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    Summary
    EudraCT Number:2022-002987-57
    Sponsor's Protocol Code Number:AL002-LTE
    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:2023-01-16
    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 number2022-002987-57
    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
    Estudio multicéntrico de extensión a largo plazo para evaluar la seguridad, la tolerabilidad y la eficacia de AL002 en participantes con enfermedad de 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
    Ensayo clínico para evaluar AL002 en participantes con enfermedad de Alzheimer temprana
    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.5.4Telephone number+34900834223
    B.5.6E-mailRegistroEspanolDeEstudiosClinicos@druginfo.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.3.8INN - Proposed INNN/A
    D.3.9.1CAS number N/A
    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 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 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
    Enfermedad de Alzheimer temprana
    E.1.1.1Medical condition in easily understood language
    Alzheimer's Disease
    Enfermedad de 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.
    Evaluar la seguridad y la tolerabilidad a largo plazo del PEI (AL002) en participantes con EA.
    Evaluar el efecto de la inmunogenicidad al PEI sobre la seguridad, la FC y los biomarcadores FD en participantes con EA.
    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.
    To evaluate the effects of IMP in participants with AD on exploratory
    clinical outcome assessments (COAs) and PD biomarkers.
    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. El participante ha completado el periodo de tratamiento previsto del estudio AL002-2. La finalización completa del periodo de tratamiento previsto se refiere a todo participante que no haya suspendido de forma prematura y definitiva el PEI en el estudio AL002-2.
    2. El participante está dispuesto a otorgar su consentimiento informado y es capaz de hacerlo. Cuando las normas locales permitan la inclusión de participantes que no se consideren aptos para otorgar su consentimiento informado, un representante legal deberá otorgar su consentimiento informado en su nombre, y el posible participante deberá otorgar su asentimiento, de conformidad con las normas locales, las directrices y el Comité de Ética de la Investigación con medicamentos.
    3. El participante cuenta con una persona (“acompañante para el estudio”) que, en opinión del investigador, tiene un contacto frecuente y suficiente con el participante (p. ej., al menos 10 horas a la semana de contacto en persona), es capaz de proporcionar información exacta sobre la capacidad cognitiva y funcional del participante, se compromete a facilitar información en las visitas al centro (se necesitan datos aportados por el acompañante para cumplimentar las escalas) y firma el documento de consentimiento necesario.
    a. El acompañante para el estudio debe tener una capacidad cognitiva suficiente, en opinión del investigador, para informar con exactitud del comportamiento, la capacidad cognitiva y la capacidad funcional del participante. El acompañante para el estudio debe tener un estado general de salud suficientemente bueno, en opinión del investigador, de modo que haya muchas probabilidades de mantener el mismo nivel de interacción con el participante y de participación en los procedimientos del estudio durante la totalidad del estudio.
    b. Se hará todo lo posible para que el mismo acompañante para el estudio participe durante todo el estudio y para contar con el mismo acompañante para el estudio que participó en el estudio original.
    4. El participante y el acompañante para el estudio dominan bien el idioma de las pruebas utilizadas en el centro del estudio, según la valoración del personal del centro.
    5. El participante está dispuesto a completar todos los aspectos del estudio (como RMN, PL opcional, genotipificación y TEP opcionales, según proceda) y es capaz de hacerlo. El
    posible participante debe ser capaz de completar las evaluaciones solo o con la ayuda del acompañante para el estudio.
    6. El participante tiene una agudeza visual y auditiva adecuadas, en opinión del investigador, y suficientes para realizar las pruebas neuropsicológicas (se permite el uso de lentes correctoras y audífonos).
    7. El paciente se compromete a no donar sangre ni hemoderivados para transfusión a lo largo del estudio y durante 1 año después de la última dosis del fármaco del estudio.
    Criterios de inclusión exclusivamente para los participantes en la evaluación opcional de TEP-tau con [18F]MK-6240:
    8. El participante no ha tenido una exposición excesiva a la radiación antes de su inclusión en el ensayo, según lo definido por las normas locales.
    9. El centro de TEP dispone de [18F]MK-6240 según la red de fabricación y distribución y la normativa local.
    Criterios de inclusión exclusivamente para los participantes en la evaluación opcional de TEP-amiloide longitudinal:
    10. El participante no ha tenido una exposición excesiva a la radiación antes de su inclusión en el ensayo, según lo definido por las normas locales.
    11. El centro de TEP dispone de un radiomarcador de amiloide aprobado según la red de fabricación y distribución y la normativa local.
    Criterios de inclusión exclusivamente para los participantes en la evaluación opcional de WLSA en el domicilio y/o en el centro:
    12. Para la participación en el domicilio:
    a. El participante cuenta con un acompañante para el estudio dispuesto a pasar la escala WLSA.
    b. El participante tiene acceso WiFi en su residencia o en una zona privada donde pueda realizarse la prueba.
    c. El participante tiene acceso a un iPad o un iPhone.
    13. Para la participación en el domicilio y en el centro, el participante deberá tener la competencia lingüística necesaria para completar las evaluaciones propuestas y otras escalas de valoración clínica.
