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    Summary
    EudraCT Number:2022-000080-43
    Sponsor's Protocol Code Number:REMAD-02
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2022-06-10
    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 number2022-000080-43
    A.3Full title of the trial
    A randomized, placebo-controlled, double-blind, parallel-group Phase 2a exploratory study with placebo run-in to investigate PK/PD effects, safety, tolerability and pharmacokinetics of REM0046127 oral suspension compared with placebo in subjects with mild to moderate Alzheimer's disease
    Un estudio exploratorio de fase 2a, aleatorizado, controlado con placebo, doble ciego, de grupos paralelos con pre-inclusión de placebo para investigar los efectos PK/PD, la seguridad, la tolerabilidad y la farmacocinética de la suspensión oral REM0046127 en comparación con el placebo en sujetos masculinos y femeninos con enfermedad de alzheimer de leve a moderada
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2a, randomized, placebo-controlled, double-blind study to investigate REM0046127 in mild to moderate Alzheimer's disease
    Un estudio de fase 2a, aleatorizado, controlado con placebo, doble ciego para investigar REM0046127 en la enfermedad de Alzheimer de leve a moderada
    A.4.1Sponsor's protocol code numberREMAD-02
    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 SponsorreMYND
    B.1.3.4CountryBelgium
    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 supportreMYND NV
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNeuroScios GmbH
    B.5.2Functional name of contact pointCRO
    B.5.3 Address:
    B.5.3.1Street AddressWillersdorferstr. 7
    B.5.3.2Town/ citySt. Radegund
    B.5.3.3Post code8061
    B.5.3.4CountryAustria
    B.5.4Telephone number4331324044412
    B.5.5Fax number4331324044412
    B.5.6E-mailnhelmberg@neuroscios.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 nameREM0046127
    D.3.4Pharmaceutical form Oral suspension
    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 INNREM004
    D.3.9.1CAS number 1417823-67-6
    D.3.9.2Current sponsor codeREM004
    D.3.9.3Other descriptive nameREM0046127
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1400
    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 placeboOral suspension
    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
    Alzheimer's Disease
    Enfermedad de Alzheimer
    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 HLT
    E.1.2Classification code 10001897
    E.1.2Term Alzheimer's disease (incl subtypes)
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the tolerability and safety of each dose level.
    Evaluar la tolerabilidad y seguridad de cada nivel de dosis.
    E.2.2Secondary objectives of the trial
    NA
    NA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Mild to moderate AD as characterized by the following clinical, cognitive, and functional criteria.
    a. Biomarker profile reflecting AD, according to The National Institute on Aging—Alzheimer's Association (NIA-AA) Research Framework based on Screening CSF Aβ1-42 and p-tau concentrations
    b. Clear EEG deficit as assessed by the EEG reader
    c. MMSE score above 12 (preferably above 16) and a maximum of 24

    2. A brain imaging study, such as magnetic resonance imaging (MRI) and/or computed tomography (CT) scan having been performed within last 6 months from day of the Screening visit or during the Screening phase of this study consistent with the clinical diagnosis of AD and excluding other potential causes of dementia. If there has been a significant change in clinical status suggestive of stroke or other possible central neurological disease with onset between the time of the last MRI or CT and the Screening evaluation, an MRI scan should be repeated during Screening procedures if considered appropriate by the Investigator

    3. Age 50 to 85

    4. BMI above 18 and below 35 kg/m2 (preferably below 30 kg/m2)

    5. If taking concomitant medications, treated with stable doses of drugs essentially required for chronic medical conditions which do not lead to exclusion, during a period of at least 3 months prior to screening, and dose regimen is expected to remain stable during the conduct of the study

    6. If taking an approved cholinesterase inhibitor or NMDA antagonist for treatment of Alzheimer’s disease, treated with a stable dose for at least 6 months prior to the screening visit and the dose is not expected to change during the study as per investigators judgement, or must be off such Alzheimer medication for a period of 8 weeks prior to screening

