informed consent on his or her behalf, and the participant must provide assent, in accordance with the local regulations, guidelines, and institutional review board or independent ethics committee.
    3. The participant has availability of a person (“study partner”) who, in the Investigator’s opinion, has frequent and sufficient contact with the participant (eg, at least 10 hours per week of in person contact), is able to provide accurate information regarding the participant’s cognitive and functional abilities, agrees to provide information at clinic visits (which require partner input for scale completion), and signs the necessary consent form.
    a. The study partner must have sufficient cognitive capacity, in the Investigator’s opinion, to accurately report upon the participant’s behavior, cognitive, and functional abilities. The study partner should be in sufficiently good general health, in the Investigator’s opinion, to have a high likelihood of maintaining the same level of interaction with the participant and participation in study procedures throughout the study duration.
    b. Every effort should be made to have the same study partner participate throughout the duration of the study, and to have the same study partner as in the parent study.
    4. The participant and study partner are fluent in the language of the tests used at the study site as assessed by site personnel.
    5. The participant is willing and able to complete all aspects of the study (including MRI, optional LP, genotyping, and optional PET imaging, as applicable). The participant should be capable of completing assessments either alone or with the help of the study partner.
    6. The participant has adequate visual and auditory acuity, in the Investigator’s opinion, sufficient to perform the neuropsychological testing (corrective lenses and hearing aids are permitted).
    7. Participant agrees not to donate blood or blood products for transfusion for the duration of the study and for 1 year after the final dose of study drug.
    Inclusion criteria for participants in the optional tau PET imaging assessment with [18F]MK-6240 only:
    8. Participant has not had excessive radiation exposure prior to enrollment in the trial, as defined by local standards.
    9. [18F]MK-6240 is available to the PET imaging center based on manufacturing distribution network and local regulations.
    Inclusion criteria for participants in the optional longitudinal amyloid PET imaging assessment only:
    10. Participant has not had excessive radiation exposure prior to enrollment in the trial, as defined by local standards.
    11. An approved amyloid radiotracer is available to the PET imaging center based on manufacturing distribution network and local regulations.
    Inclusion criteria for participants in the optional at-home and/or in-clinic WLSA only:
    12. For at-home participation:
    a. Participant has an available and willing study partner to administer the WLSA.
    b. Participant has WiFi access in their residence or WiFi access in a private area where the testing can take place.
    c. Participant has access to an iPad or iPhone.
    13. For at-home and in-clinic participation, participant must have the linguistic proficiency to complete the proposed assessments and other clinical rating scale
    1. Il partecipante ha completato il periodo di trattamento pianificato nello studio AL002-2. Il completamento del periodo di trattamento pianificato è definito come qualsiasi partecipante che non ha interrotto anticipatamente e definitivamente il trattamento con l'IMP nello studio AL002-2.
    2. Il partecipante è disposto e in grado di fornire il consenso informato. Laddove le normative locali consentano l'arruolamento di partecipanti ritenuti non in grado di fornire il consenso informato, un rappresentante legalmente autorizzato deve fornire il consenso informato per conto del partecipante e questi deve fornire l'assenso, in conformità con le normative locali, le linee guida e il comitato di revisione istituzionale o il comitato etico indipendente.
    3. Il partecipante ha a disposizione una persona ("partner di studio") che, a giudizio dello sperimentatore, ha contatti frequenti e sufficienti con il partecipante (ad es. almeno 10 ore settimanali di contatto di persona), è in grado di fornire informazioni accurate sulle capacità cognitive e funzionali del partecipante, accetta di fornire informazioni alle visite cliniche (che richiedono il contributo del partner per il completamento delle scala di valutazione) e firma il modulo di consenso necessario.
    a. Il partner di studio deve avere una capacità cognitiva sufficiente, secondo l'opinione dello sperimentatore, per riferire accuratamente il comportamento, le capacità cognitive e funzionali del partecipante. Il partner di studio dovrebbe essere in condizioni di salute generale sufficientemente buone, secondo il giudizio dello sperimentatore, da avere un'alta probabilità di mantenere lo stesso livello di interazione con il partecipante e di partecipazione alle procedure dello studio per tutta la durata dello studio.
    b. Dovrebbe essere fatto ogni sforzo per far partecipare lo stesso partner di studio per tutta la durata dello studio e per avere lo stesso partner di studio dello studio principale.