    E.4Principal exclusion criteria
    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. Participantes que, en opinión del investigador o de acuerdo con la normativa local, no son capaces de otorgar su consentimiento o asentimiento.
    2. Participantes que suspendieron de forma prematura y definitiva el tratamiento en el estudio original por motivos de seguridad.
    3. El participante presenta en la RMN signos de:
    a. >2 infartos lagunares.
    b. Cualquier infarto territorial >1 cm3.
    c. Lesiones hiperintensas de la sustancia blanca en la secuencia FLAIR que se correspondan con una puntuación global de Fazekas de 3.
    d. Se comentarán con el monitor médico los casos de participantes que presenten un aumento del número de microhemorragias >5 desde la RMN de selección/basal previa en el estudio AL002-2.
    e. Los participantes que hayan desarrollado ARIA-E y ARIA-H en el estudio original y a los que se haya permitido continuar con el tratamiento conforme a las directrices de tratamiento en caso de ARIA no serán excluidos de participar en el estudio AL002-LTE debido a microhemorragias o hemosiderosis.
    4. La participación en el estudio AL002-LTE se considera inadecuada por cualquier motivo a criterio del investigador.
    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
    • Incidencias de AA, incluidos los AAIE y AAG
    • Constantes vitales, resultados analíticos e incidencia de hallazgos en las exploraciones físicas, neurológicas y oftalmológicas y en los ECG
    • C-SSRS
    • Anomalías en la RMN
    • Evaluar el efecto del ajuste de la dosis sobre las 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
    • Incidencias de AA, incl los AAIE y AAG dte el estudio, dsd el momento que el pte firma el consentimiento hasta el fin de estudio • Constantes vitales en c/visita,resultados analíticos en la sem de selec 1,13,29,41yEOA/FP e incidencia d hallazgos en las explor fisicas durante el est, neurológicas y oftalmológicas en la sem selección 9,17,25,33,41,49yFDE/EPy los ECG en la selección, sem1,5,9,13,25,49yFDE/FP • C-SSRS_cada visita • Anomalías en la RMN_selección, sem 9,17,25,33,41 yFDE/FP • Evaluar el efecto del ajuste de la dosis sobre las ARIA_Paratodas las RMN posteriores a la sel, la RMN debe realizarse al menos 5días antes de la adm de la sig dosis y no más de 10 días antes de la adm de la sig dosis, con los resultados recibidos del proveedor central de imágenes antes de la dosificacion
    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, Aβ40, Aβ42, 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
    • MEC
    • Actualización de la RBANS
    • ADAS-Cog13
    • ADCS ADL-MCI
    • ADCOMS
    • Concentraciones de sTREM2 en LCR y/o plasma
    • Concentraciones de biomarcadores relacionados con la función de la microglía en el LCR y/o plasma (por ejemplo, CSF1R, IL1RN, osteopontina o YKL 40)
    • Concentraciones de biomarcadores relacionados con la patología de la EA en LCR y/o plasma (p. ej., Aβ40, Aβ42, pTau o tTau)
    • Concentraciones de biomarcadores de neurodegeneración en plasma y/o LCR (por ejemplo, NfL)
    • Volumen cerebral, evaluado mediante RMN volumétrica
    • Carga cerebral de proteína tau patológica determinada mediante TEP-tau longitudinal únicamente en los participantes que acepten participar en la evaluación opcional
    • Carga de amiloide cerebral determinada mediante TEP-amiloide longitudinal únicamente en los participantes que acepten participar en la evaluación opcional
    • Mediciones del habla mediante la escala WLSA únicamente en los participantes que acepten participar en esta evaluación opcional
    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,MEC,Actual RBANS,ADAS-Cog13,ADCS-ADL-MCI,ADCOMS en selec.,sem25&FDE/FP.Concentraciones de sTREM2 en LCR y/o plasma, Concent.de biomarc. relac con la función de la microglía enel LCR y/o plasma,Concent. de biomarc. relac. con la patología de la EA en LCR y/o plasma,Concent.de biomarc.de neurodegeneración en plasma y/o LCR,en el punto descrito en el protocolo y el calendario de eventos.Volumen cerebral,evaluado mte RMN volumétrica,Carga cerebral de proteína tau patológica determ. mte TEP-tau longitudinal únicamte en los part. que acepten participar en la evaluación opcional en la selección y FDE/FP.Carga de amiloide cerebral determinada mte TEP-amiloide longitudinal únicamte en los part. que acepten participar en la evaluación opcional Mediciones del habla en la selección y FDE/FP.
    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
    Tolerabilidad
    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
    Dosis ciega
    Dose Blind
    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 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 concerned9
    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 No
    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).
    El fin de estudio se define como la fecha en la que el último participante completa la última visita (incluida la visita FDE/FP)
    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
    E.8.9.2In all countries concerned by the trial years3
    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
    Pacientes con enfermedad de Alzheimer
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    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
    Ninguna
    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 Decision2023-02-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-12-14
    P. End of Trial
    P.End of Trial StatusOngoing
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