    7. Willing and able to give informed consent.

    8. Have a caregiver who assists the participant every day and has intimate knowledge of the participant’s cognitive, functional, and emotional states and of the participant’s personal care. The caregiver must be willing to accompany the participant to all study visits and to supervise IMP administration as well as report adverse events. The caregiver must be willing and able to give informed consent for their own participation and be able to read and write

    9. Be able to read, write, speak clearly for the cognitive tests, with eyesight and hearing sufficient to enable completion of the cognitive tests
    1. 'Alzheimer' de leve a moderado caracterizado por los siguientes criterios clínicos, cognitivos y funcionales.
    a. Perfil de biomarcadores que refleja la EA, definido de acuerdo con el marco de investigación del NIA-AA (Instituto Nacional sobre el Envejecimiento - Asociación de Alzheimer), basado en las concentraciones de Aβ1-42 y p-tau en el LCR en el momento de la selección.
    b. Deficiencia evidente de EEG determinada por el lector de EEG.
    C. Puntuación MMSE superior a 12 (preferiblemente superior a 16) y máximo 24.
    2. Un estudio de imágenes cerebrales, como imágenes por resonancia magnética (IRM) y/o tomografía computarizada (TC), realizado en los últimos 6 meses a partir del día de la visita de selección o durante la fase de selección de este estudio de acuerdo con la clínica. Diagnóstico de EA y excluyendo otras posibles causas de demencia. Si ha habido un cambio significativo en el estado clínico indicativo de un accidente cerebrovascular u otra posible enfermedad neurológica central con inicio entre el momento de la última resonancia magnética o tomografía computarizada y la evaluación durante la selección, la exploración debe repetirse durante los procedimientos de selección si el investigador lo considera apropiado.
    3. Edad 50 a 85.
    4. IMC por encima de 18 y por debajo de 35 kg/m2 (preferiblemente por debajo de 30 kg/m2).
    5. Si toma medicamentos concomitantes, y el tratamiento es con dosis estables de medicamentos esencialmente necesarios para condiciones médicas crónicas que no conducen a la exclusión, durante un período de al menos 3 meses antes de la selección, y se espera que el régimen de dosis permanezca estable durante la realización del estudio.
    6. Si está tomando un inhibidor de la colinesterasa aprobado o un antagonista de NMDA para el tratamiento de la enfermedad de Alzheimer, tratado con una dosis estable durante al menos 6 meses antes de la visita de selección y no se espera que la dosis cambie durante el estudio según el criterio de los investigadores, o que no esté bajo ese tratamiento para el Alzheimer durante un período de 8 semanas antes de la selección.
    7. Dispuesto y capaz de dar su consentimiento informado.
    8. Contar con un cuidador que asista al participante todos los días y que tenga un conocimiento íntimo del estado cognitivo, funcional y emocional del participante y del cuidado personal del participante. El cuidador debe estar dispuesto a acompañar al participante a todas las visitas del estudio y supervisar la administración del fármaco del estudio e informar de las reacciones adversas. El cuidador debe estar dispuesto y ser capaz de dar su consentimiento informado para su propia participación, y saber leer y escribir.
    9. Ser capaz de leer, escribir y hablar claramente para las pruebas cognitivas, con capacidad visual y auditiva suficientes para permitir la realización de las pruebas cognitivas.
    E.4Principal exclusion criteria
    1. COVID-19 positive test at the screening visit

    2. Clinical, laboratory or neuro-imaging findings consistent with:
    i. Other primary degenerative dementia, (dementia with Lewy bodies, frontotemporal dementia, Huntington’s disease, Creutzfeldt-Jakob Disease, Down’s syndrome, etc.)
    ii. Other neurodegenerative condition (Parkinson’s disease, amyotrophic lateral sclerosis, etc.)
    iii. Cerebrovascular disease (major infarct, one strategic or multiple lacunar infarcts, extensive white matter lesions > one quarter of the total white matter)
    iv. Other central nervous system diseases (severe head trauma, tumors, subdural hematoma or other space occupying processes, etc.)
    v. Seizure disorder
    vi. Other infectious, metabolic or systemic diseases affecting central nervous system (syphilis, present hypothyroidism, present vitamin B12 or folate
    deficiency, serum electrolytes out of normal range, juvenile onset diabetes mellitus, etc.)