    4. Il partecipante e il partner di studio parlano correntemente la lingua dei test utilizzati nel centro dello studio, come valutato dal personale del centro.
    5. Il partecipante è disposto e in grado di completare tutti gli aspetti dello studio (tra cui RM, LP facoltativa, genotipizzazione e PET facoltativa, a seconda dei casi). Il partecipante dovrebbe essere in grado di completare le valutazioni da solo o con l'aiuto del partner di studio.
    6. Il partecipante ha un'adeguata acuità visiva e uditiva, secondo il giudizio dello sperimentatore, sufficiente per eseguire i test neuropsicologici (sono consentite lenti correttive e apparecchi acustici).
    7. Il partecipante si impegna a non donare sangue o emoderivati per trasfusione per la durata dello studio e per 1 anno dopo la dose finale del farmaco in studio.
    Criteri di inclusione solo per i partecipanti alla valutazione facoltativa della PET tau con [18F]MK-
    6240:
    8. Il partecipante non ha avuto un'eccessiva esposizione alle radiazioni prima dell'arruolamento nello studio, come definito dagli standard locali.
    9. [Il 18F]MK-6240 è disponibile per il centro che esegue la PET in base alla rete di distribuzione della produzione e alle normative locali.
    Criteri di inclusione solo per i partecipanti alla valutazione facoltativa della PET amiloide longitudinale:
    10. Il partecipante non ha avuto un'eccessiva esposizione alle radiazioni prima dell'arruolamento nello studio, come definito dagli standard locali.
    11. Un radiotracciante amiloide approvato è disponibile per il centro che esegue la PET in base alla
    rete di distribuzione della produzione e alle normative locali.
    Criteri di inclusione solo per i partecipanti alla valutazione WLSA facoltativa a domicilio e/o presso il
    centro:
    12. Per la partecipazione a domicilio:
    a. Il partecipante ha un partner di studio disponibile e disposto a somministrare la WLSA.
    b. Il partecipante ha accesso WiFi nella propria residenza o in un'area privata dove possono svolgersi i test.
    c. Il partecipante ha accesso a un iPad o iPhone.
    13. Per la partecipazione a domicilio e presso il centro, il partecipante deve avere la competenza linguistica per completare le valutazioni proposte e altre scale di valutazione clinica.
    E.4Principal exclusion criteria
    1. Participants deemed not able to provide consent or assent by the Investigator or by local regulations.
    2. Participants who were prematurely and permanently discontinued from treatment in the parent
    study for safety reasons. 3. The participant has MRI evidence of:
    a. >2 lacunar infarcts.
    b. Any territorial infarct >1 cm3.
    c. White matter hyperintense lesions on the FLAIR sequence that correspond to an overall Fazekas score of 3.
    d. Participants who have an increase in their number of microbleeds, since the previous screening/ baseline MRI in the AL002-2 study and >5, should be discussed with the Medical Monitor.
    e. Participants who have developed ARIA-E and ARIA-H in the parent study and who were permitted to continue dosing according to the ARIA management guidelines, will not be excluded from participation in the AL002-LTE, on the basis of microbleeds or hemosiderosis.
    4. Participation in the AL002-LTE is deemed inappropriate for any reason per Investigator discretion.
    1. Partecipanti ritenuti non in grado di fornire il consenso o l'assenso secondo il giudizio dello
    sperimentatore o in base alle normative locali.
    2. Partecipanti ai quali sia stato interrotto anticipatamente il trattamento nello studio principale
    per motivi di sicurezza.
    3. Il partecipante presenta evidenza alla RM di:
    a. >2 infarti lacunari.
    b. Qualsiasi infarto territoriale >1 cm3.
    c. Lesioni iperintense della sostanza bianca alla sequenza FLAIR che corrispondono a un punteggio complessivo di Fazekas di 3.
    d. I partecipanti che hanno un aumento del numero di microsanguinamenti, dalla precedente RM di screening/basale nello studio AL002-2 e >5, dovrebbero essere valutati con il responsabile del monitoraggio medico.
    e. I partecipanti che hanno manifestato ARIA-E e ARIA-H nello studio principale e che sono stati autorizzati a continuare il trattamento secondo le linee guida di gestione delle ARIA, non saranno esclusi dalla partecipazione allo studio AL002-LTE, sulla base di microsanguinamenti o emosiderosi.
    4. La partecipazione allo studio AL002-LTE è ritenuta inappropriata per qualsiasi motivo secondo il giudizio dello sperimentatore.
    E.5 End points
    E.5.1Primary end point(s)
    • Incidences of AEs, including AESIs and SAEs
    • Vital signs, clinical laboratory results, and incidence of findings from physical, neurological, ophthalmological exams, and ECG
    • C-SSRS
    • MRI abnormalities
    • Assess the effect of dose titration on ARIA
    • Frequenza di eventi avversi (AE), inclusi eventi avversi di particolare interesse (AESI) ed eventi avversi seri (SAE)
    • Segni vitali, risultati clinici di laboratorio e incidenza dei riscontri di esami obiettivo, neurologico, oftalmologico, ed dell'ECG
    • C-SSRS
    • Anomalie alla risonanza magnetica (RM)
    • Valutare l'effetto della titolazione della dose sulle anomalie ARIA
    E.5.1.1Timepoint(s) of evaluation of this end point
    Incidences of AEs, including AESIs and SAEs during the study, from the time a participant signs ICF until EOS.
    • Vital signs every visit, clinical Lab results at screening week 1,13 29, 41, and EOA/ET, and incidence of findings from physical observed or reported during the study , neurological and ophthalmological exams at screening Week9, 17, 25,33,41,49 and EOS/ST & ECG at screening, week 1,5,9,13,25,49, and EOS/ET
    • C-SSRS_ every visit
    • MRI abnormalities_ Screening, week 9, 17,25,33,41, and EOS/ET
    • Assess the effect of dose titration on ARIA_ For all post-screening MRIs, the MRI should occur at least 5 days prior to the next dose administration and no more than 10 days prior to the next dose administration, with results received from the central imaging vendor prior to dosing
    Incidenza di AEs, comprese AESIs e SAEs durante lo studio, dal momento in cui un partecipante firma ICF fino EOS.
    • Segni vitali ad ogni visita, risultati clinici di laboratorio alla settimana di screening 1,13 29, 41 e EOA/ET, e incidenza dei risultati di esami fisici osservati o riportati durante lo studio , esami neurologici e oftalmologici allo screening Week 9, 17, 25,33,41,49 ed EOS/ST & ECG allo screening, settimana 1,5,9,13,25,49 e EOS/ET
    • C-SSRS_ ogni visita
    • Anormalità MRI, Screening, settimana 9, 17,25,33,41 e EOS/ET
    • Valutare l'effetto della titolazione della dose sull'aria Per tutte le MRI post-screening, la MRI dovrebbe avvenire almeno 5 giorni prima della somministrazione della dose successiva e non più di 10 giorni prima della .........................................