    3. Current presence of a clinically significant major psychiatric disorder according to the criteria of the DSM-IV, or symptom that could affect the subject's ability to complete the study

    4. Current clinically significant systemic illness, e.g., neoplasia, that is likely to result in deterioration of the subject's condition or affect the subject's safety during the study

    5. History of adrenal gland insufficiency

    6. History of severe post-lumbar puncture syndrome

    7. Abnormalities in the blood clotting system or abnormal coagulation status

    8. Women of childbearing potential.
    Refer to Appendix X for the definitions of woman of nonchildbearing potential.

    9. Male subjects with female partners of child-bearing potential who are unwilling or unable to adhere to contraception requirements

    10. Participation in another clinical study during the last 3 months

    11. Wheelchair-bound or bed-ridden

    12. Any other criteria which in the opinion of the Investigator causes the subject not to qualify for the study
    1. Prueba positiva de COVID-19 en la visita de selección
    2. Hallazgos clínicos, de laboratorio o de neuroimagen consistentes con:
    i. Otras demencias degenerativas primarias (demencia con cuerpos de Lewy, demencia fronto-temporal, enfermedad de Huntington, enfermedad de Creutzfeldt-Jakob, síndrome de Down, etc.)
    ii. Otra condición neurodegenerativa (enfermedad de Parkinson, esclerosis lateral amiotrófica, etc.)
    iii. Enfermedad cerebrovascular (infarto mayor, un infarto lacunar estratégico o múltiple, lesiones extensas de sustancia blanca > una cuarta parte de la sustancia blanca total)
    IV. Otras enfermedades del sistema nervioso central (traumatismos craneoencefálicos graves, tumores, hematoma subdural u otras patologías ocupantes de espacio, etc.)
    v. Trastorno convulsivo
    vi. Otras enfermedades infecciosas, metabólicas o sistémicas que afecten al sistema nervioso central (sífilis, hipotiroidismo presente, deficiencia de vitamina B12 o folato presente, electrolitos séricos fuera del rango normal, diabetes mellitus de inicio juvenil, etc.)
    3. Presencia actual de un trastorno psiquiátrico mayor clínicamente significativo según los criterios del DSM-IV, o síntomas que podría afectar la capacidad del sujeto para completar el estudio (p. ej., puntuación HAM-D >12)
    4. Enfermedad sistémica actual clínicamente significativa, p. ej., neoplasia, que probablemente resulte en el deterioro de la condición del sujeto o afecte la seguridad del sujeto durante el estudio.
    5. Historia de insuficiencia de las glándulas suprarrenales
    6. Historia de síndrome post-punción lumbar grave
    7. Anomalías en el sistema de coagulación de la sangre o estado de coagulación anormal
    8. Mujeres en edad fértil.
    Consulte el Apéndice X para conocer las definiciones de mujer en edad fértil.
    9. Sujetos masculinos con parejas femeninas en edad fértil que no desean o no pueden cumplir con los requisitos de anticoncepción
    10. Participación en otro estudio clínico durante los últimos 3 meses
    11. En silla de ruedas o postrado en cama
    12. Cualquier otro criterio que a juicio del Investigador haga que el sujeto no califique para el estudio
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of treatment-emergent adverse events
    Incidencia de eventos adversos emergentes del tratamiento
    E.5.1.1Timepoint(s) of evaluation of this end point
    AE: Placebo Run-in phase to Follow up Visit
    Reacciones adversas: Período de inicio del placebo hasta la visita de seguimiento
    E.5.2Secondary end point(s)
    NA
    NA
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    NA
    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 Yes
    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 trial3
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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 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
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state30
    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)
    'None'
    'Ninguno'
    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 Decision2022-08-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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