    E.5.2Secondary end point(s)
    •CDR-SB
    • MMSE
    • RBANS-Update
    • ADAS-Cog13
    • ADCS-ADL-MCI
    • ADCOMS
    • Levels of sTREM2 in CSF and/or plasma
    • Levels of biomarkers related to microglia function in CSF and/or plasma (eg, CSF1R, IL1RN, osteopontin, YKL-40)
    • Levels of biomarkers related to AD pathology in CSF and/or plasma (eg, Aß40, Aß42, pTau, tTau)
    • Levels of neurodegeneration biomarkers in plasma and/or CSF (eg, NfL)
    • Brain volume, assessed by volumetric MRI
    • Brain pathological tau burden as assessed by longitudinal tau PET for participants who agree to participate in the optional assessment only •Brain amyloid burden as assessed by longitudinal amyloid PET scanning for participants who agree to participate in the optional assessment only Speech measurements via the WLSA for participants who agree to participate in this optional assessment only
    • CDR¿ -SB
    • MMSE
    • RBANS-Update
    • ADAS-Cog13
    • ADCS-ADL-MCI
    • ADCOMS
    • Livelli di sTREM2 nel liquido cerebrospinale (LCS) e/o nel plasma
    • Livelli di biomarcatori correlati alla funzione della microglia nel LCS e/o nel plasma (ad es. CSF1R, IL1RN, osteopontina, YKL-40)
    • Livelli di biomarcatori correlati alla patologia AD nel LCS e/o nel plasma (ad es. Aß40, Aß42, pTau, tTau)
    • Livelli di biomarcatori di neurodegenerazione nel plasma e/o nel LCS (ad es. NfL)
    • Volume cerebrale, valutato mediante risonanza magnetica (RM) volumetrica
    • Accumulo patologico della proteina tau a livello cerebrale valutato mediante PET tau longitudinale in soggetti che accettano di partecipare solo alla valutazione facoltativa
    • Accumulo di amiloide a livello cerebrale valutato mediante PET amiloide longitudinale in partecipanti che accettano di partecipare solo alla valutazione facoltativa
    • Valutazioni del parlato mediante la WLSA per i soggetti che accettano di partecipare solo a questa valutazione facoltativa
    E.5.2.1Timepoint(s) of evaluation of this end point
    CDR-SB, MMSE, RBANS-Update,ADAS-Cog13, ADCS-ADL-MCI , ADCOMS at screening, week 25, & EOT/ES
    Levels of sTREM2 in CSF and/or plasma, Levels of biomarkers related to microglia function in CSF and/or plasma, Levels of biomarkers related to AD pathology in CSF and/or plasma ,Levels of neurodegeneration biomarkers in plasma and/or CSF ,at the point described on the protocol and scheduled of events
    • Brain volume, assessed by volumetric MRI
    • Brain pathological tau burden as assessed by longitudinal tau PET for participants who agree to participate in the optional assessment only at screening & EOS/ET
    •Brain amyloid burden as assessed by longitudinal amyloid PET scanning for participants who agree to participate in the optional assessment only Speech measurements at screening & EOS/ET
    CDR-SB, MMSE, RBANS-aggiornamento, ADAS-Cog13, ADCS-ADL-MCI , ADCOMS allo screening, settimana 25, & EOT/ES
    Livelli di sTREM2 nel CSF e/o nel plasma, Livelli di biomarcatori correlati alla funzione microglia nel CSF e/o nel plasma, Livelli di biomarcatori correlati alla patologia AD nel CSF e/o nel plasma, Livelli di biomarcatori di neurodegenerazione nel plasma e/o nel CSF,al punto descritto sul protocollo e programmato di eventi
    • Volume del cervello, valutato mediante RM volumetrica
    • Carico tau patologico cerebrale valutato da PET tau longitudinale per i partecipanti che accettano di partecipare alla valutazione opzionale solo allo screening e EOS/ ET
    • Carico di amiloide cerebrale valutato mediante scansione PET dell'amiloide longitudinale per i partecipanti che accettano ...........
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tollerabilità
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 Yes
    E.8.1.7.1Other trial design description
    dose cieca
    dose blind
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA55
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Canada
    United States
    France
    Poland
    Netherlands
    Spain
    Germany
    Italy
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    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
    The end of the study is defined as the date on which the last participant completes the last visit (including the EOS/ET visit).
    La fine dello studio è definita come la data in cui l'ultimo partecipante completa l'ultima visita (compresa la visita di fine studio (End of Study, [EOS])/interruzione anticipata (Early Termination [ET]).
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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) Yes
    F.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Alzheimer's Disease Patients
    pazienti con malattia di Alzheimer
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 133
    F.4.2.2In the whole clinical trial 190
    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
    Nessuno
    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 Decision2023-03-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-01-10
    P. End of Trial
    P.End of Trial StatusOngoing
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